Podcasts about adcs

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Best podcasts about adcs

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Latest podcast episodes about adcs

The PowerShell Podcast
Jake Hildreth on PSConf EU, Stepper Updates, and Taking the Day Off

The PowerShell Podcast

Play Episode Listen Later Jul 20, 2026 45:46


Jake Hildreth, Principal Security Consultant at Semperis and Microsoft MVP, is back on the podcast fresh off a trip to PowerShell Conference Europe, where he and Andrew co-presented a session on securing PowerShell. Jake also gave his own talk on Stepper, his open-source module for building resumable, step-by-step scripts — a tool that's grown considerably since his last appearance on the show. The two dig into what makes PSConf EU such a standout event, the refreshing lack of elitism in the PowerShell community, and the updates Jake's been shipping, including named steps, built-in logging, and secret suppression. The conversation winds into burnout, the importance of actually taking your vacation days, and how the same mindset that drives good automation — knowing when to stop and reset — applies to taking care of yourself. Key Takeaways: Stepper has gotten some meaningful quality-of-life updates since Jake last appeared on the show, including named steps, automatic logging, and the ability to suppress secrets from logs — making it more practical for real-world production scripts. PSConf EU punches above its weight as a conference experience: technically deep but genuinely welcoming at every skill level, with none of the elitism that can creep into security-adjacent events. Your vacation time is a benefit, not a backlog item. Jake makes the case that getting good at separating your work time from your off time isn't a soft skill — it's a sustainability practice. Guest Bio: Jake Hildreth is a Principal Security Consultant at Semperis, a Microsoft MVP in both PowerShell and Identity/Access, and a recovering sysadmin with 25 years of IT under his belt. He's probably best known for building Locksmith, the open-source AD CS auditing and remediation tool, but he's also the creator of Stepper, Deck, BlueTuxedo, and PowerPUG! — a suite of tools designed to make identity security a little less painful for the admins who live in it. When he's not untangling Kerberos or chasing down ADCS misconfigurations, he goes by "horse" in the PowerShell Discords. Resource Links: Jake Hildreth's Website: jakehildreth.com Jake's GitHub: github.com/jakehildreth Stepper (Resumable PowerShell Scripts): github.com/jakehildreth/Stepper Locksmith (AD CS Auditing & Remediation): github.com/jakehildreth/Locksmith Locksmith 2 (Next-Gen AD CS Toolkit): github.com/jakehildreth/… PowerShell Conference Europe: psconf.eu PDQ Discord: discord.gg/PDQ The PowerShell Podcast on YouTube: https://youtu.be/Rqkuaeps_jM

Cancer Buzz
The Urology-Oncology Partnership in ADCs

Cancer Buzz

Play Episode Listen Later Jul 15, 2026 6:27


In 2025, the FDA approved the antibody-drug conjugate (ADC) enfortumab vedotin combined with pembrolizumab for patients with cisplatin-ineligible muscle-invasive bladder cancer, unlocking a new perioperative treatment option. To administer this ADC-based therapy alongside surgical intervention, multidisciplinary teams must prioritize collaborative workflows at all points of the treatment journey. In this episode, CANCER BUZZ speaks with Manojkumar Bupathi, MD, President of Rocky Mountain Cancer Centers, about how ADCs are reshaping the care model toward earlier, structured collaboration between urology and medical oncology. Guests: Manojkumar Bupathi, MD President Rocky Mountain Cancer Centers Co-Chair, GU Executive Committee Sarah Cannon Research Institute Denver, CO "The challenge wasn't learning the drug itself. The challenge was how you integrate the regimen into your treatment paradigm." —Manojkumar Bupathi, MD "There's always this relationship that happens from the beginning and is maintained throughout the entire process." —Manojkumar Bupathi, MD Resources: ACCC Bladder Cancer Resources ACCC Antibody-Drug Conjugate Resources  

The Chain: Protein Engineering Podcast
Episode: 87 - Jack Elands on How Novel ADC Payloads Could Improve Cancer Care

The Chain: Protein Engineering Podcast

Play Episode Listen Later Jul 14, 2026 45:08 Transcription Available


July 14, 2026 | Most ADCs today lean on the same Topo-1 payloads—and resistance is catching up. Jack Elands, Ph.D., founder and CEO of Adcytherix, speaks with host Rakesh Dixit, Ph.D. about what “next-generation ADCs” should mean if we care about patients, not just pipeline counts. Their conversation gets specific about where differentiation comes from: novel payloads with new mechanisms of action, better therapeutic index choices, and smarter design decisions that reduce the toxicities that make patients quit therapy early. They also pressure-test the hype around bispecific ADCs and dual-payload ADCs.  Links from this episode:  Adcytherix 

Pharma and BioTech Daily
Ipsen's Dysport Hits Phase 3 Milestone vs. Botox | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jul 10, 2026 5:13


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant advancements and challenges shaping the landscape of these dynamic sectors. Starting with Ipsen's Dysport, which has made notable strides in its Phase 3 trials for migraine prevention. The trials covered both episodic and chronic conditions, marking a first in the neurotoxin market. Dysport's success positions it as a formidable competitor to AbbVie's Botox, expanding therapeutic options for individuals battling migraine disorders. This achievement showcases the potential efficacy of botulinum toxin-based therapies in neurology and pain management, offering promising new avenues for patient care. In regulatory news, Boehringer Ingelheim has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for Jascayd, a small molecule PDE4B inhibitor with antifibrotic properties. This approval marks a significant milestone in the treatment of idiopathic and progressive pulmonary fibrosis. Jascayd's addition to the therapeutic arsenal offers new hope for managing this debilitating condition, emphasizing the ongoing efforts to improve patient outcomes through innovative treatments. The arena of business development sees HanChorBio partnering with InxMed to advance oncology research. By combining HCB101 with FAK inhibitors and FAP-targeted ADCs, this collaboration aims to leverage antibody and small molecule drug discovery techniques. The goal is to develop innovative cancer treatments that could redefine therapeutic approaches in oncology. Keenova Therapeutics has also reported success with Xiaflex for plantar fibromatosis. This enzyme injection therapy offers a novel approach by targeting collagen, thus providing an innovative solution for musculoskeletal conditions. Similarly, Fate Therapeutics' FT819, an off-the-shelf CAR-T therapy, has shown early promise in tackling treatment-resistant systemic sclerosis, underscoring the potential of cell therapies beyond oncology. Meanwhile, MindRank's successful Series B funding round of $52 million highlights the growing role of AI platforms in drug discovery. The funding will propel its AI-discovered oral GLP-1 obesity pill into Phase III trials, exemplifying how technology-driven solutions are gaining traction in addressing metabolic diseases like obesity. On the regulatory front, Saol Therapeutics has resubmitted SL1009 (DCA) to the FDA for pyruvate dehydrogenase complex deficiency. This submission underscores ongoing efforts to address rare metabolic disorders using small molecule therapies. Additionally, Sanofi's concessions to the EU regarding flu vaccine marketing illustrate the complexities of competitive dynamics and regulatory scrutiny within the vaccine market. However, not all developments are favorable. AstraZeneca and Ionis Pharmaceuticals faced a setback as their drug Wainua failed its Phase 3 trial for transthyretin-mediated amyloid cardiomyopathy. This outcome highlights the challenges inherent in developing effective treatments for complex cardiovascular conditions. Meanwhile, regulatory processes remain contentious as the FDA pauses its release of complete response letters amid debates over proprietary information disclosures. In another noteworthy development, GSK has terminated its $2.2 billion collaboration with Alector after underwhelming results from Alzheimer's drug trials. This decision highlights both financial implications and strategic shifts as companies reassess risk tolerance in neurodegenerative disease research. Conversely, Roche's success with its KRAS G12C inhibitor divarasib in Phase 3 lung cancer trials underscores the promise of precision medicine. Divarasib outperformed competitors Amgen's Lumakras and Bristol Myers Squibb's Krazati, positioning Roche to potentially redefine standards of care based on genetic profiles. In a move reflecting industry trends towards collaboration and innovation risk-sharing models, AstraZeneca has partnered with Sino Biopharmaceutical on respiratory disease research. This strategic alliance represents a substantial investment aimed at expanding AstraZeneca's pipeline in respiratory therapeutics. Lastly, amidst these developments, psychedelic drugs are experiencing a renaissance in psychiatric care. Companies like Compass Pathways are pioneering clinical validation for their use in treating depression, signaling a potential paradigm shift from traditional SSRIs to newer therapeutic classes pending safety and efficacy data. Overall, these stories illustrate a dynamic interplay of scientific progress and regulatory navigation within the pharmaceutical and biotech sectors. While challenges persist—particularly in neurodegenerative disease treatment—the breakthroughs in oncology and metabolic disorder therapeutics offer hopeful prospects for improving patient care. As these industries continue evolving, integrating advanced technologies such as AI will likely play a pivotal role in shaping future therapeutic landscapes.Support the show

Cancer Buzz
A Team Approach to ADCs in Bladder Cancer

Cancer Buzz

Play Episode Listen Later Jul 8, 2026 9:59


At the University of California, San Francisco (UCSF), the team treating patients with bladder cancer and other genitourinary malignancies utilizes a multidisciplinary team approach to ensure care is coordinated, personalized, and patient-centered. This is particularly important when administering antibody-drug conjugates, a promising tool for some patients with muscle-invasive bladder cancer that comes with a high risk of adverse events (AEs). In this episode, CANCER BUZZ speaks with Terence Friedlander, MD, and Iva Petrovchich Colón, NP, both part of the team treating bladder cancer at UCSF, about how their cancer program manages the toxicity profile of ADCs in order to prioritize patient outcomes and quality of life. Guests: Terence Friedlander, MD Robert and Virginia O'Reilly Family Professor of Medicine Chief of Hematology-Oncology, Zuckerberg San Francisco General Hospital UCSF Helen Diller Family Comprehensive Cancer Center  San Francisco, CA Iva Colón, NP Nurse Practitioner, Genitourinary Medical Oncology UCSF Health Genitourinary Medical Oncology Mission Bay San Francisco, CA "The median onset is in the mid 60s, and folks who are in their 60s are more mature, they may have more comorbidities, more medical problems, and we have to be really sensitive to that." —Terence Friedlander, MD "It takes a village and having that having open and direct communication is key." —Iva Colón, NP Resources: ACCC Bladder Cancer Resources ACCC Antibody-Drug Conjugate Resources  

Research To Practice | Oncology Videos
Antibody-Drug Conjugates in the Management of Breast Cancer — Proceedings from a Session Held in Conjunction with the 2026 ASCO Annual Meeting

Research To Practice | Oncology Videos

Play Episode Listen Later Jul 8, 2026 120:01


Featuring perspectives from Prof Giuseppe Curigliano, Prof Rebecca A Dent, Dr Erika Hamilton, Prof Nadia Harbeck and Dr Hope S Rugo, moderated by Dr Rugo, including the following topics: Introduction (00:00) Evolving Role of Antibody-Drug Conjugates (ADCs) in the Management of Metastatic Triple-Negative Breast Cancer — Prof Dent (02:57) Integrating ADCs into the Management of HER2-Positive Metastatic Breast Cancer (mBC) — Prof Curigliano (29:01) Role of ADCs in the Management of Endocrine-Resistant Hormone Receptor-Positive mBC — Dr Rugo (52:36) Emerging Utility of ADCs for Localized Breast Cancer — Prof Harbeck (01:14:36) Tolerability Considerations with ADCs for Breast Cancer — Dr Hamilton (01:38:10) CME information and select publications

ScienceLink
Chicago 2026: Lo más destacado en Tumores Ginecológicos

ScienceLink

Play Episode Listen Later Jul 8, 2026 19:54


n este episodio especial de Chicago 2026: Lo más destacado en Tumores Ginecológicos, centrado en la evidencia más relevante de la reunión anual de la Sociedad Americana de Oncología Clínica, la Dra. Laura Venegas y el Dr. Eduardo González, expertos en ginecología oncológica, analizan las actualizaciones más relevante en tumores ginecológicos.El debate principal destaca la consolidación de los conjugados anticuerpo-fármaco (ADC) y su expansión hacia líneas más tempranas de tratamiento. En el contexto del cáncer de ovario platino-resistente y platino-sensible, se evalúa la eficacia de nuevos blancos terapéuticos como HER2 (estudio T-Bren), c-MET, y la combinación de mirvetuximab con carboplatino (estudio MIROVA). Además, se discuten los avances en terapias dirigidas no citotóxicas, incluyendo el inhibidor multiquinasa chiauranib (estudio CHIPOR), el antagonista de receptores de glucocorticoides relacorilant (estudio ROSELLA) y los inhibidores de CDK2 (estudio MAESTRA-2).En el ámbito de la inmunooncología, el episodio aborda enfoques para transformar el microambiente tumoral del cáncer de ovario, tradicionalmente considerado “inmunológicamente frío”. Se analizan los resultados de terapias celulares autólogas contra PRAME (IMA203CD8), vacunas de neoantígenos como mantenimiento (PESCO y estudio 122101) y la inhibición dual con anticuerpos anti-CTLA-4 como gotistobart combinado con pembrolizumab (PRESERVE-004). Por otro lado, en el cáncer de endometrio, se consolida el estándar de tratamiento en primera línea mediante la presentación de los datos de supervivencia a largo plazo (4 años de seguimiento) de los estudios fase III RUBY (dostarlimab) y NRG-GY018 (pembrolizumab), subrayando su potencial curativo en la población con dMMR.Finalmente, el análisis se extiende al cáncer cervicouterino recurrente o metastásico, un escenario con necesidades clínicas no cubiertas donde las terapias estándar tras la progresión son limitadas. La introducción de ADC de nueva generación dirigidos contra Trop-2 y Nectina-4 emerge como una estrategia prometedora. La sesión concluye haciendo énfasis en que el principal reto a corto plazo para la comunidad oncológica será la adecuada secuenciación terapéutica y el uso riguroso de la medicina traslacional y biomarcación para la selección de pacientes en la práctica clínica diaria.Preguntas realizadas durante el episodio:¿Cuál es el impacto de la diversificación de blancos terapéuticos y el reto de la secuenciación de los ADCs en el cáncer de ovario?¿Qué implican los datos a largo plazo de los estudios RUBY y GY018 respecto al potencial curativo de la inmunoterapia en cáncer de endometrio?¿Cómo modificará la introducción de ADC dirigidos contra Trop-2 y Nectina-4 el algoritmo de tratamiento actual en el cáncer cervicouterino recurrente o metastásico?Ante la multiplicidad de nuevos mecanismos de acción, ¿cuál será el rol determinante de la biomarcación para optimizar la toma de decisiones clínicas?Referencia:Este contenido se basa en la interpretación crítica de la evidencia científica disponible, así como en la experiencia clínica del o los ponentes como profesionales de la salud en instituciones de referencia.Para profundizar en los conceptos discutidos, se recomienda al profesional de la salud consultar literatura científica vigente, guías clínicas internacionales y la normatividad aplicable en su país.

OncLive® On Air
S17 Ep45: Medical Crossfire®: Precision Oncology in NSCLC – Translating HER2 and TROP2 Innovation into Practice-Changing Care

OncLive® On Air

Play Episode Listen Later Jul 7, 2026 32:18


Highlights from the PER® CME activity "Medical Crossfire®: Precision Oncology in NSCLC – Translating HER2 and TROP2 Innovation into Practice-Changing Care" — this podcast is not certified for credit. To participate in the full accredited activity and earn CME credit, use the link below.In this podcast, focusing on precision oncology in non-small cell lung cancer (NSCLC), experts Helena Yu, MD; Jacob Sands, MD; and Sarah Goldberg MD, MPH; will discuss the rapidly evolving landscape of Human Epidermal growth factor Receptor 2 (HER2)- and Trophoblast cell-surface antigen 2 (TROP2)-directed therapies in NSCLC. The podcast covers the spectrum of targeted agents from antibody-drug conjugates (ADCs) to novel HER2-selective tyrosine kinase inhibitors (TKIs), along with key clinical trial data and practical strategies for managing the unique adverse event profiles associated with these treatments.Earn CME credit by completing the full accredited activity (available through June 30, 2027): https://www.gotoper.com/courses/medical-crossfire-precision-oncology-in-nsclc-translating-her2-and-trop2-innovation-into-practice-changing-care-mr5qThis podcast, including the narration, was developed by PER® (Physicians' Education Resource®, LLC) editorial staff from the full online CME activity developed with these faculty. The narration was voiced by a PER staff member or by an AI tool. The podcast contains no product advertising. The full activity is supported by educational grants from AstraZeneca Pharmaceuticals; Daiichi Sankyo, Inc.; and Gilead Sciences, Inc.This content is for educational purposes only and is not a substitute for the independent clinical judgment of a health care professional. Faculty may discuss investigational or off-label uses; consult prescribing information for any products discussed.

Pharma and BioTech Daily
Novartis' $1.1B Myricx Acquisition Boosts ADC Pipeline | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jul 7, 2026 5:12


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The first quarter of 2026 has brought a wave of significant changes and advancements in the industry, marked by crucial regulatory updates, strategic acquisitions, and shifts in the competitive landscape. A pressing issue for many companies is the looming patent cliff for several branded biologics. This situation presents both challenges and opportunities for biosimilars in the U.S. market. The introduction of biosimilars for major products like AbbVie's Humira, Johnson & Johnson's Stelara, and Regeneron/Bayer's Eylea is shifting the narrative from slow adoption to a more competitive biosimilar market landscape. Vertex Pharmaceuticals has achieved a milestone with the FDA expanding the label for its gene therapy Casgevy, now approved for treating children as young as two with sickle cell disease or transfusion-dependent beta thalassemia. This expansion emphasizes the potential of gene therapies to revolutionize treatment options for younger patients suffering from these conditions. In a pivotal development, Novartis announced a significant acquisition of UK biotech Myricx. With an upfront payment of $1.1 billion and potential total value up to $1.5 billion, this acquisition is set to enhance Novartis' antibody-drug conjugate (ADC) pipeline by incorporating Myricx's novel payload technology and NMT inhibitor payloads. This move reflects Novartis' focus on precision oncology by improving ADC efficacy through targeting critical enzymatic pathways involved in tumorigenesis. Amgen faced a setback with a voluntary recall of approximately one million bottles of its heart medication Corlanor due to potential contamination, highlighting the critical importance of maintaining rigorous manufacturing quality control to ensure drug safety. The regulatory landscape continues to evolve, illustrated by Robert F. Kennedy Jr.'s Department of Health and Human Services revoking lingering COVID-19 emergency authorizations. This signals a transition towards post-pandemic normalcy and an evolving focus on pandemic preparedness frameworks. Sanofi's Genzyme unit in Ireland faced criticism after an FDA inspection linked to Altuviiio resulted in a Form 483 notice. This incident underscores ongoing challenges in maintaining compliance with stringent regulatory standards and emphasizes the importance of robust quality assurance mechanisms. Lonza is expanding its capacity for producing ADCs and enhancing its partnership with a large U.S. drugmaker, aligning with industry trends toward outsourcing complex biologics manufacturing amid growing demand for ADCs. Genentech is undergoing restructuring, resulting in 103 layoffs as part of a strategic rethink of its early development group. Despite these changes, Genentech entered a $490 million collaboration focused on breast cancer, demonstrating its commitment to innovation amid organizational shifts. AstraZeneca continued its collaborative efforts by signing a $1.7 billion kidney drug discovery pact with Chinese biotech CSPC Pharmaceutical. This partnership emphasizes AstraZeneca's strategy to leverage global collaborations to accelerate drug discovery and development efforts. Scribe Therapeutics filed for an Initial Public Offering (IPO) to advance its CRISPR-based gene editing technologies targeting cardiovascular diseases at a genetic level, highlighting an ongoing shift toward personalized medicine. Celea Therapeutics raised $180 million in venture funding to advance Deupirfenidone into late-stage clinical trials for Idiopathic Pulmonary Fibrosis (IPF), signaling confidence in its therapeutic potential amid ongoing investment trends targeting rare diseases. The Medicines and Healthcare products Regulatory Agency expanded approval for Novo Nordisk's Wegovy for Metabolic-Associated Steatohepatitis with moderate-to-advanced liver fibrosis. This expansion represents significant progress given MASH's rising prevalence and progression risks. BridgeBio's ATTRibute-CM study yielded promising results with Acoramidis offering kidney-protective benefits in transthyretin amyloidosis cardiomyopathy patients—a potential new approach managing this rare disease. Revolution Medicines reported encouraging data for its KRAS inhibitor Zoldonrasib in combination therapies targeting metastatic pancreatic ductal adenocarcinoma—offering new strategies against aggressive cancer types. Brii Bio's phase 2b trial results show promise for a combination therapy aimed at achieving a functional cure for chronic Hepatitis B Virus infection—offering hope for millions affected by this condition. Robust fundraising activities continue within biotech sectors as Monash University and Atisama Therapeutics secure funding from MRFF grants developing therapies targeting chronic lung diseases. Overall, these developments highlight dynamic transformations reshaping therapeutic landscapes through precision medicine approaches leveraging cutting-edge technologies promising improved patient care across various domains within pharmaceutical industries globally.Support the show

Oncology Brothers
Sacituzumab +/- Pembrolizumab FDA Approval in Triple Negative Breast Cancer: ASCENT-03 / ASCENT-04

Oncology Brothers

Play Episode Listen Later Jul 4, 2026 20:39


In this episode of the Oncology Brothers podcast, we dived deep into the recent FDA approvals for sacituzumab govitecan in frontline settings for metastatic triple-negative breast cancer. Joined by Dr. Sara Tolaney, a breast medical oncologist from the Dana-Farber Cancer Institute, we discussed the exciting developments in breast cancer treatment, with ASCENT-03 and ASCENT-04 trials.   Key topics covered in this episode include: Overview of the recent FDA approvals for antibody-drug conjugates (ADCs) in breast cancer Detailed discussion on the ASCENT-04 trial focusing on PD-L1–positive metastatic triple-negative breast cancer Insights into the ASCENT-03 trial for PD-L1–negative disease Comparison of sacituzumab govitecan and datopotamab deruxtecan (Dato-DXd), including their efficacy and side effect profiles Management strategies for common side effects such as neutropenia and diarrhea   Listen us on: Spotify: https://open.spotify.com/show/31BXhY9FM4gPWG10WgE11o  Follow us on social media: ⁠X/Twitter: https://x.com/oncbrothers  Instagram: https://www.instagram.com/oncbrothers  Website: https://oncbrothers.com/    Join us as we explored the evolving landscape of breast cancer treatment and the importance of shared decision-making in patient care. Don't forget to like, subscribe, and hit the notification bell for more updates from the Oncology Brothers! #TripleNegativeBreastCancer, #Sacituzumab, #ASCENT03, #ASCENT04, #OncologyBrothers

Oncology Brothers
ASCO 2026 Breast Highlights: OPTIMA, lidERA, VIKTORIA-1, KEYNOTE-522, ASCENT-03/04, TROPION-Breast02

Oncology Brothers

Play Episode Listen Later Jul 2, 2026 31:25


In this ASCO 2026 Highlights discussion we dived into the latest advancements in breast cancer space. In this episode, we welcomed back Dr. Hope Rugo to discuss key studies that are shaping the future of breast cancer treatment.   Episode Highlights: OPTIMA: Discover how the Prosigna genomic assay could change the approach to adjuvant chemotherapy in hormone receptor-positive breast cancer. lidERA Update: Learn about the promising results of giredestrant, an oral SERD, and its potential role in adjuvant settings. VIKTORIA-1: Exploring the implications of gedatolisib for PIK3CA mutated disease and its impact on progression-free survival. Triple Negative Breast Cancer: Insights on the final overall survival updates from the KEYNOTE-522 and the exciting developments in antibody-drug conjugates (ADCs) like sasitizumab through ASCENT-03 and ASCENT-04 studies, and datopotamab from TROPION-Breast02 study.   Listen us on: Spotify: https://open.spotify.com/show/31BXhY9FM4gPWG10WgE11o   Follow us on social media: ⁠ ⁠X/Twitter: https://x.com/oncbrothers ⁠ ⁠Instagram: https://www.instagram.com/oncbrothers ⁠ Website: https://oncbrothers.com/   Hope this episode provided the very needed updates from ASCO 2026 focusing on the breast cancer world. Don't forget to like, subscribe, and hit the notification bell for more updates from the Oncology Brothers!   #BreastCancer #ASCO2026 #ClinicalTrials #PrecisionOncology #OncologyBrothers

OncLive® On Air
S17 Ep39: Sequencing and Emerging Targets Revamp the Platinum-Resistant Ovarian Cancer Treatment Paradigm: With David O'Malley, MD

OncLive® On Air

Play Episode Listen Later Jun 30, 2026 17:55


In today's episode, we spoke with David O'Malley, MD. Dr O'Malley is a professor in the Department of Obstetrics and Gynecology at The Ohio State University College of Medicine and the director of the Division of Gynecologic Oncology at The Ohio State University Comprehensive Cancer Center–James in Columbus, Ohio. In our exclusive interview, Dr O'Malley discussed his approach to treatment selection and sequencing in platinum-resistant ovarian cancer, a disease setting he described as representing the highest unmet need in the field. He emphasized the central role of clinical trial enrollment and biomarker-driven decision-making, alongside practical patient-centered considerations, such as infusion schedule and quality of life.He highlighted the growing importance of antibody-drug conjugates (ADCs) in this setting, noting that folate receptor alpha and HER2 are the two biomarkers most relevant to current practice. Dr O'Malley outlined how National Comprehensive Cancer Network guidelines support treatment across a broader range of expression levels than initial approvals reflected, citing emerging data suggesting activity even at lower expression thresholds. He also addressed payload sequencing, explaining that outside of a clinical trial, he currently uses topoisomerase I–based ADCs and antimicrotubule-based ADCs each one time only, and remains open to targeting the same antigen again if the payload differs.The discussion also touched on combination strategies, resistance biology, and the evolving role of immunotherapy following the survival benefit observed with pembrolizumab (Keytruda) in the phase 3 KEYNOTE-B96 trial (NCT05116189). Dr O'Malley expressed enthusiasm for next-generation payloads, dual-target approaches, and the potential for bispecific antibodies and novel DNA damage response–targeting agents to define the post-ADC treatment landscape.Finally, Dr O'Malley underscored the need for more tumor biopsies to better characterize resistance mechanisms and called for expanded pharmaceutical investment in retreatment and cross-resistance studies to guide future sequencing decisions.

EVA CAST - o podcast do Grupo Brasileiro de Tumores Ginecológicos
EVA CAST #44 - Câncer de endométrio: a perspectiva da paciente

EVA CAST - o podcast do Grupo Brasileiro de Tumores Ginecológicos

Play Episode Listen Later Jun 30, 2026 65:19


O episódio 44 do EVA CAST, o podcast do Grupo Brasileiro de Tumores Ginecológicos, aborda o câncer de endométrio sob uma perspectiva que integra informação científica, atualização médica e a experiência de quem enfrentou a doença. Embora seja o câncer ginecológico mais frequente nos países desenvolvidos e venha apresentando aumento de incidência em diferentes regiões do mundo, o tema ainda é pouco conhecido pela população. Muitas mulheres só ouvem falar sobre a doença quando recebem o diagnóstico.Participam da conversa Juliana Passos, oncologista clínica do Hospital Felício Rocho e da Santa Casa de Belo Horizonte; Pedro Ribeiro, oncologista do Grupo Orizonti e do Instituto de Oncologia Ciências Médicas e membro do Grupo Brasileiro de Tumores Ginecológicos (EVA); e Maiara Peres, paciente, membro do Comitê do Instituto Oncoguia, do Comitê de Ética em Pesquisa do Instituto Paliar e cofundadora do Gicecocancer, iniciativa voltada a pacientes com cânceres ginecológicos. Ao longo do episódio, os convidados discutem os principais sinais de alerta da doença, os desafios do diagnóstico e os avanços que vêm modificando o tratamento do câncer de endométrio.Entre os temas abordados estão as diferenças entre o câncer de endométrio e o câncer do colo do útero, a importância do sangramento após a menopausa como sinal de alerta, o papel do ultrassom transvaginal e da biópsia na investigação diagnóstica e os limites do exame de Papanicolau, frequentemente associado de forma equivocada ao diagnóstico desse tipo de câncer. O episódio também traduz conceitos que costumam gerar dúvidas, como tipo histológico, grau e estadiamento tumoral, tornando essas informações mais acessíveis para pacientes e familiares.A conversa explora ainda como o perfil molecular passou a ocupar papel central na definição do tratamento. Os especialistas explicam por que testes moleculares podem modificar a conduta terapêutica e discutem a incorporação da imunoterapia ao tratamento do câncer de endométrio, além das perspectivas abertas por novas estratégias terapêuticas, como os anticorpos conjugados a drogas (ADCs), especialmente para pacientes com doença avançada.Outro eixo importante do episódio é a experiência da paciente ao longo da jornada. Maiara Peres compartilha como foi reconhecer os primeiros sinais, enfrentar o período de investigação diagnóstica e lidar com o impacto emocional da confirmação da doença. A conversa destaca a importância da informação de qualidade, do apoio familiar, da equipe multiprofissional e do contato com outras pacientes como elementos fundamentais para atravessar esse processo com mais segurança e acolhimento.Como mensagem final, os convidados reforçam que o câncer de endométrio, quando diagnosticado precocemente, apresenta elevadas chances de tratamento bem-sucedido e que conhecer os sinais de alerta, buscar avaliação médica diante de sintomas persistentes e compreender as opções terapêuticas disponíveis são passos fundamentais para um cuidado mais efetivo e humanizado.

CME Outfitters, LLC Podcasts
A CaseWise™ Webcast: From Research to Real-World: ADCs, IO Combinations, and Sequencing in Metastatic NSCLC

CME Outfitters, LLC Podcasts

Play Episode Listen Later Jun 24, 2026 67:46


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Smart Biotech Scientist | Bioprocess CMC Development, Biologics Manufacturing & Scale-up for Busy Scientists
262: How to Stop Defaulting to CHO: An Evidence-Based Host Selection Framework for Biologics

Smart Biotech Scientist | Bioprocess CMC Development, Biologics Manufacturing & Scale-up for Busy Scientists

Play Episode Listen Later Jun 18, 2026 15:38


Host David Brühlmann returns for a focused solo episode to provide an honest, data-driven perspective on the evolving landscape of host selection for biologics manufacturing. Building on part one, David reviews five alternative expression platforms and offers a clear, practical framework for scientists navigating host cell decisions today. David Brühlmann moves past simplistic "replacement" narratives to instead examine where each technology, from plant farming to cell-free systems, fits in today's market and production realities.Key topics discussedWhy asking if a novel host will "replace CHO" is the wrong question for scientists and manufacturers (00:11)Critical dimensions to evaluate: cost structure, speed, and intrinsic product quality (01:20)Review of five alternative platforms with current clinical and regulatory status: Plant farming for speed and decentralization (03:42)Insect cells for VLPs and complex proteins (05:00)Cell-free protein synthesis for ADCs and unique conjugation requirements (06:23)Moss for monoclonal antibodies with distinct glycosylation patterns (07:50)Filamentous fungi for high secretion and thermotolerance (08:47)A practical host selection framework by molecule type and manufacturing context (09:59)Detailed constraints and advantages of each platform, including cost, infrastructure, timeline, and product attributes (10:09)Analysis of silkworm production as a disruptive possibility for future biologics manufacturing (13:09)The evolving toolkit available to bioprocess scientists—and why "CHO replacement" is a distraction from more relevant questions (12:06)Smart insight:The real development over the past decade is that bioprocess scientists now have a credible, validated toolkit of alternatives for specific molecules in specific contexts. The practical implication: know this landscape well enough to ask the right host selection question at program initiation, before you've built months of process development around a platform you chose by default.Here are the episodes referenced:Episodes 163 - 164: How Moss Enables Production of Unproducible Protein Therapeutics with Andreas SchaafEpisodes 141 - 142: How Microalgae Cuts Antibody Costs by 70% and Redefines Biomanufacturing with Muriel BardorEpisodes 235 - 236: Plant-Based Biomanufacturing: How Molecular Farming Produces Biopharmaceuticals in Weeks, Not Months with Waranyoo PhoolcharoenEpisodes 217 - 218: Silkworm Biomanufacturing: From Ancient Silk Production to Phase I Vaccine Trials with Masafumi OsawaEpisodes 229 - 230: Cyanobacteria Biomanufacturing: Achieving Carbon-Neutral Production at Lower Cost Than Fermentation with Tim CorcoranNext:If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode.Support the show

Digital Pathology Podcast
240: AI-Powered Companion Diagnostics: The Future of Precision Medicine | Podcast with Dr Bowman

Digital Pathology Podcast

Play Episode Listen Later Jun 17, 2026 41:05 Transcription Available


Send us Fan MailHow far can pathologists take visual biomarker scoring before human vision becomes the bottleneck?In this episode, I talk with Doug Bowman. PhD, VP Precision Medicine at Indica Labs, about what happens when companion diagnostics move from traditional visual scoring into the era of AI-powered image analysis. Doug comes from a biomedical and electrical engineering background, with experience in microscopy, digital image analysis, pharma workflows, and now precision medicine at Indica Labs. That combination makes him a great person to talk to about how image analysis actually fits into real companion diagnostic development.We start with a very practical question: what is a companion diagnostic, and why is it becoming so important in precision medicine? Doug explains that companion diagnostics are developed alongside therapeutics to help identify which patients are most likely to benefit from a specific treatment, especially in more complex therapies like antibody-drug conjugates (ADCs). We use HER2 as an example, and from there we get into the real challenge: once a biomarker cutoff matters clinically, visual estimation around that cutoff becomes much harder than many people want to admit.That is where this conversation gets especially useful for pathologists and digital pathology trailblazers. We talk about the limits of human vision, why low or ultra-low biomarker expression is difficult to score consistently, and how AI helps at multiple levels of the workflow: slide QC, tissue classification, cell segmentation, membrane and cytoplasmic measurement, and spatial analysis. Doug makes the case that AI is not only a convenience here. In some cases, it is the only realistic way to capture the kind of quantitative information modern therapies need.We also get into one of the more interesting examples from the episode: the Trop2 story, where a ratio of cytoplasmic to membrane expression appears to predict therapeutic efficacy better than looking at one compartment alone. That kind of compartment-level quantitation is exactly where computational pathology becomes more than a digital version of what the eye already does. It starts uncovering measurements and signatures the eye cannot reliably extract on its own.Another important part of the discussion is workflow and regulation. Doug walks through how AI-powered companion diagnostics are developed from preclinical work, to human feasibility studies, to RUO or clinical trial assays, and eventually toward analytical and clinical validation with regulatory engagement happening early. We also talk about the Indica Labs and Leica Biosystems partnership, and why end-to-end capability matters when you are trying to build something clinically deployable rather than just analytically interesting.What I liked about this conversation is that it stayed grounded. We did not talk about AI as magic. We talked about image analysis as a method, companion diagnostics as a workflow, and precision medicine as something that only works when the measurement is good enough to support real decisions.Episode Highlights00:00 – Why AI matters in slide QC, tissue classification, and cell-level analysis before you even get to the biomarker score.00:54 – Doug Bowman's background in biomedical engineering, microscopy, and digital image analysis.05:16 – What a companion diagnostic actually is, and why it is critical for targeted therapies and ADCs.07:34 – Why visual biomarker scoring becomes unreliable around critical cutoffs, especially in low-expression cases.10:09 – How AI expands the workflow: slide QC, tissue classification, and precise cell segmentation.13:07 – Why pathologists remain central in AI workflows through validation, markup review, and model refinement.16:31 – The Trop2 example: when cytoplasmic-to-membrane ratio tells you more than one compartment alone.20:23 – The Indica Labs + Leica Biosystems partnership and why end-to-end workflow matters in companion diagnostics.22:53 – What the development journey looks like from early algorithm work to RUO, validation, and regulatory interaction.26:51 – Multiplexing, spatial analysis, and why more clinical value often comes with more deployment complexity.33:29 – Why image analysis literacy matters, and how shared language between pathologists and scientists becomes essential.40:13 – Where to learn more about Indica Labs and who to contact for collaboration.Resources mentionedIndica Labs Indica Labs contact – info@indicalab.comHALO software / HALO AI diagnostic image analysis – discussed in the context of companion diagnostic deployment and pharma services.Leica Biosystems GT450DX – referenced as an FDA-cleared slide scanner in the Indica-Leica partnership.Digital Pathology Association – mentioned as part of the broader educational ecosystem for digital pathology and image analysis.Digital Pathology Place / Digital Pathology Podcast – the platform hosting this conversation and related education around digital pathology and AI.Support the showGet the "Digital Pathology 101" FREE E-book and join us!

The Uromigos
Episode 510: ADCs in Prostate Cancer

The Uromigos

Play Episode Listen Later Jun 15, 2026 30:23


Tanya Dorff joins Tom and Brian to discuss her ASCO 2026 data on a novel dual targeting ADC in prostate cancer. The broader scope of ADC development in prostate cancer is discussed with a focus on cytopenia toxicity and future direcctions.

BioTalk Unzipped
The Future of Oncology Drug Development | Dr. Lakshmi Amaravadi

BioTalk Unzipped

Play Episode Listen Later Jun 11, 2026 29:41 Transcription Available


Oncology drug development is becoming more complex, and bioanalysis can no longer be treated as simple drug measurement.Sponsored by Leucentra, https://leucentra.com/Inspired by science, empowered by IT. Leucentra helps life science and healthcare organizations evaluate, implement, and get more value from technology that supports innovation.In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe speak with Dr. Lakshmi Amaravadi, Head of Oncology Bioanalysis at AstraZeneca, live from AAPS PharmSci 360 in San Antonio.Dr. Amaravadi unpacks why biomarker validation is not one-size-fits-all, how context of use should guide scientific decision making, and why fit-for-purpose validation matters in modern oncology drug development.The conversation explores:00:00 Why oncology bioanalysis is becoming more complex02:12 FDA biomarker validation guidance and industry response04:27 What “fit for purpose” means in practice06:38 PK assay validation vs biomarker assay validation07:52 What drives Dr. Amaravadi's work in translational science10:48 Why validation is not a checkbox exercise12:19 Advice for young scientists entering bioanalysis15:12 Why oncology drug development is uniquely complex18:17 ADCs, bispecifics, T-cell engagers, and conditional T-cell engagers19:38 Why bioanalysis now requires understanding biology20:46 Dr. Amaravadi's path from molecular biology to bioanalysis24:34 Critical reagent management in complex oncology assays26:42 Validation, qualification, and context of use29:03 Final thoughts from AAPS PharmSci 360This episode is especially relevant for scientists, bioanalytical leaders, translational researchers, clinical pharmacologists, oncology development teams, biomarker scientists, and anyone working at the intersection of drug development, assay validation, and precision medicine.Dr. Amaravadi discusses how oncology programs now involve ADCs, bispecifics, T-cell engagers, conditional T-cell engagers, complex linkers, multiple measurable species, immunogenicity considerations, and biomarker strategies that require deeper biological understanding. As she explains in the episode, the future of oncology bioanalysis is not simply measuring what is present. It is understanding what the measurement means in the context of the biology and the development decision.Follow BioTalk Unzipped for conversations with leaders in biotech, pharma, bioanalysis, clinical development, translational science, regulatory strategy, and the future of medicine.GuestDr. Lakshmi Amaravadihttps://www.linkedin.com/in/lakshmi-amaravadi/HostsGregory Austinhttps://www.linkedin.com/in/gregoryaustin1/Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/Sponsor: LeucentraRelated LinksCelerionhttps://www.celerion.com/

The NACE Clinical Highlights Show
CME/CE Podcast - Integrating TROP2-Directed ADCs into TNBC Treatment Plans: Novel Aspects of Efficacy and Safety Profiles

The NACE Clinical Highlights Show

Play Episode Listen Later Jun 10, 2026 27:05


For more information regarding this CME/CE activity and to complete the CME/CE requirements and claim credit for this activity, visit:https://www.mycme.com/courses/the-evolving-role-of-antibody-drug-conjugates-in-metastatic-triple-negative-breast-cancer-10800SummaryThis CME/CE-certified podcast will provide multidisciplinary clinicians with an evidence-based update on the evolving role of TROP2-directed antibody-drug conjugates (ADCs) in the frontline treatment of metastatic triple-negative breast cancer. A medical and an ocular oncology specialist review the latest efficacy and safety data from pivotal clinical trials evaluating ADCs, their integration into contemporary treatment algorithms, and guideline recommendations based on PD-L1 status, BRCA mutation status, and immunotherapy eligibility. Learners will explore key factors influencing treatment selection, compare the benefits and limitations of more established therapeutic options, and examine practical strategies for preventing, recognizing, and managing ADC-associated toxicities. Special emphasis will be placed on multidisciplinary approaches to the management of ocular adverse events and other clinically significant toxicities to optimize patient outcomes and support safe implementation of these therapies in clinical practice.Learning ObjectivesEvaluate the current and emerging clinical evidence surrounding the use of trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugates (ADCs) in the first-line treatment of metastatic triple-negative breast cancer (TNBC)Integrate TROP2-directed ADCs into frontline treatment regimens for metastatic TNBC based on the latest clinical evidence, guidelines, and patient- and tumor-specific factorsApply multidisciplinary and patient-centric strategies for the prevention, recognition, and management of toxicities associated with the use of TROP2-directed ADCs in patients with metastatic TNBCThis activity is accredited for CME/CE CreditThe National Association for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.The National Association for Continuing Education designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.The National Association for Continuing Education is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 121222. This activity is approved for 0.50 contact hours (which includes 0.50 hours of pharmacology). For additional information about the accreditation of this program, please contact NACE at info@naceonline.com.Faculty and Moderator Aditya Bardia, MDProgram Director, Breast Medical Oncology, UCLAProfessor of Medicine, UCLALos Angeles, CADr. Bardia has disclosed the following financial relationships:Consultant: Alyssum, AstraZeneca/Daiichi, BMS, Eli Lilly, Genentech, Gilead, Menarini, Merck, Novartis, Pfizer, VyomeAdvisor/Advisory Board: Alyssum, AstraZeneca/Daiichi, Eli Lilly, Genentech, Gilead, Menarini, Merck, Novartis, Pfizer, VyomeContracted Research: AstraZeneca/Daiichi, Eli Lilly, Genentech, Gilead, Menarini, Merck, Novartis, PfizerStock options: Vyome (immuno-inflammatory and rare diseases)All of his consultant, advisor/advisory board, and contracted research disclosures are related to cancer.Maura Di Nicola, MDAssistant Professor of OphthalmologyBascom Palmer Eye InstituteMedical Director of Imaging and EchographyBascom Palmer Eye InstituteMiami, FLDr. Di Nicola has disclosed the following financial relationships:Consultant: AbbVie (ophthalmology), SpringWorks Therapeutics (oncology)Advisor/Advisory Board: AbbVie (ophthalmology)Research Grant: Castle Biosciences (ocular oncology)Please review additional planner disclosures here.Disclosure of Commercial SupportThis educational activity is supported by a medical education grant from AstraZeneca Pharmaceuticals and a medical education grant from Daiichi Sankyo, Inc.Please visit  http://naceonline.com to engage in more live and on demand CME/CE content.

Pharma and BioTech Daily
Merck & Gilead's HIV Pill Breakthrough: Phase 3 Success! | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jun 10, 2026 5:23


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The landscape of these industries is one of constant evolution, characterized by scientific advancements, strategic mergers, and regulatory maneuvers that shape the future of healthcare. In a significant scientific breakthrough, Merck & Co. and Gilead Sciences have made strides in HIV treatment with the development of a weekly pill. This innovative regimen combines Merck's islatravir with Gilead's lenacapavir, showing promise in two phase 3 trials. If approved, this long-acting oral therapy could revolutionize HIV care by offering a more convenient dosing schedule, potentially improving patient adherence and outcomes substantially. This novel regimen signifies progress towards simplifying HIV treatments with once-weekly dosing. Meanwhile, in the oncology sector, Gilead's Trodelvy faced challenges when combined with Merck's Keytruda as a first-line treatment for PD-L1-high non-small cell lung cancer. The phase 3 EVOKE-03 trial was terminated, shifting attention to competitors like AstraZeneca and Daiichi Sankyo, who continue to advance their own therapies in this area. In a strategic move to bolster its position in lung cancer treatment, GlaxoSmithKline (GSK) is acquiring Nuvalent for $10.6 billion, aiming to secure near-approval cancer therapies capable of challenging market leaders like Roche and Pfizer. This acquisition underscores the focus on targeted cancer therapies that increase treatment efficacy by honing in on specific genetic markers. Nuvalent's innovative pipeline of small molecule inhibitors targets drug resistance and mutations in cancer treatment—a strategic addition to GSK's portfolio aimed at enhancing its position amidst rapid advancements and intense competition in oncology. In diabetes and obesity management, Eli Lilly is advancing with its new oral GLP-1 receptor agonist, Foundayo (orforglipron), which has shown competitive efficacy over oral semaglutide. Analysts see Lilly's progress as strengthening its leadership in the growing obesity drug market. Similarly, AstraZeneca is making progress with its own GLP-1 candidate, elecoglipron, as phase 2 data sets the stage for pivotal studies. Promising clinical trial data from Eli Lilly's retatrutide for obesity-related conditions and AstraZeneca's elecoglipron suggest a strengthening pipeline for GLP-1 receptor agonists known for their dual effects on weight management and glycemic control. On the diagnostics front, Roche reaffirms its €600 million investment in Germany amid industry retrenchments by companies like Eli Lilly and Boehringer Ingelheim. However, Roche remains cautious about future risks due to shifting economic conditions. The financial dynamics within biotech are also noteworthy. Parabilis Medicines is planning a potentially record-setting IPO following Kailera Therapeutics' successful public offering earlier this year. These trends indicate strong investor confidence and an influx of funding towards innovative cancer therapies. Meanwhile, CeQur's $100 million Series E funding round aims at accelerating insulin patch delivery systems' commercial growth—highlighting ongoing innovation in diabetes management solutions. Regulatory updates reveal AstraZeneca facing reprimands from the UK marketing watchdog due to repeated breaches related to LinkedIn activities—an ongoing challenge in pharmaceutical marketing compliance. The integration of digital health solutions continues apace as ixlayer partners with Vertex Pharmaceuticals to launch a digital acute pain management platform. This initiative aims at improving patient care by reducing reliance on opioid-based treatments. These developments paint a picture of an industry where scientific innovations, regulatory hurdles, and technological advancements intersect to shape future therapeutic landscapes. Precision oncology is another area witnessing substantial growth. The landscape also sees notable activity in rare disease therapeutics. Johnson & Johnson's Talvey has gained acceptance in Scotland for treating relapsed multiple myeloma using bispecific antibody technology—a trend toward leveraging immune system targeting technologies to enhance cancer treatment efficacy. Moreover, Zai Lab's Tivdak received approval from China's NMPA for cervical cancer treatment based on Phase 3 data, highlighting the rise of antibody-drug conjugates (ADCs) as potent oncology therapies due to their targeted delivery mechanisms. On the research collaboration front, AlzeCure Pharma's partnership with Eli Lilly focuses on Alzheimer's disease research through Alzstatin ACD680—a small molecule targeting neurodegenerative pathways—a testament to the collaborative efforts needed to tackle complex diseases like Alzheimer's. However, challenges persist as Bial discontinued its GCase activator program after failing Phase 2b trials for Parkinson's patients with GBA1 variants—a stark reminder of the high-risk nature inherent in drug development despite initial promise. These myriad developments underscore a vibrant period within pharmaceutical and biotech sectors where scientific advancements rapidly translate into actionable therapies promising substantial improvements in patient care by addressing unmet medical needs globally.Support the show

Vanguards of Health Care by Bloomberg Intelligence
AstraZeneca's ASCO Readout on Oncology's Next Wave

Vanguards of Health Care by Bloomberg Intelligence

Play Episode Listen Later Jun 9, 2026 57:59 Transcription Available


“I think it’s the most exciting period in cancer discovery and development that I’ve experienced over the last 25 years,” says Susan Galbraith, executive vice president of oncology R&D at AstraZeneca. Galbraith joins Bloomberg Intelligence analyst Sam Fazeli fresh from the ASCO conference to unpack how ctDNA, earlier intervention and next-generation oncology platforms could reshape cancer care. They discuss AstraZeneca’s Stride regimen in liver cancer, Serena-6 in breast cancer, progress in pancreatic cancer and the company’s push across ADCs, bispecifics, CAR-T and radio conjugates.See omnystudio.com/listener for privacy information.

PeerVoice Clinical Pharmacology Audio
Javier Cortés, MD, PhD / Laura Huppert, MD - Novel Uses for Trusted Tools: Investigational Approaches for TROP2-Directed ADCs in Advanced Breast Cancer

PeerVoice Clinical Pharmacology Audio

Play Episode Listen Later Jun 5, 2026 19:41


Javier Cortés, MD, PhD / Laura Huppert, MD - Novel Uses for Trusted Tools: Investigational Approaches for TROP2-Directed ADCs in Advanced Breast Cancer

PeerVoice Oncology & Haematology Video
Javier Cortés, MD, PhD / Laura Huppert, MD - Novel Uses for Trusted Tools: Investigational Approaches for TROP2-Directed ADCs in Advanced Breast Cancer

PeerVoice Oncology & Haematology Video

Play Episode Listen Later Jun 5, 2026 19:41


Javier Cortés, MD, PhD / Laura Huppert, MD - Novel Uses for Trusted Tools: Investigational Approaches for TROP2-Directed ADCs in Advanced Breast Cancer

PeerVoice Oncology & Haematology Audio
Javier Cortés, MD, PhD / Laura Huppert, MD - Novel Uses for Trusted Tools: Investigational Approaches for TROP2-Directed ADCs in Advanced Breast Cancer

PeerVoice Oncology & Haematology Audio

Play Episode Listen Later Jun 5, 2026 19:41


Javier Cortés, MD, PhD / Laura Huppert, MD - Novel Uses for Trusted Tools: Investigational Approaches for TROP2-Directed ADCs in Advanced Breast Cancer

PeerVoice Internal Medicine Audio
Javier Cortés, MD, PhD / Laura Huppert, MD - Novel Uses for Trusted Tools: Investigational Approaches for TROP2-Directed ADCs in Advanced Breast Cancer

PeerVoice Internal Medicine Audio

Play Episode Listen Later Jun 5, 2026 19:41


Javier Cortés, MD, PhD / Laura Huppert, MD - Novel Uses for Trusted Tools: Investigational Approaches for TROP2-Directed ADCs in Advanced Breast Cancer

Cancer Buzz
Data-Driven Toxicity Management for ADCs

Cancer Buzz

Play Episode Listen Later Jun 3, 2026 7:42


Toxicities related to antibody-drug conjugates (ADCs) can significantly impact quality of life for patients with locally advanced or metastatic bladder cancer, but data-driven programs can help multidisciplinary teams manage some of the most challenging adverse events. In this episode, CANCER BUZZ speaks with Cindy Y. Jiang, MD, assistant professor at MD Anderson Cancer Center, about how her institution conducted and implemented research to aid management of rashes and peripheral neuropathy associated with the ADC enfortumab vedotin combined with pembrolizumab. Guest:  Cindy Y. Jiang, MD Assistant Professor Department of GU Medical Oncology MD Anderson Cancer Center Houston, TX "It's important to assemble this team before you start on any sort of journey, because as oncologists, we're definitely not experts in skin rashes or neurological issues, and so you really need to rely heavily on those collaborators." — Cindy Y. Jiang, MD Resources: Bladder Cancer Antibody-Drug Conjugates

Pharma and BioTech Daily
Akeso's Ivonescimab Shows 34% Death Risk Cut at ASCO | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Jun 2, 2026 5:26


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a range of fascinating advancements in the industry, each with significant implications for future patient care and drug development. At the recent American Society of Clinical Oncology (ASCO) 2026 conference, Akeso's ivonescimab, a pioneering PD-1xVEGF bispecific antibody, demonstrated a 34% reduction in death risk when combined with chemotherapy for first-line lung cancer treatment. This marks a pivotal moment in cancer therapeutics, illustrating how bispecific antibodies can enhance treatment efficacy. The evolving landscape of cancer treatment continues to highlight the importance of these innovative approaches. Johnson & Johnson's Erleada has shown promising results in prostate cancer, achieving positive outcomes in its Phase 3 Proteus study. The trial emphasized the efficacy of Erleada when administered perioperatively to prostate cancer patients, indicating a shift towards more personalized and comprehensive care that incorporates targeted therapies before and after surgery. In another significant breakthrough, Lilly's Retemvo exhibited dramatic results in early-stage lung cancer with RET fusion-positive markers, reducing disease progression or death by 83% as adjuvant therapy. This underscores the critical role of molecularly targeted therapies for patients with specific genetic profiles, offering hope for improved survival outcomes. On the frontlines of infectious diseases, Shionogi's COVID-19 antiviral Xocova has received FDA approval as a post-exposure prophylactic. This milestone highlights the challenging yet dynamic landscape of antiviral drug development, offering a new tool in managing COVID-19 exposures after previous challenges in demonstrating effectiveness as a treatment. MannKind's inhaled insulin, Afrezza, has been approved for pediatric use. This approval could rejuvenate its market presence by providing a more convenient insulin delivery system aimed at improving adherence and glycemic control among younger patients. In oncology news, Pfizer's Talzenna combination therapy received broader FDA approval for castration-sensitive prostate cancer. This positions it as a competitive option against Johnson & Johnson's PARP inhibitor combination therapy. Additionally, AstraZeneca's Imfinzi and Imjudo combination showed promise in early-stage liver cancer by reducing disease progression risks by 30%, broadening immunotherapy applications. The market dynamics are also shifting with significant strategic movements like Eli Lilly's acquisition of Kelonia Therapeutics for $3.2 billion. This decision is driven by promising in vivo CAR-T data demonstrating unprecedented response rates and reflects the increasing importance of innovative CAR-T therapies in oncology. Eli Lilly's Kelonia Therapeutics' cell therapy showcased an impressive 100% response rate in a Phase 1 trial for relapsed or refractory multiple myeloma. This CAR-T therapy targets the BCMA antigen and could revolutionize treatment paradigms by offering more effective responses. Meanwhile, Pfizer's transformative research on RAS inhibitors holds potential to redefine treatment paradigms in pancreatic cancer—a notoriously difficult-to-treat type due to its complex biology. Revolution Medicines aims to maintain its leadership within this space amidst growing competition. Revolution Medicines also reported compelling results with their KRAS inhibitor, which nearly doubles survival rates for metastatic pancreatic cancer patients harboring KRAS mutations. Given the historically poor prognosis associated with pancreatic cancer, these findings represent a significant advancement in managing this aggressive type. In ovarian cancer research, Gilead's TUB-040 demonstrated a 61% tumor response rate for platinum-resistant ovarian cancer in a Phase 1 trial. This highlights the potential of antibody-drug conjugates (ADCs) to overcome resistance mechanisms and improve outcomes in difficult-to-treat cancers. Regulatory updates include Johnson & Johnson receiving FDA label expansion for Tremfya to inhibit structural joint damage in active psoriatic arthritis patients. This expansion provides broader treatment options for patients suffering from debilitating conditions by reinforcing the role of IL-23 inhibitors in autoimmune disease management. Strategic partnerships are also shaping drug development's future landscape. Notably, Servier's acquisition of Edgewise Therapeutics' muscular dystrophy unit underscores growing focus on rare diseases and neuromuscular disorders. Eli Lilly's agreements with Haisco Pharmaceutical and Hanmi Pharm reflect ongoing R&D investments aimed at expanding therapeutic portfolios across various indications. These developments illustrate a broader trend toward personalized medicine and targeted therapies that enhance treatment efficacy by leveraging specific genetic or molecular characteristics. Despite advancements, challenges remain as exemplified by Oculis' OCS-01 failing Phase 3 trials for diabetic macular edema—highlighting inherent risks in drug development. Overall, these updates underscore significant scientific progress and promise improvements in patient outcomes through novel therapeutic approaches and collaborative efforts within this vibrant industry landscape.Support the show

ReachMD CME
Chairperson's Perspective: HER2 in Solid Tumors – From Pathology to Personalized Treatment Plans

ReachMD CME

Play Episode Listen Later Jun 1, 2026 18:00


CME credits: 0.25 Valid until: 01-06-2027 Claim your CME credit at https://reachmd.com/programs/cme/chairpersons-perspective-her2-in-solid-tumors-from-pathology-to-personalized-treatment-plans/54582/ Dr. Kathleen Moore reviews the clinical significance of HER2 expression across diverse solid tumors and its role in guiding treatment decisions. She outlines HER2 testing methodologies, including immunohistochemistry (IHC), to identify patients with advanced solid tumors who may benefit from HER2-targeted antibody–drug conjugates (ADCs). Dr. Moore summarizes key data from trials such as DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 that supported tumor-agnostic approval of trastuzumab deruxtecan (T-DXd) for previously treated metastatic HER2-positive (IHC 3+) solid tumors, along with strategies for proactive monitoring and management of ADC-associated adverse events.=

The Uromigos
Episode 504: ASCO 2026 - ADC Drug Development in Urothelial Cancer

The Uromigos

Play Episode Listen Later May 29, 2026 40:32


This episode with Gopa Iyer from MSKCC explores the latest advances in antibody drug conjugates (ADCs) in urothelial cancer, including data from EV302, novel ADCs targeting Nectin-4, and sequencing strategies. Experts discuss efficacy, safety, biomarkers, and future directions in bladder cancer treatment.

Pharma and BioTech Daily
Eli Lilly's Zepbound Coverage Restored! Breaking News | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later May 29, 2026 5:43


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Recent updates offer a fascinating glimpse into an industry marked by dynamic shifts and groundbreaking advancements, each promising to reshape the future of healthcare. Let's delve into some of the most notable developments that are capturing attention across the globe. Starting with Eli Lilly's obesity medication, Zepbound, which has regained insurance coverage through CVS Caremark. This decision is emblematic of a broader recognition of obesity as a significant health issue that demands comprehensive treatment solutions. The reinstatement of coverage enables more patients to access Zepbound, potentially setting a benchmark for other insurers and leading to improved health outcomes. Shifting focus to oncology, AbbVie has secured FDA approval for a new therapy derived from its acquisition of ImmunoGen, adding to its portfolio of antibody-drug conjugates (ADCs) with Elahere. This development underscores the escalating value of ADCs in precision cancer therapies, offering innovative solutions for targeting cancer cells while preserving healthy tissues. Japan's pharmaceutical R&D stance is under examination as Prime Minister Sanae Takaichi meets with over 20 industry leaders to discuss maintaining the nation's competitive edge. This gathering highlights a global race among nations to enhance their R&D capabilities, ensuring leadership in pharmaceutical innovations. In neuroscience, Novartis's relentless pursuit to conquer the blood-brain barrier reflects ongoing efforts to revolutionize treatments for neurological disorders. Despite recent advancements, Novartis continues to explore new strategies for drug delivery to the brain, aiming to unlock therapies for conditions like Alzheimer's and Parkinson's disease. Viridian Therapeutics' collaboration with Wuxi Biologics marks a notable push in the eye drug market, positioning them against major players like Amgen. This partnership emphasizes manufacturing capability as a critical factor in ensuring resilient supply chains and competitive advantage. The hepatitis B treatment landscape has witnessed significant progress with GSK's phase 3 trial results for its drug Bepirovirsen. Achieving a functional cure in around one-fifth of patients signifies a major step forward in addressing this widespread disease. The potential to reduce lifelong antiviral therapy and lower liver cancer rates illustrates the transformative impact of nucleic acid-based therapies. Leadership dynamics also play a crucial role in pharma strategies. PharmaEssentia's appointment of Eric Vogel highlights the industry's reliance on seasoned talent to drive market expansion and broaden therapeutic indications, particularly for its rare blood cancer drug Besremi. In longevity research, Human Longevity's collaboration with Insilico Medicine introduces Human Life Foundation Models (HLFM), leveraging AI and genomics to extend human lifespan. This initiative is part of a broader trend integrating cutting-edge technologies into healthcare research, reflecting an evolving focus on longevity and genomic sciences. Regulatory landscapes are also evolving, as seen with CMS finalizing changes to the No Surprises Act dispute resolution process. By streamlining arbitration amidst rising disputes, these updates aim to refine healthcare policy frameworks for more efficient stakeholder service. Meanwhile, biosimilar approvals are gaining traction globally. ANVISA's approval of EMS's Ozivy in Brazil introduces a cost-effective alternative to Novo Nordisk's semaglutide (Ozempic) for type 2 diabetes. This step enhances access to affordable diabetes treatments, crucial for managing this prevalent metabolic disorder. In clinical trials innovation, D&D Pharmatech's Zabopegdutide has shown promising Phase 2 results for metabolic dysfunction-associated steatohepatitis (MASH), indicating fibrosis improvement and potential disease resolution. These findings underscore dual receptor agonists' therapeutic promise in tackling complex metabolic conditions. Additionally, Kailera Therapeutics' KAI-4729 demonstrates significant weight loss in Phase 1 obesity trials, potentially reshaping the obesity treatment landscape by offering superior weight management options compared to existing therapies. Funding rounds like Secretome Therapeutics' successful $30 million Series A highlight ongoing investments in regenerative medicine and cell-based therapies, propelling advancements in cardiovascular disease treatment pipelines. The acquisition landscape remains active with CordenPharma's purchase of AmbioPharm, expanding peptide manufacturing capabilities across U.S. and China markets. This move meets growing demand for peptide APIs vital in drug development processes. Technological innovation remains pivotal as Biohub releases an AI World Model for protein biology to expedite therapeutic discovery processes. This tool exemplifies computational biology's integration into drug discovery efforts, enhancing efficiency and innovation. Overall, these developments illustrate a vibrant pharmaceutical and biotech landscape characterized by scientific breakthroughs, strategic partnerships, regulatory achievements, and technological advancements—all aimed at advancing patient care and expanding therapeutic possibilities across diverse medical domains. As these trends continue unfolding, they promise not only improved treatment outcomes but also a more robust global healthcare ecosystem committed to innovation and excellence. Thank you for tuning into Pharma Daily; stay informed as we continue bringing you the latest from this rapidly evolving industry.Support the show

BioCentury This Week
Ep. 368 - ASCO Preview, China Policy, ADC Linkers

BioCentury This Week

Play Episode Listen Later May 27, 2026 33:46 Transcription Available


At ASCO among presentations focused on pancreatic cancer innovation beyond KRAS; however, abstracts for the cancer conference also highlight ADCs, bispecifics and diagnostics that are broadening the field's approach to the cancer. On the latest BioCentury This Week podcast, BioCentury's analysts discuss Revolution's daraxonrasib, other readouts to watch for in pancreatic cancer and what else is on BioCentury's radar at this year's American Society of Clinical Oncology meeting.BioCentury's analysts also discuss a push by China hawks in Congress to get the Trump administration to invoke national security powers to narrow Chinese life sciences companies' access to U.S. markets, technology and capital; an initiative by Rep. Jake Auchincloss (D-Mass.) that seeks to modernize how clinical trials are conducted in the U.S.; and a BioCentury analysis on new antibody-drug conjugate linker techniques. This episode of the BioCentury podcast is brought to you by Jeito Capital.View full story: https://www.biocentury.com/article/659581 #Biopharma #ASCO2026 #PancreaticCancer #ClinicalTrials #ADCInnovation00:01 - Sponsor Message: Jeito Capital02:26 - ASCO Preview14:24 - U.S. China Policy22:48 - Modernizing U.S. trials27:17 - Optimizing ADC LinkersTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

OncLive® On Air
S17 Ep27: Advances in Cervical Cancer: Prevention, Immunotherapy, and the Rise of Antibody-Drug Conjugates: With Ursula A. Matulonis, MD; and Meghan E. Shea, MD

OncLive® On Air

Play Episode Listen Later May 27, 2026 15:34


From Discovery to Delivery: Charting Progress in Gynecologic Oncology, hosted by Ursula A. Matulonis, MD, brings expert insights into the most recent breakthroughs, evolving standards, and emerging therapies across gynecologic cancers. Dr Matulonis is chief of the Division of Gynecologic Oncology and the Brock-Wilson Family Chair at the Dana-Farber Cancer Institute, as well as a professor of medicine at Harvard Medical School, both in Boston, Massachusetts.In this episode, Dr Matulonis was joined by Meghan E. Shea, MD, an attending medical oncologist and ambulatory medical director and disease program leader for medical oncology at Beth Israel Deaconess Medical Center in Boston. Together, they explored the current landscape of cervical cancer, from the urgent need for expanded vaccination and screening to the evolving role of immunotherapy and antibody-drug conjugates (ADCs) across disease settings.Dr Shea opened by addressing the epidemiology of cervical cancer, noting that despite decades of progress, rates are now plateauing and rising among women under 50 years of age. She identified 3 interrelated drivers of this trend: declining rates of routine gynecologic screening, inconsistent uptake of human papillomavirus (HPV) vaccination, and persistent high-risk HPV infections, particularly HPV 16 and 18, which are responsible for most cases. The conversation then turned to the effect of immunotherapy on cervical cancer treatment. Dr Shea traced the evolution of pembrolizumab (Keytruda) from its initial 2018 approval as a single agent in recurrent/metastatic disease to its more recent integration into the frontline setting. The phase 3 KEYNOTE-A18 trial (NCT04221945) demonstrated that adding pembrolizumab to standard weekly cisplatin-based chemoradiation significantly improved outcomes for patients with locally advanced disease. Although responses to immunotherapy, when they occur, are often durable, Dr Shea acknowledged that response rates remain lower than anticipated for a virally driven malignancy, underscoring the need for novel combinations and a deeper understanding of resistance mechanisms. Drs Matulonis and Shea both agreed that immunotherapy combined with ADCs represents one of the most compelling directions for the field, with phase 2 data for sacituzumab tirumotecan plus pembrolizumab generating interest ahead of anticipated phase 3 results.On the ADC front, Dr Shea reviewed the 2 agents in this class that are currently FDA-approved for cervical cancer. Tisotumab vedotin-tftv (Tivdak) offers the advantage of biomarker-independent use, though its requirement for ophthalmologic monitoring at every treatment visit creates real-world access challenges outside major academic centers. Trastuzumab deruxtecan-nxki (Enhertu), approved in the HER2 immunohistochemistry 3+ setting based in part on the results of the phase 2 DESTINY-PanTumor02 trial (NCT04482309), has generated robust response rates but is most likely to benefit patients with adenocarcinoma. Dr Shea also highlighted additional targets under investigation, including Trop-2, Nectin-4, and B7-H4, with multiple phase 3 trials ongoing in both the frontline and recurrent settings.The discussion closed with a look at the locally advanced disease landscape, where the NRG Oncology cooperative group is conducting a phase 3 trial to evaluate whether integrating the neoadjuvant carboplatin/paclitaxel regimen from the INTERLACE trial (NCT01566240) with the pembrolizumab-based regimen from KEYNOTE-A18 can further improve outcomes and reduce the morbidity associated with brachytherapy. Dr Shea expressed optimism about this question, citing preliminary experience suggesting that neoadjuvant chemotherapy may reduce the need for invasive radiation techniques.

Oncology Brothers
ESMO Breast 2026 Highlights - VERITAC-2, PREcoopERA, PHERGain, SATEEN/BRE-354, TROPION-Breast02

Oncology Brothers

Play Episode Listen Later May 26, 2026 21:45


Welcome back to the Oncology Brothers podcast! In this episode, we were joined by Dr. Erika Hamilton from the Sarah Cannon Cancer Research Institute to discuss the latest advancements in breast cancer treatment following ESMO Breast 2026. Listen us on: Spotify: https://open.spotify.com/show/31BXhY9FM4gPWG10WgE11o Apple Podcast: https://podcasts.apple.com/us/podcast/oncology-brothers-practice-changing-cancer-discussions/id1653340966 Follow us on social media: X/Twitter: https://twitter.com/oncbrothers ⁠Instagram: https://www.instagram.com/oncbrothers Website: https://oncbrothers.com/ We dived into key studies and recent FDA approvals, including: The exciting approval of Vepdegestrant from the VERITAC-2 study for ESR1-mutated breast cancer. The importance of ovarian function suppression in premenopausal patients, even with the advent of oral SERDs. Updates on HER2-positive disease treatments, including the newly approved T-DXd in neoadjuvant settings and the implications of de-escalation strategies. Insights from the SATEEN and BRE-354 studies on the use of antibody-drug conjugates (ADCs) after previous ADC treatments. A look at the Dato-DXd and Sacituzumab in frontline triple-negative breast cancer and how to choose between them. Join us as we unpack these critical findings and their implications for clinical practice. Don't forget to check out our other episodes for more treatment algorithms and conference highlights. Stay tuned for ASCO 2026, and remember, we are the Oncology Brothers! #ESMO2026, #ESR1mutation, #BreastCancerResearch, #PrecisionMedicine, #OncologyBrothers

Pharma and BioTech Daily
AstraZeneca's Datroway FDA Approved for TNBC | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later May 25, 2026 5:47


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of noteworthy advancements and challenges that are shifting the landscape of drug development and patient care. Starting with AstraZeneca and Daiichi Sankyo, their Trop2-directed antibody-drug conjugate, Datroway, has secured FDA approval for first-line treatment in triple-negative breast cancer. This form of cancer is notoriously aggressive and offers limited treatment options, making this approval a significant milestone. It positions Datroway as a key player in the ADC market targeting TNBC, highlighting the increasing role of antibody-drug conjugates in oncology. This advancement not only expands therapeutic options for patients but also emphasizes the growing importance of ADCs in effectively targeting cancer cells while sparing healthy tissues. In another exciting development, Merck and Kelun Biotech have reported on their SAC-TMT ADC, which when paired with Keytruda, shows a profound impact on PD-L1-positive non-small cell lung cancer patients. Their combination therapy demonstrated a remarkable 65% reduction in disease progression or death compared to Keytruda alone. Presented at the ASCO annual meeting, these findings could potentially revolutionize first-line treatments for NSCLC, further underscoring the promising therapeutic potential of combining ADCs with immunotherapies. However, AstraZeneca faced a setback with a novel breast cancer drug as an FDA advisory committee recommended against its approval. Interestingly, the European Medicines Agency provided a favorable opinion, illustrating the divergent regulatory landscapes across continents. Such discrepancies highlight the complex regulatory environment pharmaceutical companies must navigate and could influence strategic decisions regarding market focus. On the legal front, Eli Lilly is embroiled in controversy over an alleged $200 million rebate fraud scheme involving its diabetes drug, Trulicity. This situation sheds light on ongoing issues within pharmaceutical distribution channels and raises questions about compliance and oversight mechanisms necessary to prevent such financial misconduct. Meanwhile, industry dynamics continue to evolve as AbbVie announced workforce reductions in its Allergan Aesthetics unit. This move reflects broader trends where companies streamline operations to prioritize core competencies and promising therapeutic areas. From a regulatory perspective, Maat Pharma's decision to seek re-examination for its graft-versus-host disease medication underscores the iterative nature of drug approval processes. Persistence in addressing regulatory feedback remains crucial as companies strive for successful market entry. In obesity management, Novo Nordisk's oral GLP-1 receptor agonist, Wegovy, gains traction as a convenient treatment option. The shift towards oral medications could significantly improve patient adherence and outcomes by offering an easier alternative to injections. Biogen's decision to terminate its collaboration with Denali Therapeutics after unsuccessful phase 2 trials for a Parkinson's disease candidate highlights the inherent risks in neurological drug development. Rigorous clinical evaluation remains essential to ensure efficacy before advancing therapies further. Despite these advancements, challenges persist as Biogen and Denali's BIIB122 failed in phase 2b trials for idiopathic Parkinson's disease. This underscores the complexity of neurological disorders and emphasizes the need for continued innovation targeting LRRK2 kinase inhibitors. In the realm of CAR-T therapies, Novartis' T-Charge platform faces competition from emerging in vivo technologies. This competitive landscape demonstrates rapid evolution within cell therapy domains, aiming to enhance efficacy and accessibility for patients. Meanwhile, strategic mergers and acquisitions continue as Liminatus Pharma acquires CAR-T biotech Innocsai for $320 million, underscoring sustained interest in oncology cell therapies. Switching gears to Eli Lilly's recent Phase 3 TRIUMPH-1 trial results for retatrutide, they reveal promising weight loss outcomes comparable to bariatric surgery. As a triple hormone receptor agonist targeting GLP-1, retatrutide holds significant potential in addressing obesity—a condition with profound public health implications. Medtronic's acquisition of SPR Therapeutics to enhance its chronic pain portfolio reflects a focus on minimally invasive treatments. Financially, Research Alliance III raised $75 million through a SPAC IPO targeting mergers with China-based biotech firms, signaling increased global collaboration within the sector. Dandelion Health's $14 million Series A funding aims to advance clinical intelligence platforms that could transform drug development through data analytics. Finally, Moderna's mRNA-based flu vaccine is set for review by the FDA's vaccine advisory committee after overcoming initial regulatory hurdles. This scrutiny highlights ongoing challenges faced by novel vaccine technologies within rigorous regulatory environments. In summary, these developments illustrate an industry at the forefront of scientific innovation while grappling with regulatory complexities and operational challenges. From antibody-drug conjugates and immunotherapy combinations to gene editing and advanced cell therapies, there's a clear commitment to improving patient outcomes through novel scientific approaches. As these trends evolve, they promise to redefine treatment landscapes across various therapeutic areas—offering new opportunities for scientific advancements and enhanced patient care worldwide.Support the show

Translating Aging
Beyond senolytics: senoadaptive drugs & clinical data on GPX4 modulation (Dr. Marco Quarta, Rubedo)

Translating Aging

Play Episode Listen Later May 20, 2026 46:37


Marco Quarta is co-founder and Chief Scientific Officer of Rubedo Life Sciences, a precision-therapeutics company developing medicines that target the pathological cell states that drive age-associated disease. Marco's first appearance on the show was three years ago, in February 2023 (Episode 35), when Rubedo was a much earlier-stage company committed to the then-contrarian premise that "the senescent cell" is not a single entity but a heterogeneous family of cell states that needs to be deconvoluted at the single-cell level. In March 2026, Rubedo reported preliminary Phase 1b/2a clinical data for its lead candidate, RLS-1496, a first-in-class topical GPX4 modulator. Marco returns to the show to discuss what survived contact with human biology.In this episode, Chris and Marco unpack the readout from Rubedo's basket trial across four skin indications — psoriasis, atopic dermatitis, actinic keratosis, and photoaged skin — and the biology that underlies it. RLS-1496 came clean on safety in all four indications, with significant efficacy signals despite small patient numbers and short (20–30 day) treatment courses. More provocatively, the clinical and translational data have pushed Marco to redefine what kind of drug this actually is. Rather than a next-generation senolytic, GPX4 modulation appears to act as a state-gating intervention: it triggers ferroptosis in deeply senescent cells that have already crossed a redox threshold, while inducing a hormetic "redox reset" in stressed-but-recoverable cells that restores them to a healthier state. Marco proposes a new category to capture this dual action — adaptive senotherapeutics, or senoadaptive drugs — distinct from senolytics and senomorphics.The conversation traces the arc from Rubedo's founding thesis to a clinically validated platform (ALEMBIC, the AI-enabled single-cell multiomics engine that surfaced GPX4 as a target), through the strategic logic of leading with skin, into the broader question every longevity-biotech founder eventually has to answer: when does a disease-by-disease franchise become a credible preventive geroscience platform? Marco lays out the GLP-1 analogy explicitly — an anchor indication and a label-expansion roadmap that could carry GPX4 modulation from dermatology into respiratory, neurodegenerative, and metabolic disease, and ultimately into the use case where biomarkers of cellular senescence flag patients for therapy decades before disease becomes clinically apparent.The Finer Details:How Marco's 2023 contrarian view — that "senescent cells" hide a tissue- and state-specific reality — has been reinforced by the clinic, and how Rubedo's framing has shifted from "targeting senescent cells" to "targeting pathological cell states"The biology of GPX4 as a lipid-peroxidation gatekeeper, why senescent cells have intrinsic vulnerabilities (p16, p21, CDK4/6 inhibition) that make them ferroptosis-sensitive, and how Rubedo's approach differs from oncology-focused GPX4 programs at Takeda and othersThe "senoadaptive" mechanism — RLS-1496 eliminates GPX4-dependent senescent cells via ferroptosis while triggering NRF2/Keap1-driven redox reset, autophagy, and epigenetic remodeling in recoverable cells, restoring tissue trajectory from degenerative to regenerativeWhy Rubedo led with skin: clean regulatory path, accessible tissue, the ability to read out aging biology anddisease in the same trial, and a label-expansion runway into systemic indicationsPhase 1b (Europe) and Phase 2a (US) basket-trial results across psoriasis, atopic dermatitis, photoaged skin, and actinic keratosis: clean safety in 4/4 indications and significant efficacy signals — itch reduction in atopic dermatitis, decreased lesional thickness in psoriasis, target-engagement-correlated clinical improvement in photoaged skinThe richness of the translational dataset: biopsies, tape-stripping, spatial transcriptomics, proteomics, multiplex histomics, plasma biomarkers — all feeding back into ALEMBIC to refine the platformWhy actinic keratosis is the most strategically important indication — an age-related, chronic-inflammatory, precancerous condition where Rubedo can simultaneously test disease modification and biological-age reversalThe Rubedo–Beiersdorf partnership and the cosmetic vertical as a parallel commercial axisPipeline beyond skin: targeting aberrant basaloid stem cells in IPF and other pulmonary indications using different modalities (prodrugs, PROTACs, ADCs) to achieve cell-state selectivityThe longer-arc vision: senescence biomarkers as a "prediabetes-style" early signal, with senoadaptive drugs deployed decades before disease — and what a GLP-1-scale franchise might look like for GPX4 modulationQuotes:"There is not such a thing as a senescent cell — like there is not a cancer cell. And that was the initial idea. I'm glad that over time the field evolved. Now this is an accepted concept in the senotherapeutic space.""We are really talking about a dual function of RLS-1496 that can modulate the cell state depending on the adaptive response. That's why we call this — de facto — a new class of senotherapeutics. We call them adaptive senotherapeutics, or senoadaptive drugs — not a senolytic or a senomorphic, but working by modulating the cell state.""The best animal model for human therapies is human. As much as you can do preclinical work in animal models, it's always an approximation. We were able to test this directly in patients for safety, and in 4 out of 4 indications, we didn't have any safety signal.""Imagine you're taking care of a growing tree, and this tree has some dead leaves and some are a little bit stressed. If you shake the tree, the dead leaves will fall; the healthy leaves will not, because they're healthy and they resist the shake. But that shake actually gives the stressed leaves space and breathing room, and helps them to regain vitality. That's a little bit what GPX4 modulation does.""Senotherapeutics is a large, growing field — an untapped therapeutic opportunity. There is no such thing as a pan-senolytic or a pan-senotherapeutic, like there is no pan-oncotherapeutic. You need to understand the context. But these will all be part of the arsenal for true longevity medicine.""I don't see this as prevention of disease. The way I see therapies like ours, and the way the field of longevity is developing, is treating diseases decades before they develop. That's not a new concept — that's what we're doing in diabetes. You can be diagnosed with prediabetes today and reverse those biomarkers with lifestyle changes or metformin, and maybe never develop diabetes. That's exactly what we're doing here.""First of all, celebrating the first approved drugs from Rubedo — I don't think we're too far from that. But that's also a beginning, because you learn from the big momentum the GLP-1 agonists created: how a drug can start in one indication, create a new field, and prove that you can go beyond that. I hope in a few years we come back and talk about the next GLP-1 — this could be GPX4 modulators, or the senoadaptive drugs that are first in our pipeline."Links:Rubedo Life Sciences: https://www.rubedolife.comMarco Quarta's previous appearance on Translating Aging: Ep 35 — Targeting Pathologic Cells to Preserve Biological Youth

CME in Minutes: Education in Primary Care
Expanding the Use of HER2-Directed ADCs Into Early-Stage Breast Cancer: Multidisciplinary Conversations on (Neo)Adjuvant Care

CME in Minutes: Education in Primary Care

Play Episode Listen Later May 20, 2026 61:07


Please visit answersincme.com/860/101385133-replay to participate, download slides and supporting materials, complete the post test, and get a certificate. Presented by Peter A. Fasching, MD; Michael Gnant, MD, FACS; and Cristina Saura Manich, MD, PhD. In this activity, experts in breast cancer discuss new evidence in neoadjuvant and adjuvant care of early disease. Upon completion of this activity, participants should be better able to: Describe multidisciplinary viewpoints on the role that HER2-directed ADCs may play in the (neo)adjuvant setting for HER2-positive early-stage breast cancer; Evaluate evidence for the (neo)adjuvant use of HER2-directed ADCs in the multidisciplinary management of HER2-positive early-stage breast cancer; and Formulate evidence-based multidisciplinary strategies to optimally incorporate (neo)adjuvant HER2-directed ADCs into the treatment paradigm for HER2-positive early-stage breast cancer.

The MM+M Podcast
ASCO 2026: What you need to know before the data drops, a podcast sponsored by BGB Group

The MM+M Podcast

Play Episode Listen Later May 20, 2026 16:32


Before the full datasets arrive, the signals are already there for those who know how to read them. Ben Murray, associate medical director at BGB Group, offers an expert preview of ASCO 2026, covering bispecifics, ADCs, earlier-stage treatment shifts and progress in historically difficult-to-treat tumors. Check us out at: mmm-online.com   Follow us:  YouTube: @MMM-online TikTok: @MMMnews Instagram: @MMMnewsonline Twitter/X: @MMMnews LinkedIn: MM+M   To read more of the most timely, balanced and original reporting in medical marketing, subscribe here. Music: “Deep Reflection” by DP and Triple Scoop Music. Hosted by Simplecast, an AdsWizz company. See https://pcm.adswizz.com for information about our collection and use of personal data for advertising.

BioCentury This Week
Ep. 367 - FDA, obesity targets and the rise of DACs

BioCentury This Week

Play Episode Listen Later May 19, 2026 30:40 Transcription Available


Marty Makary wasn't the only official on the outs at FDA last week in another tumultuous turn of events for the regulatory agency. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses who's in, who's out and what's next at FDA — and why the changes may mean more conservative decision-making at the agency in the near term.BioCentury's analysts also discuss the new obesity targets that came to light at last week's annual meeting of the European Congress on Obesity, the market for biotech IPOs, and the emergence of degrader-antibody conjugates. DACs pair the tissue-targeting logic of antibody-drug conjugates (ADCs) with the catalytic activity of protein degraders. 3C Therapeutics is the latest entrant to the field, pitching its TriCore platform as a modular backbone for DAC generation. This episode of the BioCentury podcast is brought to you by Jeito Capital.View full story: https://www.biocentury.com/article/659510#FDA #ObesityDrugDevelopment #BiotechIPO #DACs #Biopharma00:01 - Sponsor Message: Jeito Capital 02:53 - FDA Leadership Shakeup10:35 - Obesity Target Hunt16:07 - Biotech IPOs20:02 - Degrader-antibody Conjugates28:42 - Serif: Non-viral DNATo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Pharma and BioTech Daily
Regeneron $2.3B Deal & FDA Shake-Up | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later May 19, 2026 4:52


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The industry is currently navigating a pivotal era marked by a blend of scientific innovation, regulatory shifts, and intriguing clinical trial results. A key regulatory upheaval unfolds as the FDA faces leadership changes. The recent departures of key figures from both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) underscore a period of uncertainty. With former commissioner Marty Makary stepping down, concerns arise about how these changes might affect drug approvals and regulatory guidance at such a crucial time in the industry. Turning to clinical trials, Regeneron has experienced a setback as its lag-3 inhibitor failed to surpass Merck's Keytruda in phase 3 melanoma studies. This marks Regeneron's second significant late-stage failure within a year, prompting analysts to reassess its strategic direction in oncology. In parallel, Regeneron has inked a $2.3 billion agreement with Parabilis Medicines to develop an advanced antibody-drug conjugate (ADC)-like therapy. The goal is to enhance targeting capabilities by improving binding to complex target sites, which could revolutionize ADC technology. Similarly, BioMarin's substantial investment in Inozyme's enzyme replacement therapy faced hurdles after falling short on one of two primary endpoints in a phase 3 trial for a rare genetic disorder. Such outcomes highlight the inherent risks and high stakes involved in late-stage drug development. Yet, innovation continues to drive progress. Vincentage Pharma's oral GLP-1 agonist has demonstrated a promising mean weight loss of 12.4% over a year, positioning it as a competitor to Eli Lilly's Orforglipron in the burgeoning Chinese market. This reflects the global pursuit to harness GLP-1 receptor agonists in tackling metabolic disorders and obesity. Ipsen has made strides with its long-acting neurotoxin for aesthetic applications, advancing into phase 3 trials following encouraging phase 2 results that showed significant improvements in frown lines lasting up to 24 weeks post-treatment. This progress suggests robust competition against established players like Botox. Meanwhile, Merck and Kelun-Biotech have successfully completed a phase 3 trial with their trop2-directed ADC sacituzumab tirumotecan (SAC-TMT) for endometrial cancer, achieving primary endpoints and paving the way for further regulatory submissions. Such advancements emphasize ADC technology's growing importance in oncology therapeutics. Broad industry trends reflect strategic investments, exemplified by Boston Scientific's $1.5 billion investment in Mirus and an option to acquire its transcatheter aortic valve replacement system—highlighting continued interest in high-growth medtech sectors. In another notable development, Daiichi Sankyo and AstraZeneca have reached a milestone with their ADC Enhertu, securing dual FDA approvals for early breast cancer treatment. These approvals underscore Enhertu's potential to expand treatment options for patients at an early disease stage, potentially altering standard treatment protocols. On the regulatory front, AstraZeneca has secured FDA approval for baxdrostat—an aldosterone synthase inhibitor developed through its acquisition of CinCor Pharma—demonstrating strategic investment in innovative cardiovascular therapies aligned with ambitious revenue goals. However, challenges persist as demonstrated by Amgen's Tavneos being linked to fatalities across Japan and the U.S., raising significant concerns about data integrity and pharmacovigilance. In contrast, Revolution Medicines' RAS inhibitor doubled survival rates in phase 3 pancreatic cancer trials. This breakthrough positions Revolution as an emerging leader in oncology therapeutics amidst fierce competition from companies aiming to improve drug tolerability and extend survival benefits. These narratives paint a picture of an industry poised for transformation—balancing scientific breakthroughs against regulatory challenges and financial pressures. As therapeutic modalities evolve—from oral biologics to advanced ADCs—the sector is set on course for substantial impacts on patient care and drug development pipelines. In summary, the pharmaceutical and biotech industries' focus on advancing therapeutic options through scientific innovation while navigating complex regulatory landscapes underscores an ongoing commitment to addressing unmet medical needs through new drug classes and targeted therapies. These efforts highlight trends toward personalized medicine and precision oncology that are likely to shape future trajectories in these dynamic fields.Support the show

Empowered Patient Podcast
Next Generation Bispecific Antibody Drug Conjugates Improves Targeting of Solid Tumors with Dr. Mayank Gandhi NEOK Bio

Empowered Patient Podcast

Play Episode Listen Later May 14, 2026 20:28


Dr. Mayank Gandhi, CEO of NEOK Bio, discusses the company's work on bispecific antibody drug conjugates and the limitations of conventional ADCs, which target a single antigen. Using a bispecific antibody to target two unique antigens on a tumor can address the shortcomings of earlier approaches by improving delivery of the toxic payload, overcoming tumor heterogeneity, and reducing off-target toxicity.  NEOK has drugs in development for prostate cancer, and lung, head, neck, and gastrointestinal tumors. The trend for ADCs is toward multi-specific and multi-payload drugs, though Mayank warns it is not a simple task to go from one to many in designing these drug conjugates. Mayank explains, "There have been a lot of advancements in the last couple of decades, and especially the last few years, in various modalities in the treatment of hematological cancers, as well as to a certain degree in solid tumors. However, for many, many solid tumors, there's still a high unmet need given the still significant outcome, poor outcomes that patients experience, particularly with patients having metastatic disease across a variety of solid tumors. Now, if you look at specific modality like ADC or antibody drug conjugates, which is where NEOK Bio is, there's been a renaissance, if you will, with this modality in the last five to six years, particularly after the approval of a drug called Enhertu, which targets HER2 mutation. Now, many ADCs have been approved with different payloads. And so definitely that's made a dent in a variety of tumors, particularly in hematological cancers and select solid tumors as well."   "Conventional ADCs thus far target one antigen or one target on a tumor. So it's an antibody-based approach. The antibody is typically pursuing one specific antigen that's usually an antigen that's expressed on tumors selectively versus normal tissue or normal cells. And then you have a linker and a payload, usually a toxic payload that's conjugated via a linker to the antibody. So that's an antibody drug conjugate construct."   "Thus far, all the ADCs approved have been targeting only one antigen with a couple of different payloads. And so our bispecific approach is targeting two different antigens. If we use a bispecific antibody that targets two unique antigens on the tumor, we have more than one place that a potential antibody can bind and deliver the toxic payload. And then we have made some very significant improvements or changes in the antibody itself." #NEOKBio #DrugDevelopment #Innovation #AntibodyDrugConjugates #ADC #Oncology #Biotech#Oncology #SolidTumors #BispecificADC #CancerResearch #TranslationalResearch #MedicalOncology #HematologyOncology #ClinicalTrials #Biotech #Pharma #DrugDevelopment #PrecisionOncology #TumorMicroenvironment #TargetedTherapy NEOKBio.com Download the transcript here

Empowered Patient Podcast
Next Generation Bispecific Antibody Drug Conjugates Improves Targeting of Solid Tumors with Dr. Mayank Gandhi NEOK Bio TRANSCRIPT

Empowered Patient Podcast

Play Episode Listen Later May 14, 2026


Dr. Mayank Gandhi, CEO of NEOK Bio, discusses the company's work on bispecific antibody drug conjugates and the limitations of conventional ADCs, which target a single antigen. Using a bispecific antibody to target two unique antigens on a tumor can address the shortcomings of earlier approaches by improving delivery of the toxic payload, overcoming tumor heterogeneity, and reducing off-target toxicity.  NEOK has drugs in development for prostate cancer, and lung, head, neck, and gastrointestinal tumors. The trend for ADCs is toward multi-specific and multi-payload drugs, though Mayank warns it is not a simple task to go from one to many in designing these drug conjugates. Mayank explains, "There have been a lot of advancements in the last couple of decades, and especially the last few years, in various modalities in the treatment of hematological cancers, as well as to a certain degree in solid tumors. However, for many, many solid tumors, there's still a high unmet need given the still significant outcome, poor outcomes that patients experience, particularly with patients having metastatic disease across a variety of solid tumors. Now, if you look at specific modality like ADC or antibody drug conjugates, which is where NEOK Bio is, there's been a renaissance, if you will, with this modality in the last five to six years, particularly after the approval of a drug called Enhertu, which targets HER2 mutation. Now, many ADCs have been approved with different payloads. And so definitely that's made a dent in a variety of tumors, particularly in hematological cancers and select solid tumors as well."   "Conventional ADCs thus far target one antigen or one target on a tumor. So it's an antibody-based approach. The antibody is typically pursuing one specific antigen that's usually an antigen that's expressed on tumors selectively versus normal tissue or normal cells. And then you have a linker and a payload, usually a toxic payload that's conjugated via a linker to the antibody. So that's an antibody drug conjugate construct."   "Thus far, all the ADCs approved have been targeting only one antigen with a couple of different payloads. And so our bispecific approach is targeting two different antigens. If we use a bispecific antibody that targets two unique antigens on the tumor, we have more than one place that a potential antibody can bind and deliver the toxic payload. And then we have made some very significant improvements or changes in the antibody itself." #NEOKBio #DrugDevelopment #Innovation #AntibodyDrugConjugates #ADC #Oncology #Biotech#Oncology #SolidTumors #BispecificADC #CancerResearch #TranslationalResearch #MedicalOncology #HematologyOncology #ClinicalTrials #Biotech #Pharma #DrugDevelopment #PrecisionOncology #TumorMicroenvironment #TargetedTherapy NEOKBio.com Listen to the podcast here

Pharma and BioTech Daily
Daiichi Sankyo's $1.3B Oncology Plan & CSL's $5B Setback | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later May 12, 2026 4:40


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into some of the most compelling stories and trends shaping the industry. Daiichi Sankyo has unveiled a bold five-year business plan with an eye on rising to become a top-five global oncology leader by 2035. This ambition is driven by a $1.3 billion initiative focused on antibody-drug conjugates, or ADCs, which are targeted cancer therapies. These plans highlight a strategic emphasis on oncology and operational efficiencies designed to maintain competitive advantage in a rapidly evolving market. Meanwhile, CSL Limited faces a more challenging landscape, adjusting its revenue projections and facing a significant impairment related to its acquisition of Vifor Pharma. These financial challenges underline the risks inherent in large-scale acquisitions within the pharmaceutical sector, necessitating a reassessment of strategic priorities and investments in R&D. Regulatory developments continue to be pivotal, with Partner Therapeutics' bispecific antibody Bizengri gaining FDA national priority designation for rare bile duct cancer. This underscores the FDA's dedication to expediting critical therapies through its National Priority Pilot program, aiming to bring life-saving treatments to underserved populations quickly. However, regulatory uncertainty looms with President Donald Trump's reported plan to dismiss FDA Commissioner Marty Makary, which could impact the agency's leadership and agenda. Additionally, a Supreme Court ruling has temporarily reinstated telemedicine access to mifepristone, an abortion pill, spotlighting the ongoing debates about reproductive healthcare accessibility through telemedicine. In research news, Novo Nordisk's collaboration with an AI biotech firm marks a strategic shift aimed at rescuing its Parkinson's cell therapy program. This partnership highlights the increasing role of artificial intelligence in drug development, particularly for revitalizing stalled projects using advanced technological applications. On the clinical trial front, Inhibrx's midphase results are promising for their OX40 agonist combined with Merck's Keytruda, showing doubled response rates in cancer patients. Such advancements underscore the potential of combination therapies in oncology and are likely to draw more investment interest from major players like Merck. Amgen's investment in a quantum technology firm poised for an IPO represents another exciting frontier. The application of quantum computing in drug discovery could revolutionize computational biology by accelerating therapeutic discoveries and improving precision medicine approaches. The biotech sector is also seeing financial maneuvers with quantum tech firms planning IPOs following investments from companies like Amgen. This signals a growing interest in leveraging quantum technology for breakthroughs in drug discovery. In Alzheimer's research, a novel gene therapy study presents an innovative method for clearing amyloid plaques from mouse brains without crossing the blood-brain barrier. By sending a protective gene to the liver, researchers achieved systemic plaque clearance—an approach that could revolutionize treatment strategies if successful in human trials. A new development in diagnostics involves a blood test predicting patient responses to GLP-1 receptor agonists like Ozempic and Wegovy. As these drugs become popular for weight management, such diagnostics could optimize outcomes by identifying patients most likely to benefit. Omada Health reported a 42% revenue increase in Q1, reflecting the expanding digital health solutions market. Their collaboration with Eli Lilly's employer weight loss program indicates rising demand for comprehensive health strategies integrating pharmacotherapy and digital health platforms. Overall, thSupport the show

Pharma and BioTech Daily
Gilead Projects $1B YezTugo Sales | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later May 11, 2026 5:37


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today's episode delves into a range of significant industry updates, spotlighting scientific advancements, regulatory challenges, and strategic movements that are shaping the future of drug development and patient care. The pharmaceutical landscape is often marked by rapid changes, as evidenced by recent reports indicating President Donald Trump's plan to dismiss FDA Commissioner Marty Makary. This potential leadership change is set against a backdrop of controversies during Makary's tenure, including the rejection of Replimune's advanced melanoma therapy, RP1. This therapy was designed as an oncolytic immunotherapy using a genetically modified herpes simplex virus to target and destroy cancer cells. The FDA's rejection of RP1 ignited debate over the agency's decision-making processes, which some critics view as inconsistent and lacking transparency. Such decisions can have profound implications—delaying patient access to critical treatments and affecting company financials and market dynamics. Furthermore, internal discord at the FDA during Makary's leadership period underscores the importance of stable leadership in maintaining efficiency and fostering scientific rigor. Turning to corporate developments, Gilead Sciences has revised its first-year sales forecast for YezTugo, its long-acting PrEP injection for HIV prevention. The company now projects revenues to reach $1 billion, reflecting strong market uptake. This adjustment highlights the growing demand for innovative PrEP solutions as part of broader HIV prevention strategies. Meanwhile, Daiichi Sankyo is grappling with a $610 million profit setback due to an overextension in their manufacturing capabilities for antibody-drug conjugates (ADCs). This situation illustrates the financial risks inherent in scaling production within rapidly evolving therapeutic areas like ADCs, where balancing supply and demand remains critical. In legal news, Capricor Therapeutics has initiated a lawsuit against NS Pharma concerning a breach-of-contract over Deramiocel, a Duchenne muscular dystrophy treatment. With an FDA decision pending, this legal battle underscores the complexities of partnerships and contract compliance in advancing neuromuscular therapies. On the regulatory front, Biogen and Eisai are experiencing delays from the FDA regarding their Alzheimer's drug Leqembi. These regulatory hurdles highlight the complex processes that can impact drug rollout timelines significantly. Odyssey Therapeutics' successful $304 million IPO aims to bolster its autoimmune and inflammatory disease pipeline. This reflects robust investor interest in biotech firms with promising therapeutic candidates addressing high-need areas. In terms of market dynamics, the competition between Novo Nordisk's Wegovy pill and Eli Lilly's Foundayo is reshaping the oral GLP-1 receptor agonist market. A newly launched weekly tracker will monitor prescription trends to provide insights into how these weight-loss solutions are impacting obesity management. Additionally, Johnson & Johnson's efforts to enhance awareness around depression treatment through public health campaigns illustrate how companies are addressing mental health challenges. Advancements in digital health continue with Tether's rollout of medical AI for mobile devices and MedAptus' operational 'command center,' highlighting ongoing innovations poised to transform healthcare delivery by enhancing efficiency and patient engagement. Strategic acquisitions remain a key theme as Angelini Pharma acquires Catalyst Pharmaceuticals for $4.1 billion—a move that expands Angelini's footprint into the U.S. rare neurological drug market. Similarly, Blackstone's $250 million investment in Anagram Therapeutics for cystic fibrosis enzyme replacement therapySupport the show

OncLive® On Air
S17 Ep12: ADCs Change Treatment Paradigms and Challenge Standard AE Management Protocols in TNBC: With Sara Nunnery, MD, MSCI; and Irene Morae Kang, MD

OncLive® On Air

Play Episode Listen Later Apr 30, 2026 47:23


Breast Cancer Briefing, hosted by Sara Nunnery, MD, MSCI, a breast medical oncologist and the director of Breast Cancer Research at Tennessee Oncology in Nashville, is a podcast series that breaks down the latest news in breast cancer research, one conversation at a time.In part 2 of this conversation, filmed live onsite at the 43rd Annual Miami Breast Cancer Conference, Dr Nunnery sat down with Irene Morae Kang, MD, an assistant professor in the Department of Medical Oncology & Therapeutics Research and the medical director of Women's Health Medical Oncology at City of Hope Orange County in Irvine, California.Their discussion focuses on the rapidly evolving treatment paradigm for first-line metastatic triple-negative breast cancer (TNBC), including the emergence of new data that is shifting standards of care. Dr Kang explained that TNBC is defined by the absence of estrogen, progesterone, and HER2 receptors, which historically restricted treatment options to non-targeted chemotherapy. A primary focus of the conversation was the role of PD-L1 expression and the use of immunotherapy. Dr Kang described PD-L1 as a checkpoint inhibitor protein on cancer cells that shuts off the immune system. By blocking this protein, oncologists can keep the body's T-cells vigilant to fight the cancer. However, she noted that immunotherapy is typically reserved for the approximately 40% of patients who express PD-L1 and may be contraindicated for those with active autoimmune diseases or a history of severe immune-related toxicities.The dialogue transitioned into the use of antibody-drug conjugates (ADCs). Dr Kang reviewed data from major trials using TROP2-targeting ADCs in the first-line setting. Dr Kang emphasized the importance of using these highly effective agents early, as many patients with TNBC do not survive to receive a second line of therapy.Finally, Dr Kang highlighted the distinct toxicity profiles and administration schedules that guide clinical decision-making. Although sacituzumab govitecan-hziy (Trodelvy) is frequently associated with neutropenia and alopecia, the primary toxicities associated with datopotamab deruxtecan-dlnk (Dato-DXd; Datroway) are stomatitis and ocular adverse effects like dry eye. Using Dato-DXd in practice requires a rigorous prophylactic regimen, including steroid mouthwash and lubricating eye drops. Ultimately, Dr Kang noted that because efficacy appears similar between the 2 ADCs, the choice often rests on the patient's lifestyle, their ability to adhere to preventative AE protocols, and infusion schedule preference.

Pharma and BioTech Daily
Eli Lilly's $7B Kelonia Buy Boosts CAR-T Tech | Pharma and Biotech Daily

Pharma and BioTech Daily

Play Episode Listen Later Apr 21, 2026 5:10


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of pivotal advancements and strategic moves that are reshaping the landscape of drug development and patient care. In vaccine development, Sanofi has recently reported promising results from a comparative trial of its protein-based COVID-19 vaccine, Nuvaxovid, against Moderna's latest mRNA vaccine, MNEXspike. The focus here was primarily on tolerability, and Sanofi's candidate demonstrated a superior safety profile. This marks a significant moment in the ongoing evolution of vaccine technology, underscoring the importance of diversifying vaccine platforms to effectively address global public health challenges. Shifting to regulatory landscapes, the U.S. Food and Drug Administration has been tasked with expediting the review process for psychedelic drugs under a directive from former President Donald Trump. This move aims to enhance access to novel treatments for serious mental health conditions, reflecting a broader trend in medicine towards exploring therapeutic avenues beyond traditional pharmaceuticals. It highlights an increasing openness to alternative therapies that could potentially transform mental health care. Strategic acquisitions continue to fuel innovation within the sector. Eli Lilly's acquisition of Kelonia Therapeutics for up to $7 billion is particularly noteworthy. This investment marks Lilly's second venture into in vivo CAR-T technology this year, emphasizing its commitment to advancing cell-based therapies. Kelonia's work on phase 1-stage myeloma therapy showcases the potential of CAR-T modalities in treating complex diseases, promising expanded treatment options for patients. Globally, infrastructure development is gaining momentum with Biovac securing a $108 million finance package to establish Africa's first fully integrated vaccine production facility. This initiative is crucial for enhancing regional healthcare autonomy by addressing local health needs and reducing reliance on external supply chains—a step forward in building resilient healthcare systems. In oncology, Merck & Co. has unveiled clinical data for its PD-1xVEGF bispecific antibody in non-small cell lung cancer (NSCLC). The results reveal similar efficacy and safety profiles compared to existing treatments, suggesting promising prospects for this bispecific approach in oncology therapeutics. Bispecific antibodies are engineered to engage two different targets simultaneously, potentially enhancing anti-tumor efficacy by not only stimulating immune responses but also disrupting angiogenesis. This innovation represents a continued focus on targeted cancer therapies that enhance treatment precision. Similarly, AstraZeneca's IL-33 inhibitor has achieved another phase 3 success in treating chronic obstructive pulmonary disease (COPD). This reinforces the therapeutic potential of targeting interleukin pathways in inflammatory diseases and reflects AstraZeneca's strategic focus on respiratory conditions. Such successes highlight the promise of precision medicine in improving patient outcomes. On the topic of market expansion, GlaxoSmithKline's multiple myeloma treatment Blenrep has entered the Chinese market. This move exemplifies the growing importance of global market access strategies, ensuring that patients worldwide can benefit from cutting-edge therapies. Now let's turn our attention to some intriguing scientific developments. A former Genentech leader has launched a synthetic design lab focused on adaptive "smart" antibody-drug conjugates (ADCs) for cancer therapy. ADCs represent a significant leap forward in precision medicine by offering targeted cancer treatments that minimize damage to healthy cells. These "smart" ADCs could provide more effective and less toxic options for cancer patients. Support the show

Pharma and BioTech Daily
AI Integration and Regulatory Shifts in Pharma

Pharma and BioTech Daily

Play Episode Listen Later Apr 16, 2026 6:03


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're exploring a fascinating realm where technology and biology converge, starting with a deepening relationship between biopharma and artificial intelligence. Novartis CEO Vas Narasimhan's recent appointment to the board of AI company Anthropic signals the strategic integration of AI into drug discovery and development processes. This collaboration highlights a growing trend where pharmaceutical companies are increasingly leveraging AI to optimize clinical trials, streamline drug discovery, and personalize patient care strategies. Similarly, Novo Nordisk has announced a strategic partnership with OpenAI to integrate AI technologies across various facets of its operations, including drug discovery and manufacturing. By leveraging OpenAI's machine learning capabilities, Novo Nordisk aims to streamline research efforts and accelerate therapeutic identification—a collaboration reflecting AI's growing role as an essential tool for maintaining competitiveness in drug development. Additionally, Amazon Web Services' launch of the Amazon Bio Discovery AI tool marks another milestone. Designed to expedite antibody design and drug discovery processes, it provides researchers with robust AI-driven platforms enhancing therapeutic design speed and accuracy. The emphasis on monoclonal antibodies aligns with industry trends focusing on targeted therapies for diseases such as cancer. Meanwhile, Eli Lilly's new obesity treatment, Foundayo, has caught the FDA's attention due to potential safety concerns. Despite progressing with its launch, the FDA has requested additional safety information to address unexpected serious risks associated with the drug. This highlights the ongoing regulatory scrutiny that accompanies novel treatments, especially in areas like obesity where patient populations are large and diverse. In another strategic move, Eli Lilly's acquisition of Crossbridge Bio for up to $300 million aims to bolster its oncology pipeline with dual-payload antibody-drug conjugates (ADCs). This acquisition reflects a strategic move enhancing Eli Lilly's position in oncology by integrating cutting-edge ADC technologies known for delivering cytotoxic agents directly to cancer cells while minimizing off-target effects. On another front, Travere Therapeutics is mapping a pathway to a potential $3 billion opportunity in the U.S. market following significant approval for its treatment Filspari, targeted at rare kidney diseases. This approval underscores the increasing focus on rare diseases, which present lucrative opportunities for pharmaceutical companies due to significant unmet needs and often high-cost treatments. Astellas' manufacturing strategy underscores the importance of reliable supply as a critical bridge from research to patient care. Led by Chief Manufacturing Officer Rao Mantri, this strategy highlights how manufacturing excellence can significantly impact drug availability and patient outcomes. It emphasizes that production reliability is vital in ensuring groundbreaking research translates into accessible medical treatments. In contrast, a slowdown in IPOs has been noted amidst an aggressive merger and acquisition spree by major pharmaceutical companies. This consolidation trend reflects strategic shifts within the industry as companies seek to bolster pipelines through acquisitions rather than organic growth. Such dynamics indicate a strategic pivot as firms prioritize acquiring promising assets over developing them from scratch. Ionis Pharmaceuticals' recent win in a drug naming competition exemplifies the complexities involved in branding within the pharmaceutical sector. Crafting a drug name that is memorable yet distinctive involves balancing marketability with regulatory requirements—a reflection of the intSupport the show

Keeping Current CME
Up Front Antibody-Drug Conjugates: Shifting the Paradigm in Metastatic Triple-Negative Breast Cancer Treatment

Keeping Current CME

Play Episode Listen Later Apr 9, 2026 38:51


Did you know that antibody-drug conjugates (ADCs) targeting Trop2 have demonstrated significant clinical potential for patients with TNBC? Credit available for this activity expires: 4/8/27 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/front-antibody-drug-conjugates-shifting-paradigm-metastatic-2026a1000a9z?ecd=bdc_podcast_libsyn_mscpedu

7 Minute Security
7MS #716: Tales of Pentest Pwnage – Part 83

7 Minute Security

Play Episode Listen Later Apr 3, 2026 33:23


Today is my favorite pentest pwnage tale of 2026 – and maybe ever!  It centers around an ADCS abuse via an attack path I'd never seen before.  Tips include: Use Netexec to pull Powershell history Trying to steal reg hives and the EDR is made?  Try copying them out to some-other-server.domain.comshare This post featured interesting use of the Responder -N option

The PQI Podcast
Modern Antibody-drug conjugates and New CINV Challenges

The PQI Podcast

Play Episode Listen Later Mar 26, 2026 35:53


In this episode, we welcome Kirollos Hanna, PharmD, BCPS, BCOP, a recognized leader in oncology pharmacy practice and research. Dr. Hanna shares insights into the evolving landscape of antibody-drug conjugates (ADCs) and the unique challenges they present in managing chemotherapy-induced nausea and vomiting (CINV).  As ADC use expands, oncology teams are observing new and sometimes underrecognized patterns of nausea and vomiting, particularly with HER2-directed therapies and delayed-phase symptoms that extend beyond the traditional monitoring window. This discussion highlights how these patterns differ from conventional chemotherapy and what that means for clinical practice.  Dr. Hanna also reviews emerging pharmacokinetic data and clinical trial evidence supporting the use of NK1 receptor antagonist–based antiemetic strategies. The conversation emphasizes practical, actionable approaches for optimizing supportive care, improving patient quality of life, and ensuring proactive symptom management within the medically integrated oncology team.  Learning Objectives:  Describe emerging patterns of chemotherapy-induced nausea and vomiting (CINV) associated with antibody–drug conjugates (ADCs), with emphasis on HER2-directed ADCs and delayed-phase nausea beyond day 5  Discuss pharmacokinetic and clinical trial evidence on NK1 receptor antagonist–based antiemetic strategies when optimizing CINV prevention for patients receiving ADC therapy.  This episode offers 0.5 CE credit hours to pharmacists and pharmacy technicians. Claim CE credit here. Guest: Kirollos Hanna, PharmD, BCPS, BCOP, Director of Pharmacy, Minnesota Oncology, Assistant Professor of Pharmacy, Mayo Clinic College of Medicine, Associate Editor, Journal of the Advanced Practitioner in Oncology (JADPRO)  Disclosures: Speaker: BeOne, BMS, Exelixis, Pfizer Consulting Fees: BeOne, BMS, Exelixis, Pfizer, Astrazeneca

Jimmy Akin's Mysterious World
Ghost Pets! (Animal After Death Communications, ADCs)

Jimmy Akin's Mysterious World

Play Episode Listen Later Jan 23, 2026 112:52


Do pets reach back after death? Jimmy Akin and Dom Bettinelli assess new scientific studies on animal after-death communications. Can warning apparitions, shared sightings, and sensory details offer evidence for animal life after death? The post Ghost Pets! (Animal After Death Communications, ADCs) appeared first on StarQuest Media.