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Highlights from the PER® CME activity "Current Approaches and Future Directions for Early-Stage TNBC" — 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, experts Nour Abuhadra, MD, and Antonio Giordano, MD, PhD, discuss the emerging role of antibody-drug conjugates (ADCs) in early-stage triple-negative breast cancer (TNBC) and the practice implications of ongoing post-neoadjuvant trials.Earn CME credit by completing the full accredited activity (available through July 31, 2027): https://www.gotoper.com/courses/current-approaches-and-future-directions-for-early-stage-tnbcThis 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 an educational grant from 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.
In this podcast episode, BJ Rimel, MD, and Elizabeth Lee, MD, discuss the scientific rationale for targeting CDH6 in ovarian cancer and the emerging role of CDH6-directed antibody–drug conjugates (ADCs) in platinum-resistant disease, including:CDH6 biology, expression patterns, and its potential as a therapeutic target in ovarian cancerEarly-phase efficacy data with investigational CDH6-directed ADCs, including raludotatug deruxtecan (R-DXd) and CUSP06, and an ongoing phase III trial of R-DXdSafety considerations with CDH6-directed ADCs, including cytopenias, gastrointestinal toxicities, fatigue, and interstitial lung disease/pneumonitisConsiderations for sequencing ADCs, including the potential impact of target expression, payload class, and mechanisms of resistancePresenters:BJ Rimel, MDDivision Chief, Gynecologic OncologyProfessor, Department of OB/GYNUniversity of WashingtonClinical Director of Gynecologic OncologyFred Hutchinson Cancer CenterSeattle, WashingtonElizabeth Lee, MDDivision of Gynecologic OncologyCenter for Cancer Therapeutic InnovationDepartment of Medical OncologyDana-Farber Cancer InstituteBoston, MassachusettsLink to full program: https://bit.ly/3SqCAZ6Get access to all of our new podcasts by subscribing to the Decera Clinical Education Podcast on Apple Podcasts, YouTube Music, or Spotify. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
Next-generation complex conjugates, such as peptide conjugates, radioconjugates, ligand-conjugated antisense medicines, and small-molecule drug conjugates, are expected to outpace growth comparative antibody drug conjugates (ADCs), which are still slated for strong growth. Gaurav Chaudhary, CEO, Roots Analysis, a business intelligence firm serving the bio/pharmaceutical industry, provides the latest market analysis of these next-generation complex conjugates and ADCS. Support the show
China has rapidly emerged as one of the most important sources of biotech innovation in the world. But what is driving that growth—and what does it mean for U.S. biotech companies, pharmaceutical companies and investors?In this episode of the Asia Business Podcast, Art Dicker speaks with David Cao, founder of Target2Drug BioAdvisory and a strategic advisor to VCs, biotech startups and biopharma companies. David has spent his career across both the U.S. and Chinese life sciences ecosystems and helps companies navigate opportunities between the two markets.David explains why China's biotech rise is the result of decades of investment in scientific talent, research infrastructure and drug-development capabilities—not an overnight phenomenon. They discuss China's particular strengths in drug discovery and early-stage clinical development, including why trials can often move faster and at lower cost in China.The conversation also explores the surge in China-to-U.S. biotech licensing, the growing importance of Chinese-developed ADCs and bispecific antibodies, and the rise of the “NewCo” model, in which U.S. investors build new biotech companies around assets sourced from China. David explains why Chinese biotech companies increasingly want more than a traditional licensing payment—they may also want equity, board participation and the opportunity to learn how global drug development works.Art and David also examine an underappreciated opportunity for Western biotech companies: conducting clinical development in China, particularly for rare diseases where the concentration of patients at major Chinese hospitals can dramatically accelerate recruitment.Finally, they tackle the larger question hanging over the industry: Is the growth of Chinese biotech a threat to the U.S. industry, or can the two ecosystems complement each other? David argues that drug development is fundamentally global—and that combining American strengths in breakthrough science, capital and global clinical development with Chinese strengths in drug discovery, speed and early clinical development could ultimately produce better medicines faster and at lower cost.The episode offers a practical look at how the U.S.–China biotech relationship is evolving from simple licensing transactions toward a much deeper and more interconnected model of collaboration.Connect with David:https://www.linkedin.com/in/songsong-david-cao/https://www.t2dbioadvisory.com/
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 regulatory milestones that underscore the industry's commitment to addressing complex health challenges with innovative therapeutics and strategic investments. Eli Lilly has achieved a major breakthrough with the FDA approval of Mounjaro (tirzepatide), a dual GLP-1/GIP agonist designed to reduce cardiovascular risks in individuals with type 2 diabetes. This marks a pivotal step forward in diabetes management, as it not only improves glycemic control but also offers cardiovascular protection. The approval of tirzepatide highlights the therapeutic potential of dual agonists in metabolic disorders, setting a new standard for diabetes care. This development places Eli Lilly at the forefront of incretin-based therapies, a crucial advancement given the high cardiovascular risk associated with diabetes. Priovant Therapeutics has secured its first FDA approval for Lisraya (brepocitinib), a novel TYK2/JAK1 inhibitor tablet aimed at treating dermatomyositis, an autoimmune condition characterized by muscle inflammation and skin rash. As a first-in-class therapeutic option, brepocitinib underscores the growing focus on targeted therapies that modulate specific pathways involved in autoimmune diseases. Priovant's success, following its acquisition from Pfizer, signals its emergence as a significant player in rare disease treatment. Bristol Myers Squibb is making waves with a $173 million investment to construct a second radiopharmaceutical manufacturing facility in Indiana. This strategic move aligns with the increasing demand for precision oncology treatments that utilize radiolabeled compounds for targeted cancer therapy. BMS's investment demonstrates a strong commitment to advancing personalized medicine and meeting future demands in this rapidly evolving field. Gilead Sciences has received FDA approval for Bixlenvo (bictegravir/lenacapavir), an integrase/capsid inhibitor combination pill for virologically suppressed HIV patients. This small molecule therapy offers a potent antiviral strategy by combining two mechanisms of action—integrase inhibition and capsid disruption—enhancing long-term viral suppression for HIV patients. This represents an evolution in HIV treatment, promising improved adherence and patient outcomes. In China, Hutchmed's Atled (fanregratinib) has been approved by the NMPA for treating FGFR2-fusion intrahepatic cholangiocarcinoma after successful Phase 2 trials. Fanregratinib exemplifies precision medicine's approach by targeting specific genetic alterations driving cancer progression, offering new hope for patients with this challenging condition. Cytokinetics has reported promising Phase 3 results for Myqorzo (aficamten) in non-obstructive hypertrophic cardiomyopathy. Aficamten acts as a cardiac myosin inhibitor, representing a novel therapeutic avenue that directly targets the underlying pathophysiology of this rare heart disorder. The positive outcomes from these trials support its bid for FDA approval and could expand treatment options significantly. In respiratory disease research, Generate Bio's GB-0895 has shown encouraging Phase 1 biomarker reductions in chronic obstructive pulmonary disease (COPD). This monoclonal antibody approach targets TSLP and marks progress in developing new therapies for respiratory diseases with high unmet needs. Teva Pharmaceuticals has positioned itself as the stalking horse bidder for BioXcel Therapeutics' neuroscience portfolio amid bankruptcy proceedings. Teva's bid highlights ongoing consolidation trends within the pharmaceutical industry as companies seek to bolster their portfolios through strategic acquisitions. Roche's Genentech announced a substantial deal with DualityBio worth over $1 billion for antibody-drug conjugates (ADCs), focusing on developing treatments for cancers resistant to existing ADC therapies. This partnership showcases Roche's commitment to addressing complex oncology challenges through innovative modalities. Furthermore, AusperBio has secured $120 million in series C funding to advance its oligonucleotide therapy for chronic hepatitis B through Phase 3 trials. Such funding milestones demonstrate robust investor confidence and highlight promising advancements in oligonucleotide therapeutics for chronic infections like hepatitis B. These scientific advancements highlight the dynamic landscape of the biotech and pharmaceutical industries, characterized by innovation-driven solutions across various therapeutic areas. The emphasis on targeted therapies, precision medicine, and strategic investments underscores the sector's dedication to enhancing patient care through cutting-edge science and technology. As these developments unfold, they hold significant potential to impact treatment paradigms, offering hope for improved outcomes across various diseases with high unmet needs. The industry's focus on cutting-edge research and strategic collaborations continues to drive innovations that could redefine therapeutic landscapes globally. Thank you for tuning into Pharma Daily—your source for reliable updates on the evolving world of pharmaceuticals and biotechnology. Join us next time as we continue to explore groundbreaking advancements shaping patient care worldwide.Support the show
“There isn't enough capacity for antibody-oligo conjugates out there today, full stop,” says Geoff Glass, CEO of Abzena. “And it's really because of the volume requirements for the diseases.”Geoff Glass is Chief Executive Officer of Abzena, the end-to-end, fully integrated CDMO and CRO for complex biologics and bioconjugates. He brings 30 years in life sciences, including at Patheon, Avadel, and Ncardia, and he chaired Abzena's board before taking the CEO seat last year. He's joined by Campbell Bunce, Abzena's Chief Scientific Officer, who runs discovery through GMP manufacturing across the company's San Diego, CA, Bristol, PA, and Cambridge, UK sites.Antibody-oligonucleotide conjugates (AOCs) have moved from concept to late-stage development in just a few years, attracting major investment along the way. In the latest PharmaSource podcast, Geoff and Campbell walk through where the modality came from, manufacturing considerations compared to ADCs, and the broader geopolitical and capacity challenges in the US.Read the full article.
This episode is sponsored by Gilead Sciences. Gilead had no involvement or input in the podcast content. Gilead is working to transform how cancer is treated. We are innovating with next-generation therapies, combinations, and technologies to deliver improved outcomes for people with cancer. From antibody drug conjugates and small molecules to cell therapy-based approaches, our portfolio and pipeline assets are creating new possibilities for people with cancer.Dr. Sara Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute, returns to Patient From Hell to explain the ASCENT-04/KEYNOTE-D19 study, the phase 3 trial she led as principal investigator, and what it changes for people living with metastatic triple-negative breast cancer.For years, the most effective drugs for metastatic TNBC were only available after first-line chemotherapy had already failed. The problem, as Dr. Tolaney puts it plainly, is that many patients never reach a second line of treatment at all. ASCENT-04 asked whether moving an antibody-drug conjugate to the front, paired with immunotherapy, would change that. Median progression-free survival improved from 7.8 months to 11.2 months, and treatment responses lasted significantly longer.UPDATE: Since this recorded conversation, the FDA has acted on the data discussed in this episode. On May 22, 2026, Datopotamab Deruxtecan was approved for first-line metastatic TNBC in patients who are not candidates for immunotherapy. On June 24, 2026, Sacituzumab Govitecan was approved for first-line use both as a single agent and in combination with pembrolizumab for PD-L1-positive disease (CPS ≥10). Consult with your care team for the most recent indications and availability of these treatment options.00:00 The trial that moves the best drugs first 00:31 Welcome back, Dr. Sara Tolaney 00:40 What ASCENT-04 set out to solve 02:00 Why many patients never reach second-line treatment 02:50 What PD-L1 status means for your treatment 04:12 The result: 7.8 to 11.2 months 05:29 What is an antibody-drug conjugate (ADC)? 06:33 Why TROP-2 is the target in triple-negative breast cancer 07:24 How immunotherapy works: taking the brakes off the T cell 09:01 Who was eligible for the trial 10:05 What "controlling" cancer actually means 11:44 Progression-free survival vs. duration of response 13:37 Dr. Tolaney reconsiders: what ASCENT-03 showed 15:51 How trial data reaches your oncologist's office 18:21 The testing checklist after a metastatic diagnosis 19:59 First-line treatment options today 22:27 The new paradigm: ADCs as the first-line backbone 23:51 What comes second line 25:29 Why tumor sequencing matters: somatic BRCA, TMB, trials 27:24 Twenty years of change in triple-negative breast cancer 29:28 Advice for a newly diagnosed patientSara M. Tolaney, MD, MPH is Chief of the Division of Breast Oncology and Associate Director of the Susan F. Smith Center for Women's Cancers at Dana-Farber Cancer Institute, and Associate Professor of Medicine at Harvard Medical School. She trained at Princeton University, UC San Francisco, Johns Hopkins University, and Dana-Farber Cancer Institute, and holds a Masters in Public Health (MPH) from Harvard University. She serves on the National Cancer Institute (NCI) Breast Cancer Steering Committee and is Vice Chair for Late-Stage Development in Breast Cancer for the Alliance for Clinical Trials in Oncology. She was principal investigator of ASCENT-04.
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 updates that underscore the dynamism and complexity of these industries, marked by breakthroughs, strategic shifts, and regulatory hurdles. A notable scientific advancement comes from Biokin Pharma, where their bispecific antibody-drug conjugate, Iza-Bren, has achieved its primary endpoint in a Phase 3 trial focused on lung cancer. This success underscores the promise of ADCs in oncology, particularly their ability to target cancer cells while minimizing damage to healthy tissues. This approach not only enhances the efficacy of cancer therapies but also reduces side effects, providing a compelling argument for Bristol Myers Squibb's global testing initiatives in this domain. Such advancements are pivotal as they represent a significant leap toward more personalized cancer treatments. In regulatory and corporate news, Sanofi's recent restructuring following its acquisition of Blueprint Medicines has been significant. The integration process involves laying off 229 employees and closing operations in Cambridge. This move highlights a broader trend of consolidation within the biotech sector as companies seek to streamline operations and optimize resources amid an increasingly competitive market. Meanwhile, CSL Behring, an Australian company specializing in plasma and vaccines, anticipates mid-single-digit growth by fiscal year 2027. This optimistic outlook follows a period of challenges, including impairments and leadership changes. The company attributes its recovery largely to advancements in immunoglobulin therapies, which play a critical role in treating immune deficiencies and autoimmune diseases, highlighting the importance of innovation in sustaining growth. On the clinical trial front, Amylyx Pharmaceuticals is making waves with its GLP-1 receptor antagonist Avexitide. The drug has shown promising Phase 3 results by significantly reducing hypoglycemic episodes in patients with a rare endocrine disorder. This finding could revolutionize treatment protocols for endocrine disorders beyond traditional diabetes management, emphasizing the potential of GLP-1 inhibitors to enhance patient outcomes across various conditions. The latest updates from Amylyx Pharmaceuticals further showcase these industry dynamics as they prepare for an FDA filing for Avexitide following successful trial outcomes. The drug addresses post-bariatric hypoglycemia—a critical gap in metabolic disorder management—highlighting its potential impact on patient care and market dynamics with an anticipated $1.7 billion peak sales forecast. However, not all developments have been positive. EyePoint Pharmaceuticals faced setbacks with Duravyu, their AMD drug-device combo, which did not meet expectations in a Phase 3 trial. This highlights the inherent risks of developing drug-device combinations in late-stage trials and underscores the competitive pressures from market leaders like Eylea. In another strategic shift within big pharma, Merck KGaA has laid off 20 staff members from its U.S. research team as part of an ongoing reassessment of research priorities and resource allocations. Similarly, BioMarin Pharmaceutical's $275 million acquisition of Alesta Therapeutics marks an effort to bolster their bone disease portfolio and challenge competitors like AstraZeneca in specialized therapeutic areas. BioMarin's acquisition emphasizes competition within rare diseases—a sector ripe with opportunities for innovative treatments addressing unmet needs. Technological advancements are also reshaping the landscape. Johnson & Johnson MedTech's recent software updates for its Monarch bronchoscopy robot illustrate how digital solutions are enhancing diagnostic capabilities in lung cancer detection. This aligns with industry trends towards leveraging AI and robotics to improve precision medicine. Eurofins CDMO Alphora's expansion to meet the growing demand for high-potency active pharmaceutical ingredients reflects a rising interest in targeted therapies requiring precise dosing and specialized manufacturing processes. Such trends indicate a shift toward more personalized medicine approaches that prioritize efficacy and safety. Despite setbacks faced by companies like Regeneron due to safety concerns halting clinical trials, strategic moves such as GSK's licensing agreement with Chugai Pharmaceutical for an anti-dengue antibody exemplify ongoing efforts to combat infectious diseases through innovative biologics. The collaboration between Evaxion and Duke University on AI-designed glioblastoma vaccines further illustrates how artificial intelligence is becoming integral to next-generation cancer therapies—potentially paving the way for personalized vaccines that optimize antigen selection based on individual tumor profiles. Rigel Pharmaceuticals' launch of Veppanu marks another milestone—the first FDA-approved PROTAC for advanced breast cancer—demonstrating novel mechanisms targeting pathogenic proteins effectively while offering new treatment avenues for molecularly defined cancers. These stories capture the essence of today's pharmaceutical landscape: one where innovation coexists with challenges but holds immense potential to transform healthcare delivery globally. As companies continue pushing boundaries with emerging technologies like AI integration or expanding into niche markets through strategic acquisitions—the future looks promising for delivering more targeted solutions tailored toward specific patient populations worldwide.Support the show
How have antibody trends changed over the decades? Janice Reichert, Ph.D., founder and editor-in-chief of mAbs, joins host Paul Carter, Ph.D., to discuss the evolution of monoclonal antibody therapeutics and their experiences with shaping—and documenting—the field. Their conversation covers the advances that have transformed the industry, evolving success rates for antibody therapeutics, and the growing sophistication of multispecific antibodies, antibody-drug conjugates, and more. Plus, they discuss both AI and China's emergence as major forces in antibody development. Links from this episode: Genentech mAbs
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 latest scientific advancements, regulatory milestones, and strategic business maneuvers shaping the industry. One of the standout developments comes from Otsuka with their drug Voyxact, which has shown promising results in stabilizing kidney function decline in patients with immunoglobulin A nephropathy (IgAN). In a Phase 3 trial, patients exhibited kidney function comparable to that of healthy adults. IgAN is a challenging autoimmune condition often leading to end-stage renal disease. This advancement, leveraging a monoclonal antibody to target specific pathways, could mark a new era in managing this chronic kidney disease. In oncology, Jiangsu Alphamab Biopharmaceuticals has been making waves through strategic collaborations, securing deals worth $125 million upfront and potential milestone payments reaching over $2 billion. Their focus on developing antibody-drug conjugates (ADCs) using AI and machine learning underscores the promise of precision oncology. ADCs marry the targeting precision of antibodies with potent anti-cancer drugs, highlighting robust investment and confidence in these cutting-edge therapies. Merck & Co. continues to expand its financial outlook, driven by the success of its flagship drugs like Keytruda. This monoclonal antibody remains pivotal in cancer immunotherapy, while drugs like Winrevair and Lipfendra are broadening Merck's reach into cardiovascular health. This growth trajectory reflects a strategic push toward diversifying product lines and leveraging breakthrough therapies to maintain strong financial performance. Additionally, Merck's $10.8 billion acquisition of Prometheus Biosciences aims to expand their therapeutic portfolio with targeted biologics. Although mid-stage trials showed mixed results for their anti-TL1A antibody therapy, such acquisitions are pivotal in addressing unmet medical needs. On the regulatory side, Sanofi's MenQuadfi vaccine has achieved EU approval for use in infants as young as six weeks. This approval enhances preventive measures against invasive meningococcal disease in vulnerable populations, representing a significant public health advancement. In research methodologies, Sethera Therapeutics' collaboration with Receptor.AI is notable. By integrating AI-driven platforms for polymacrocyclic peptide discovery aimed at hard-to-drug targets, they're paving the way for overcoming traditional drug discovery challenges through computational tools. However, not all news is about progress. Jazz Pharmaceuticals faced a setback by withdrawing its label indication for Zepzelca after failing Phase 3 trials for small-cell lung cancer. This underscores the inherent risks in clinical development pathways. From a financial standpoint, BioNTech has adjusted its 2025 sales forecast downward due to waning global demand for COVID-19 vaccines—a reflection of the volatile vaccine markets post-pandemic peaks. Meanwhile, Pfizer's discontinuation of its Phase 2 GIPR antagonist for obesity illustrates strategic pivots within R&D pipelines as companies reassess priorities based on trial outcomes and market potential. Recent corporate strategies include Pfizer's ambitious cost-saving plan totaling $9.7 billion through 2029. Amid economic pressures and patent expirations looming on key products like Eliquis, Pfizer is optimizing operations to stay competitive. Speculation around a possible merger between Bristol Myers Squibb (BMS) and AstraZeneca has stirred interest. With both facing patent cliffs, this merger could rejuvenate portfolios—though the strategic benefits for AstraZeneca are still debated. On the technological front, advancements in cellular therapies promise to revolutionize medicine production at the cellular level, potentially enhancing patient outcomes through more personalized treatments. The regulatory landscape is also evolving. There's a growing call for streamlining Investigational New Drug applications under the FDA's Trialblazer initiative—crucial for accelerating clinical trials and bringing innovative therapies to market swiftly. Finally, initiatives such as Boston Scientific's restructuring efforts highlight challenges within the medical device sector as companies adapt to shifting market dynamics. Overall, these developments underscore an industry in motion where innovation and adaptation are key to navigating complex landscapes and advancing patient care globally. As we look ahead, these trends will likely continue shaping the future of pharmaceuticals and biotech in profound ways.Support the show
Highlights from the PER® CME activity "From Trials to the Clinic ‒ Incorporating New Advances in Metastatic TNBC" — 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, experts William Gradishar, MD, FASCO, FACP; and Kamel Abou Hussein, MD; discuss optimizing first-line treatment selection in metastatic triple-negative breast cancer (TNBC) with emerging antibody-drug conjugates (ADCs) and biomarker-guided strategies.Earn CME credit by completing the full accredited activity (available through July 31, 2027): https://www.gotoper.com/courses/from-trials-to-the-clinic-incorporating-new-advances-in-metastatic-tnbcThis 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 an educational grant from 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.
Featuring an interview with Dr Ramez Eskander, including the following topics: Overview of antibody-drug conjugates (ADCs) and their role in the management of gynecologic cancers; considerations in sequencing (0:00) Choosing between FRɑ- and HER2-directed ADCs for dually eligible patients; role of antigenic target in predicting efficacy benefit of ADCs (7:53) Comparative efficacy and safety of ADCs and conventional chemotherapy (12:58) Current and investigational targets of ADCs in gynecologic cancers (17:14) Current research surrounding raludotatug deruxtecan (R-DXd) and its potential role in clinical practice (21:56) Safety and tolerability profiles of ADCs, including R-DXd, and potential mitigation strategies (27:36) Overview of available TROP2-directed ADCs for gynecologic cancers, including key clinical data (33:34) Evolving use of TROP2-directed ADCs for gynecologic cancers in clinical trials (39:05) Oral mucositis/stomatitis associated with TROP2-directed ADCs and potential mitigation strategies (44:38) CME information and select publications
Hey friends! Today's episode comes to you from a parking lot in the rain, with a mint hot cocoa in hand and your host absolutely dragging his butt (D-R-A-G-G-I-N-G, not D-R-A-G-O-N – I've never seen a dragon's butt and can't speak to how mine compares). I've had a bunch of internals back to back lately and I'm basically a drooling dog who found a frisbee and refuses to put it down. Sleep be darned. So instead of walking through one test start to finish, I want to share a few things that have helped me claw out a foothold in environments that are otherwise really locked down: The "good problem" of a mature client – several of these engagements are third- or fourth-year tests, and the clients actually clear findings off the board. Which is great for them and rough for me, because this year's test shouldn't look anything like last year's. All my favorite go-tos came up empty – machine account quota set to zero, no broadcast traffic tomfoolery (Responder and mitm6 got me nothing), SMB signing on everywhere, ADCS either absent or buttoned up, and a low-priv account that BloodHound says has zero interesting permissions and zero local admin anywhere. Cool cool cool. When the network's clean, go file-hunting – which means firing up Snaffler and letting it comb the shares. Normally that wraps up in about an hour. On these engagements it was running three and four hours. Then Windows told me I was out of disk – I like having Snaffler pull down copies of interesting files so I can review them locally instead of authenticating to each share. Turns out it had grabbed 50-60 gigs and left me with about eight gigs of breathing room. Tip #1: put a 1 TB drive in your drop boxes – I ran with tiny drives for years early in the 7MS days and it was always a pinch. Beyond situations like this one, sometimes you find a giant backup file or VMDK on a share and you need somewhere to put it so you can crack it open and go shopping. Tip #2: you can grow a VM disk on the fly – in Proxmox you can resize the disk on a running VM, then hop into Disk Management inside Windows and extend the C drive. Instant elbow room, no downtime. Death by a million tiny files – the real culprit was one file extension I should have excluded, and the client had hundreds of thousands of them. Rather than restart a run I was already hours into, I had AI whip up a little PowerShell loop that swept the Snaffler dump folder every 10 minutes and deleted the extensions I didn't care about. Woke up the next morning to a finished run and plenty of free space. Making a gig-sized log file readable – I fed the log into Chimas, a slick web interface for Snaffler output that lets you filter down to just the red stuff or just the likely-credential files, and sort by modified date. Watch those timestamps – I kept finding AD creds in documents, then comparing the doc's date against the account's last password reset in BloodHound and discovering the file was a year stale. Son of a biscuit. The tool that actually cracked it open: Copernic Desktop Search – my pal Jeff McJunkin recommended this to me years ago, I talked about it on the show once, and then inexplicably forgot about it. Not a sponsor, no kickbacks, just a paid tool that's earned its keep. It's basically Google for your hard drive. How I use it – install it on the Windows VM, clear out the default indexing scope entirely, and point it only at the Snaffler dump folder. The top tier (about a hundred bucks a year) will chew through PSTs, DWGs, Office docs, PDFs and more, and it OCRs images too. Indexing took the better part of a day on these engagements, but then search is instant, and it previews basically every file type without Office installed. Years ago this same tool surfaced a photo on a file share of a piece of printer paper where a sysadmin had handwritten a 40-character admin password in Bic pen. OCR for the win. What I search for – the obvious stuff like "password," plus the domain name, "plain text," and things like "=sa" to sniff out SQL admin creds. Nuggets and threads to pull – sometimes a hit is the gold. Other times it just tells you where to go dumpster-diving like a raccoon on the live share. That's how I found upgrade project plans with multiple teams and contractors involved, half-cleaned-up temp work, and high-privilege system, database and local admin creds just sitting there. Worth the hours – these didn't all end in domain admin, but they were rich, real findings, and a great teaching opportunity about what's sitting wide open to Domain Users. (Bonus: Copernic can also point straight at a UNC path with your AD creds and index it live.) Know a free alternative? – one of my favorite parts of doing this podcast is when someone writes in with "hey, there's an open source thing that does that." If that's you, I'd love to hear it! Also, on this week's TuesdayTOOLSday I walked through getting a self-hosted Bitwarden password vault (and file sender) up and running on Linux, and there's now a cheat sheet over at 7MinSec.wiki that'll get you there in about seven minutes – all the commands from the official install guide in one place, with a couple of gotchas flagged. Last thing: subscriptions to 7MinSec.club are free, but paid subs help cover hosting and the time this takes each week, and they're getting some exclusive content soon. No guilt trip here, Mom – I'm going to keep barfing up everything I learn either way. But if you've got the means, I'd sure appreciate it.
Jon Treffert was diagnosed with locally advanced muscle-invasive bladder cancer in September 2023. After 2 years of treatment, including surgical resection and 6 months with an antibody-drug conjugate (ADC), he had no evidence of disease and an intact bladder. In this episode, CANCER BUZZ speaks with Treffert about his experience receiving ADCs and how he is using his platform as a patient advocate to support other patients make informed decisions about their bladder cancer care. Guest: Jon Treffert Bladder Cancer Patient Advocate Powell, TN "I'm trying to build a community, a cohort of people like myself, who have chosen to keep their bladder, have had a complete response to EVP, and try to share lived experience." —Jon Treffert "One piece of advice I always give is tell your care team anytime you have something that's out of the ordinary." —Jon Treffert Resources: Jon's Story: "I encourage folks to do their own research." Journey to Health blog ACCC Bladder Cancer Resources ACCC Antibody-Drug Conjugate Resources
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 wealth of significant advancements and strategic moves shaping the industry landscape. AstraZeneca is making waves with its steadfast commitment to reaching an $80 billion revenue target by 2030. This ambitious goal is underpinned by strong sales in oncology and rare disease treatments, despite some setbacks with underperforming drugs like Ultomiris. The company's confidence is further reflected in its robust internal pipeline of antibody-drug conjugates (ADCs), even after discontinuing two candidates that fell short in clinical trials. This move highlights an industry-wide focus on high-potential therapeutic areas, underscoring the critical role of sustained innovation in preserving market leadership. In leadership news, Sarepta Therapeutics has appointed Michael Severino as CEO, succeeding Doug Ingram. Severino's extensive experience from AbbVie and Tessera signals a strategic shift for Sarepta, especially as it hones its focus on therapies for Duchenne Muscular Dystrophy. Leadership transitions like this can significantly impact a company's strategic direction, potentially steering it toward new therapeutic breakthroughs. On the regulatory front, Otsuka's Simtriyo has received FDA approval, marking it as a first-in-class norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) for ADHD. This approval is a major leap forward in central nervous system therapeutics, offering a non-stimulant option that could become a blockbuster drug in this underserved market. Such advancements highlight the persistent need for innovative treatments in CNS disorders. Similarly, Outlook Therapeutics has achieved FDA approval for Lytenava, a reformulated version of Roche's Avastin for wet age-related macular degeneration (AMD). This victory, following three prior rejections, exemplifies the challenges and opportunities inherent in drug reformulation and regulatory perseverance. Corporate acquisitions continue to shape industry dynamics. Argenx's acquisition of Forte Biosciences for $2.2 billion exemplifies strategic investments aimed at expanding therapeutic portfolios. Forte's promising Phase 2-stage vitiligo drug acquisition underscores the industry's shift towards biologics in managing complex autoimmune disorders. Amgen's recent layoff of approximately 40 employees aligns with broader trends of operational optimization amidst organizational restructuring. Such workforce adjustments often reflect shifts in business strategy or responses to evolving market conditions. In clinical development news, InnoCare Pharma has announced successful Phase 3 results for its oral TYK2 inhibitor Fadeucravacitinib in treating moderate-to-severe plaque psoriasis. This achievement underscores the potential of targeted therapies in addressing autoimmune conditions by modulating specific signaling pathways. The FDA's approval of Freenome's SimpleScreen CRC blood test marks a significant advancement in non-invasive diagnostic tools for colorectal cancer screening. Such innovations could dramatically impact early cancer detection and improve patient outcomes. Meanwhile, emerging insights into CAR-T therapy have identified genetic markers linked to toxicity risks in Yescarta patients. These findings can guide future CAR-T product development towards enhanced safety profiles, offering pathways for engineering safer therapies by identifying patients at higher risk for adverse effects. Finally, the partnership between Salesforce and Veterans Affairs aims to integrate AI into healthcare workflows, illustrating the increasing role of digital transformation in enhancing healthcare delivery and operational efficiency. These developments highlight the ongoing evolution towards more personalized and efficient healthcare solutions within the pharmaceutical and biotech sectors. As companies navigate complex regulatory landscapes, pursue innovative therapies, and adapt to dynamic market demands, their efforts are poised to advance patient care standards and drive future growth within these critical industries. The implications for patient care are profound, as new treatments offer hope for conditions that have long eluded effective intervention. Stay tuned with Pharma Daily as we continue to bring you the latest updates from this rapidly evolving field.Support the show
Listen in to learn from Thomas Bachelot, MD, PhD, and Mafalda Oliveira, MD, PhD, about recent advances and the integration of anti-TROP2 antibody-drug conjugates (ADCs) into the management of patients with triple-negative breast cancer, including as first-line therapy for those who are not eligible for immunotherapy. Experts will cover: The evolving role of TROP2-directed antibody-drug conjugates (ADCs), including sacituzumab govitecan and datopotamab deruxtecan, in addressing unmet needs in the frontline treatment of TNBC. Treatment sequencing, reimbursement barriers to recent approvals, and toxicity-informed treatment selection considerations. How to monitor and manage ocular and pulmonary toxicities and care-team readiness for implementing ADC-based therapy in routine practice. Presenters:Thomas Bachelot, MD, PhD Medical Oncology Department of Oncology Léon Bérard Center Lyon, France Mafalda Oliveira, MD, PhD Senior Consultant Medical Oncology Department Vall d'Hebron University Hospital Senior Clinical Investigator Breast Cancer Group Vall d'Hebron Institute of Oncology (VHIO) Vall d'Hebron Barcelona Hospital Campus Barcelona, Spain Get access to all of our new podcasts by subscribing to the Decera Clinical Education Oncology Podcast on Apple Podcasts, YouTube Music, or Spotify. Visit the program page for more content associated with this discussion. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
AUA2026: Focus on: Muscle Invasive Bladder Cancer CME Available: https://cme.auanet.org/URL/FOCUS266ONL LEARNING OBJECTIVES: After participating in this CME activity, participants will be able to: 1. Evaluate limitations in the current MIBC treatment landscape including patient outcomes and gaps in available systemic therapies to identify individuals with limited or no effective treatment options and enhance clinical decision-making. 2. Interpret the mechanisms of action and clinical data supporting antibody-drug conjugates (ADCs) to determine their potential role in addressing unmet therapeutic needs in patients with MIBC who are ineligible for traditional treatment pathways. 3. Incorporate evidence-based perioperative systemic treatment strategies including neoadjuvant and adjuvant approaches into patient care algorithms to improve pathologic response rates and survival outcomes in MIBC. 4. Apply best practices for managing and mitigating adverse events associated with emerging systemic and perioperative therapies to optimize treatment adherence and patient safety in the MIBC setting. 5. Implement strategies for effective communication, multidisciplinary care coordination, and shared decision-making between urologists, medical oncologists, and patients to improve treatment alignment and patient-centered outcomes in MIBC. ACKNOWLEDGEMENTS: Support provided by an independent educational grant from: Pfizer, Inc.
Highlights from the PER® CME activity "ADCs and Bispecific Antibodies Across Solid Tumors: Integrating New Targets, New Data, and New Decisions" — 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, experts William J. Gradishar, MD, FASCO, FACP; Rebecca Arend, MD, MSPH; Aaron Lisberg, MD; and Ulka Vaishampayan, MD, FASCO; discuss emerging antibody-drug conjugates and bispecific agents in lung, breast, endometrial, and prostate cancers, and how these agents may shift the therapeutic landscape in these disease.Earn CME credit by completing the full accredited activity (available through June 30, 2027): https://www.gotoper.com/courses/adcs-and-bispecific-antibodies-across-solid-tumors-integrating-new-targets-new-data-and-new-decisions-xqkuThis 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 an educational grant from BioNTech.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.
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
Os ADCs (anticorpos conjugados a drogas) estão entre os temas mais quentes da oncologia, com um número crescente de publicações na literatura. A definição completa, como ele funciona e como cada um de nossos experts interpretam e utilizam os ADCs você vai conferir neste episódio. E aproveitando o clima da Copa do Mundo, no final do episódio temos o bolão das aprovações nos próximos 5 anos. Cadastre-se no MOC: mocbrasil.com Siga o MOC no Instagram: @mocbrasiloficial
CME credits: 0.75 Valid until: 16-07-2027 Claim your CME credit at https://reachmd.com/programs/cme/translating-evidence-on-trop2-directed-adcs-into-global-practice-in-metastatic-tnbc/60637/ This online educational activity examines the evolving role of TROP2-directed antibody-drug conjugates (ADCs) in the frontline management of metastatic triple-negative breast cancer (TNBC). Through expert-led reviews and case-based discussions, the activity compares pivotal clinical trial data for emerging ADCs, with a focus on patients who are not candidates for immunotherapy. Faculty discuss how efficacy, safety profiles, dosing considerations, and patient-specific factors influence treatment selection and sequencing. Practical guidance on adverse event monitoring and mitigation supports personalized and evidence-based care. The activity also explores future directions for TROP2-directed ADCs in both metastatic and early-stage TNBC settings.
CME credits: 0.75 Valid until: 16-07-2027 Claim your CME credit at https://reachmd.com/programs/cme/current-unmet-needs-in-first-line-treatment-of-metastatic-tnbc/60636/ This online educational activity examines the evolving role of TROP2-directed antibody-drug conjugates (ADCs) in the frontline management of metastatic triple-negative breast cancer (TNBC). Through expert-led reviews and case-based discussions, the activity compares pivotal clinical trial data for emerging ADCs, with a focus on patients who are not candidates for immunotherapy. Faculty discuss how efficacy, safety profiles, dosing considerations, and patient-specific factors influence treatment selection and sequencing. Practical guidance on adverse event monitoring and mitigation supports personalized and evidence-based care. The activity also explores future directions for TROP2-directed ADCs in both metastatic and early-stage TNBC settings.
CME credits: 0.75 Valid until: 16-07-2027 Claim your CME credit at https://reachmd.com/programs/cme/managing-adverse-events-associated-with-trop2-directed-adcs-in-metastatic-tnbc/60635/ This online educational activity examines the evolving role of TROP2-directed antibody-drug conjugates (ADCs) in the frontline management of metastatic triple-negative breast cancer (TNBC). Through expert-led reviews and case-based discussions, the activity compares pivotal clinical trial data for emerging ADCs, with a focus on patients who are not candidates for immunotherapy. Faculty discuss how efficacy, safety profiles, dosing considerations, and patient-specific factors influence treatment selection and sequencing. Practical guidance on adverse event monitoring and mitigation supports personalized and evidence-based care. The activity also explores future directions for TROP2-directed ADCs in both metastatic and early-stage TNBC settings.
CME credits: 0.75 Valid until: 16-07-2027 Claim your CME credit at https://reachmd.com/programs/cme/case-consult-first-line-treatment-in-metastatic-tnbc-ineligible-for-immunotherapy/60634/ This online educational activity examines the evolving role of TROP2-directed antibody-drug conjugates (ADCs) in the frontline management of metastatic triple-negative breast cancer (TNBC). Through expert-led reviews and case-based discussions, the activity compares pivotal clinical trial data for emerging ADCs, with a focus on patients who are not candidates for immunotherapy. Faculty discuss how efficacy, safety profiles, dosing considerations, and patient-specific factors influence treatment selection and sequencing. Practical guidance on adverse event monitoring and mitigation supports personalized and evidence-based care. The activity also explores future directions for TROP2-directed ADCs in both metastatic and early-stage TNBC settings.
CME credits: 0.75 Valid until: 16-07-2027 Claim your CME credit at https://reachmd.com/programs/cme/comparing-first-line-trop2-directed-adcs-in-metastatic-tnbc-latest-clinical-evidence/60633/ This online educational activity examines the evolving role of TROP2-directed antibody-drug conjugates (ADCs) in the frontline management of metastatic triple-negative breast cancer (TNBC). Through expert-led reviews and case-based discussions, the activity compares pivotal clinical trial data for emerging ADCs, with a focus on patients who are not candidates for immunotherapy. Faculty discuss how efficacy, safety profiles, dosing considerations, and patient-specific factors influence treatment selection and sequencing. Practical guidance on adverse event monitoring and mitigation supports personalized and evidence-based care. The activity also explores future directions for TROP2-directed ADCs in both metastatic and early-stage TNBC settings.
CME credits: 0.75 Valid until: 16-07-2027 Claim your CME credit at https://reachmd.com/programs/cme/current-unmet-needs-in-first-line-treatment-of-metastatic-tnbc/60632/ This online educational activity examines the evolving role of TROP2-directed antibody-drug conjugates (ADCs) in the frontline management of metastatic triple-negative breast cancer (TNBC). Through expert-led reviews and case-based discussions, the activity compares pivotal clinical trial data for emerging ADCs, with a focus on patients who are not candidates for immunotherapy. Faculty discuss how efficacy, safety profiles, dosing considerations, and patient-specific factors influence treatment selection and sequencing. Practical guidance on adverse event monitoring and mitigation supports personalized and evidence-based care. The activity also explores future directions for TROP2-directed ADCs in both metastatic and early-stage TNBC settings.
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
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
Dr. Pedro Barata and Dr. Giuseppe Curigliano discuss the rapid paradigm shift of antibody-drug conjugates into frontline advanced and curative-intent perioperative settings and the clinical challenges of optimal sequencing, target selection, and cross-resistance. LINK TO FULL TRANSCRIPT
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
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
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
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.
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
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
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
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.
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
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.
In this episode of Oncology Unplugged, host Chandler Park, MD, a medical oncologist at Norton Cancer Institute in Louisville, Kentucky, was joined by Neil M. Iyengar, MD, an associate professor and co-director of Breast Medical Oncology in the Department of Hematology and Medical Oncology at the Emory University School of Medicine, as well as the director of Survivorship Services at the Winship Cancer Institute of Emory University in Atlanta, Georgia.Their conversation focused on the rapidly evolving treatment paradigm for triple-negative breast cancer (TNBC), the integration of metabolic health strategies, the clinical emergence of antibody-drug conjugates (ADCs) in the frontline metastatic setting, and the management of treatment-related toxicities.Drs Park and Iyengar examined data from the phase 3 TROPION-Breast02 trial (NCT05374512), which evaluated first-line datopotamab deruxtecan-dlnk (Dato-DXd; Datroway) in patients with PD-L1-negative metastatic TNBC. The trial demonstrated improvements in both progression-free survival and overall survival (OS) with Dato-DXd compared with standard chemotherapy. Notably, the experts also highlighted a remarkable ORR with Dato-DXd, showing that the ADC may be a robust treatment option for symptomatic patients or those experiencing rapid progression.They also discussed individualizing treatment between Dato-DXd and sacituzumab govitecan-hziy (Trodelvy) based on biomarker status, dosing schedules, and distinct toxicity profiles. Furthermore, the experts emphasized the importance of proactive management of unique ADC-associated toxicities. For Dato-DXd, they recommended prophylactic dexamethasone mouthwash and lubricating eye drops to mitigate mucositis and corneal surface events. For sacituzumab govitecan, they noted the necessity of growth factor support for neutropenia and loperamide for diarrhea.Regarding early-stage disease, they reaffirmed the phase 3 KEYNOTE-522 trial (NCT03036488) regimen of pembrolizumab (Keytruda) plus chemotherapy as the standard of care, with adjuvant escalation using capecitabine or PARP inhibitors for patients with residual disease.Drs Park and Iyengar concluded by spotlighting metabolic health interventions for patients with breast cancer. Although GLP-1 receptor agonists show promise in breast cancer survivors, Dr Iyengar cautioned against their initiation during active neoadjuvant immunotherapy due to their potential effects on pathologic complete response rates. He advocated for lifestyle interventions, including resistance training and a plant-forward, high-protein diet, to maintain lean muscle mass and improve OS outcomes.
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.
Javier Cortés, MD, PhD / Laura Huppert, MD - Novel Uses for Trusted Tools: Investigational Approaches for TROP2-Directed ADCs in Advanced Breast Cancer
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
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.
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
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.
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
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
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