Podcasts about solid tumors

This week on The Beat, CTSNet Editor-in-Chief Joel Dunning speaks with Dr. Nina Fuller-Shavel, co-chair of the British Society for Integrative Oncology (BSIO) from 2021 to 2023 and current co-chair of the BSIO Clinical Practice and Education Committee, about integrative oncology. Chapters 00:00 Intro 01:29 Integrative Medicine 09:13 Bar Dislocation, Pectus 10:53 Effective Circulating Volume Fraction 13:14 Repair vs Replacement, Edge-to-Edge 16:14 Relaxed TAVI Age Threshold? 18:14 Supravalvar Aortic Stenosis Transaxillary 20:09 How-To, AAE Tricuspid Repair 21:49 Modified Robotic Tracheobronchoplasty 23:34 Dr. Fuller-Shavel, Integrative Oncology 56:21 Upcoming Events 58:28 Closing They discuss what integrative oncology entails, mistletoe therapy, oncothermia, and the innovative integrative oncology app called Oncio. They also explore guidelines relating to this topic, nutrition, and immune checkpoint inhibitors. Dr. Fuller-Shavel also provides recommendations for supporting patients' mindfulness during cancer treatment.   Joel also highlights recent JANS articles on bar dislocation after pectus excavatum repair, effective circulating volume fraction in Type A aortic dissection, surgical mitral valve repair vs replacement after failed mitral transcatheter edge-to-edge repair, and if the age threshold for TAVI can be relaxed to below 65 years.   In addition, Joel explores minimally invasive transaxillary repair of supravalvar aortic stenosis, how to perform an aortic annulus enlargement with tricuspid repair, and modified robotic-assisted tracheobronchoplasty in a patient with severe calcific mediastinal lymphadenopathy. Before closing, he highlights upcoming events in CT surgery.    JANS Items Mentioned  1.) Bar Dislocation After Pectus Excavatum Repair: A Systematic Review of Risk Factors, Stabilization Techniques, and Management Strategies  2.) The Effective Circulating Volume Fraction in Type A Aortic Dissection: A New Risk Factor?   3.) Surgical Mitral Valve Repair vs Replacement After Failed Mitral Transcatheter Edge-to-Edge Repair: The CUTTING-EDGE Registry  4.) Could the Age Threshold for TAVI be Relaxed to Below 65 Years? Pros and Cons  CTSNet Content Mentioned  1.) Minimally Invasive Transaxillary Repair of Supravalvar Aortic Stenosis  2.) How to Perform an Aortic Annulus Enlargement With Tricuspid Repair  3.) Modified Robotic-Assisted Tracheobronchoplasty in a Patient With Severe Calcific Mediastinal Lymphadenopathy  Other Items Mentioned  1.) British Society for Integrative Oncology   2.) National Center for Integrative Oncology    3.) Integrative Oncology Approaches to Supporting Immune Checkpoint Inhibitor Treatment of Solid Tumors  4.) Aortic Valve Replacement Series   5.) Career Center    6.) CTSNet Events Calendar  Disclaimer The information and views presented on CTSNet.org represent the views of the authors and contributors of the material and not of CTSNet. Please review our full disclaimer page here.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC information, and to apply for credit, please visit us at PeerView.com/KAQ865. CME/MOC credit will be available until May 27, 2026.From Innovation to Implementation: Unlocking the Full Potential of Antibody-Drug Conjugates in Solid Tumors In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC information, and to apply for credit, please visit us at PeerView.com/KAQ865. CME/MOC credit will be available until May 27, 2026.From Innovation to Implementation: Unlocking the Full Potential of Antibody-Drug Conjugates in Solid Tumors In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC information, and to apply for credit, please visit us at PeerView.com/KAQ865. CME/MOC credit will be available until May 27, 2026.From Innovation to Implementation: Unlocking the Full Potential of Antibody-Drug Conjugates in Solid Tumors In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC information, and to apply for credit, please visit us at PeerView.com/KAQ865. CME/MOC credit will be available until May 27, 2026.From Innovation to Implementation: Unlocking the Full Potential of Antibody-Drug Conjugates in Solid Tumors In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC information, and to apply for credit, please visit us at PeerView.com/KAQ865. CME/MOC credit will be available until May 27, 2026.From Innovation to Implementation: Unlocking the Full Potential of Antibody-Drug Conjugates in Solid Tumors In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC information, and to apply for credit, please visit us at PeerView.com/KAQ865. CME/MOC credit will be available until May 27, 2026.From Innovation to Implementation: Unlocking the Full Potential of Antibody-Drug Conjugates in Solid Tumors In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC information, and to apply for credit, please visit us at PeerView.com/KAQ865. CME/MOC credit will be available until May 27, 2026.From Innovation to Implementation: Unlocking the Full Potential of Antibody-Drug Conjugates in Solid Tumors In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC information, and to apply for credit, please visit us at PeerView.com/KAQ865. CME/MOC credit will be available until May 27, 2026.From Innovation to Implementation: Unlocking the Full Potential of Antibody-Drug Conjugates in Solid Tumors In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

In today's episode, supported by Exact Sciences, we had the pleasure of speaking with Eric Christenson, MD, about the Oncodetect test, which is available for use in molecular residual disease detection in patients with solid tumors. Dr Christenson is an assistant professor of oncology at the Johns Hopkins School of Medicine in Baltimore, Maryland. In our exclusive interview, Dr Christenson discussed the capabilities of Oncodetect, its clinical applications, key findings from the Alpha-CORRECT study, and the prognostic value of this test.

Daniel Getts, the CEO and Founder of Myeloid Therapeutics, is focused on the role of myeloid cells in the immune response to solid tumors. These cells are the first responders in the immune system and play a crucial role in bridging the innate and adaptive immune response. The Myeloid Therapeutics' mRNA technology activates myeloid cells in tumors, making the tumor microenvironment hot and attracting other immune cells to fight the cancer. Daniel explains, "The ability to harness our immune systems has revolutionized how we treat cancer. Unfortunately, we still have a long way to go, and if you think about some of the worst of the worst cancers, such as pancreatic cancer, liver cancer, and so on, immunotherapy has still not gotten us to a place where we can solve this. It's our mission at Myeloid Therapeutics to overcome these challenges. We've uncovered a lot of really interesting things about these cancers in the last 20 years, and we've been harnessing that knowledge."  "Myeloid cells are at the heart of the immune system. They're the first responders. So, if you have an infection or bump your knee, these cells are immediately called to the site to wall off and prevent any more damage. However, they also serve as the bridge to adaptive immunity, the T cells and the B cells, which are also important for integrating an immune response. In the context of COVID vaccines, we talk about antibodies and T cells, it's the myeloid cells that are essential. In the context of what we've been learning, immunotherapy, up until recently, had been very focused on T cells and how to short-circuit the whole system just by using or activating those cells to kill cancer. And what we're starting to learn is to harness the full capability of our own immune systems, you've got to go back to the start. You've got to harness the myeloid compartment so you can orchestrate all immune elements to kill cancer." #MyeloidTherapeutics #MyeloidCells #ImmuneSystem #SolidTumors #Cancer #ImmuneResponse #Oncology #TumorMicroenvironment myeloidtx.com Listen to the podcast here

Daniel Getts, the CEO and Founder of Myeloid Therapeutics is focused on the role of myeloid cells in the immune response to solid tumors. These cells are the first responders in the immune system and play a crucial role in bridging the innate and adaptive immune response. The Myeloid Therapeutics' mRNA technology activates myeloid cells in tumors, making the tumor microenvironment hot and attracting other immune cells to fight the cancer. Daniel explains, "The ability to harness our immune systems has revolutionized how we treat cancer. Unfortunately, we still have a long way to go, and if you think about some of the worst of the worst cancers, such as pancreatic cancer, liver cancer, and so on, immunotherapy has still not gotten us to a place where we can solve this. It's our mission at Myeloid Therapeutics to overcome these challenges. We've uncovered a lot of really interesting things about these cancers in the last 20 years, and we've been harnessing that knowledge."  "Myeloid cells are at the heart of the immune system. They're the first responders. So, if you have an infection or bump your knee, these cells are immediately called to the site to wall off and prevent any more damage. However, they also serve as the bridge to adaptive immunity, the T cells and the B cells, which are also important for integrating an immune response. In the context of COVID vaccines, we talk about antibodies and T cells, it's the myeloid cells that are essential. In the context of what we've been learning, immunotherapy, up until recently, had been very focused on T cells and how to short-circuit the whole system just by using or activating those cells to kill cancer. And what we're starting to learn is to harness the full capability of our own immune systems, you've got to go back to the start. You've got to harness the myeloid compartment so you can orchestrate all immune elements to kill cancer." #MyeloidTherapeutics #MyeloidCells #ImmuneSystem #SolidTumors #Cancer #ImmuneResponse #Oncology #TumorMicroenvironment myeloidtx.com Download the transcript here

Will Ho, President, CEO, and Co-Founder of IN8bio, a company developing next-generation cellular therapies using gamma delta T cells, which play a unique role in bridging the innate and adaptive immune systems. GDT cell therapies may have reduced side effects compared to other T cell therapies as they can more selectively target tumor cells while sparing healthy tissue. IN8bio is conducting clinical trials using autologous and allogeneic gamma delta T cells for leukemia and glioblastoma with the goal of eliminating the cancer.   Will explains, "As you probably are aware, our immune system is generally broken down into two halves. One is the innate or the immediate portion of the system, which is why we're called IN8bio, the gamma delta T cells, which are considered innate immune cells. On the other, the adaptive is the memory part of our immune system. The gamma delta T cells bridge between both the innate and the adaptive. They actually have features across both. In particular, one of their natural functions is actually to discriminate and to distinguish between those cells that are healthy and safe versus those that are transformed or should be eliminated. That's the very challenge of cancer cells. At the end of the day, they're our own cells, and the gamma delta T cells have a unique ability to distinguish between what should be safe and left alone versus those cells that they should kill." "With the CAR T therapies, we have genetically engineered specific targets such as CD 19 or DPMA into an alpha-beta T cell - somewhat of a release and let it go. Those cells go and seek out every cell in the body that expresses its specific target and kills it. I kind of half-heartedly joke that it's a little bit like Terminator- once you let it go, it seeks its target to try to kill it, no matter the secondary damage. In many cases, we've had numerous toxicities, some of which have resulted in patient death. The gamma delta T cells are more nuanced in its approach. We have created CAR T, specifically for the biology of gamma delta T cells." "Early preclinical work shows they can discriminate between the leukemic cells that should be eliminated and the healthy tissue. This will become increasingly important as we try to target solid tumors. Solid tumors is a market that's nine times bigger than that of leukemias and lymphomas. It's challenging because the tumors, at the end of the day, are intertwined in an organ. Most likely, we need to keep those organs, whether they're your brain like in glioblastoma that we're targeting, or lung cancer or pancreatic cancer and others, we need to be able to discriminate and pick out the healthy tissue versus the tumor tissue because we can't just completely ablate the organ."  #IN8bio #CancerZero #Immunotherapy #Immunology #CancerResearch #TCellEngagers #GDTCells #CART #CellTherapy #GeneTherapy #Pharmaceuticals #BioTech #ClinicalResearch IN8bio.com Download the transcript here  

Will Ho, President, CEO, and Co-Founder of IN8bio, a company developing next-generation cellular therapies using gamma delta T cells, which play a unique role in bridging the innate and adaptive immune systems. GDT cell therapies may have reduced side effects compared to other T cell therapies as they can more selectively target tumor cells while sparing healthy tissue. IN8bio is conducting clinical trials using autologous and allogeneic gamma delta T cells for leukemia and glioblastoma with the goal of eliminating the cancer.   Will explains, "As you probably are aware, our immune system is generally broken down into two halves. One is the innate or the immediate portion of the system, which is why we're called IN8bio, the gamma delta T cells, which are considered innate immune cells. On the other, the adaptive is the memory part of our immune system. The gamma delta T cells bridge between both the innate and the adaptive. They actually have features across both. In particular, one of their natural functions is actually to discriminate and to distinguish between those cells that are healthy and safe versus those that are transformed or should be eliminated. That's the very challenge of cancer cells. At the end of the day, they're our own cells, and the gamma delta T cells have a unique ability to distinguish between what should be safe and left alone versus those cells that they should kill." "With the CAR T therapies, we have genetically engineered specific targets such as CD 19 or DPMA into an alpha-beta T cell - somewhat of a release and let it go. Those cells go and seek out every cell in the body that expresses its specific target and kills it. I kind of half-heartedly joke that it's a little bit like Terminator- once you let it go, it seeks its target to try to kill it, no matter the secondary damage. In many cases, we've had numerous toxicities, some of which have resulted in patient death. The gamma delta T cells are more nuanced in its approach. We have created CAR T, specifically for the biology of gamma delta T cells." "Early preclinical work shows they can discriminate between the leukemic cells that should be eliminated and the healthy tissue. This will become increasingly important as we try to target solid tumors. Solid tumors is a market that's nine times bigger than that of leukemias and lymphomas. It's challenging because the tumors, at the end of the day, are intertwined in an organ. Most likely, we need to keep those organs, whether they're your brain like in glioblastoma that we're targeting, or lung cancer or pancreatic cancer and others, we need to be able to discriminate and pick out the healthy tissue versus the tumor tissue because we can't just completely ablate the organ."  #IN8bio #CancerZero #Immunotherapy #Immunology #CancerResearch #TCellEngagers #GDTCells #CART #CellTherapy #GeneTherapy #Pharmaceuticals #BioTech #ClinicalResearch IN8bio.com Listen to the podcast here  

“The most effective therapies for solid tumors are also the most toxic — and we need to fix that,” says Dr. John Connolly, chief scientific officer of the Parker Institute for Cancer Immunotherapy. In this episode of the Vanguards of Health Care podcast, Connolly tells Bloomberg Intelligence pharmaceutical analyst Sam Fazeli why managing toxicity is the key to unlocking CAR-T’s potential in solid tumors. They explore the rise of in vivo cell therapies, evolving views on the tumor microenvironment and why foundational cancer vaccines may shape the future of all immunotherapy. Connolly also shares the clinical trials he’s watching closely, the ones that could flip the script on cancer care.See omnystudio.com/listener for privacy information.

Welcome to this week's podcast by VJOncology, where we delve into the emerging trends and challenges in the field of... The post Cellular therapies in solid tumors appeared first on VJOncology.

CatalYm is preparing to initiate its broad phase 2b clinical development program for visugromab to tackle multiple solid tumor indications. Visugromab is a monoclonal antibody that neutralizes the tumor-derived growth differentiation factor-15 (GDF-15), a locally acting immunosuppressant fostering immunotherapy resistance. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by reenabling immune cell activation, proliferation and Interferon-γ signature induction. Visugromab has demonstrated a good safety profile and potent and durable anti-tumor efficacy in combination with anti-PD-1 treatment in advanced cancer patients, as highlighted in its recent Nature publication and interim clinical data. This week we have a conversation with Eugen Leo, chief medical officer at CatalYm.01:30-03:38: About CatalYm03:38-06:59: Solid tumors and also why they are hard to treat06:59-09:04: Current treatments for solid tumors09:04-10:47: What is immunotherapy resistance?10:47-12:23: What is visugromab?12:23-13:32: CatalYm's clinical development program13:32-15:12: What represents success for patients using visugromab?15:12-17:50: Other treatment options being developed17:50-19:50: CatalYm's pipeline and the futureThis week's podcast was sponsored by TCR Solutions.Interested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletter

Robert Den, Chief Medical Officer at Alpha Tau Medical, is changing cancer treatment using their Alpha DaRT technology to deliver a potent form of alpha radiation directly into solid tumors with minimal side effects. There is potential for the Alpha DaRT to be combined with immunotherapy and chemotherapy to further invoke an immune response. This one-time alpha radiation treatment has shown the ability to treat all solid tumors, only limited by the ability to deliver the Alpha DaRT directly to the tumor. Robert explains, "So alpha radiation is one of the three types of radiation that occur naturally, and it's been known as a very potent form of radiation for several decades now. The challenge with alpha radiation in the treatment of patients with localized disease and with solid tumors, meaning tumors not like leukemias or lymphomas but more like pancreas, lung, and prostate cancer, is that the alpha particles themselves aren't only able to travel a very short distance inside tissue or inside the cancer itself." "Before Alpha Tau and the Alpha DaRT technology, there was no pragmatic way to use this super potent and very safe type of radiation because you could not put enough alpha particles inside a tumor to cover the tumor with the radiation dose. What Alpha DaRT technology does is rely on the movement of what's called alpha-emitting daughter atoms." "So essentially, we take a biocompatible inert metal seed, which means that if you were to put this seed into the body, there would be no immune effect. Patients could have it inside them for the entirety of their life. Essentially, what we do is we cover this seed with a radiopharmaceutical called Radium-224. We just put Radium-224 on the outside of the seed. Then, we insert it either through a minimally invasive approach or using a different endoscopic approach inside the tumor directly. So now we have the seed covered with the radium inside the tumor, and this is basically where the magic happens."   #AlphaTauMedical #Cancer #TargetedRadiation #ClinicalResearch #RadiationOncology #Oncology #CancerTreatment #AlphaRadiation  alphatau.com Download the transcript here

Robert Den, Chief Medical Officer at Alpha Tau Medical, is changing cancer treatment using their Alpha DaRT technology to deliver a potent form of alpha radiation directly into solid tumors with minimal side effects. There is potential for the Alpha DaRT to be combined with immunotherapy and chemotherapy to further invoke an immune response. This one-time alpha radiation treatment has shown the ability to treat all solid tumors, only limited by the ability to deliver the Alpha DaRT directly to the tumor. Robert explains, "So alpha radiation is one of the three types of radiation that occur naturally, and it's been known as a very potent form of radiation for several decades now. The challenge with alpha radiation in the treatment of patients with localized disease and with solid tumors, meaning tumors not like leukemias or lymphomas but more like pancreas, lung, and prostate cancer, is that the alpha particles themselves aren't only able to travel a very short distance inside tissue or inside the cancer itself." "Before Alpha Tau and the Alpha DaRT technology, there was no pragmatic way to use this super potent and very safe type of radiation because you could not put enough alpha particles inside a tumor to cover the tumor with the radiation dose. What Alpha DaRT technology does is rely on the movement of what's called alpha-emitting daughter atoms." "So essentially, we take a biocompatible inert metal seed, which means that if you were to put this seed into the body, there would be no immune effect. Patients could have it inside them for the entirety of their life. Essentially, what we do is we cover this seed with a radiopharmaceutical called Radium-224. We just put Radium-224 on the outside of the seed. Then, we insert it either through a minimally invasive approach or using a different endoscopic approach inside the tumor directly. So now we have the seed covered with the radium inside the tumor, and this is basically where the magic happens."   #AlphaTauMedical #Cancer #TargetedRadiation #ClinicalResearch #RadiationOncology #Oncology #CancerTreatment #AlphaRadiation  alphatau.com Listen to the podcast here

Solid tumors present a big challenge for current treatments. However, a new approach might provide the answers - Tumor Activated Therapy. By targeting specific proteins common in all solid tumor micro-environments, Seekyo scientists think this can induce self-destruction of the tumor itself. Seekyo's lead therapy, SKY01, can only be activated within the tumor, making it a highly-targeted solution.This differentiated approach overcomes the limits of existing treatments, such as small molecule or antibody-drug conjugates. It could also be more cost effective than many advanced, far cell and gene therapy alternatives. Seekyo is looking for clinical entry to target four of the more challenging solid cancers - pancreas, TNBC, colorectal and lung, in an umbrella PhI/IIa. This will demonstrate safety and initial efficacy readings whilst at the same time defining the lead indication to progress to later-stage development. This week, our guest is Seekyo Therapeutics' CEO, Oury Chetboun. 00:38-01:57: About Seekyo Therapeutics01:57-03:17: The challenges of treating solid tumors03:17-06:08: What is Tumor Activated Therapy?06:08-07:46: What is SKY01?07:46-08:10: What happens to the cancer cells?08:10-09:52: Does the tumor vanish? 09:52-10:16: How is it delivered?10:16-11:30: Are other companies working on tumor-activated therapies?11:30-13:09: What treatment options are being worked on for solid tumors?13:09-13:47: Long-lasting treatment13:47-15:33: Clinical trials15:33-16:22: Timelines16:22-18:08: Does the treatment have other potential applications?18:08-19:59: Cost effectiveness19:59-21:59: Is the goal to cure people? 21:59-22:46: Treatment frequency22:46-24:00: The impact of tumor size24:00-25:23: Seekyo Therapeutics' pipeline 25:23-27:27: Fund-raising27:27-30:33: Reaction to the therapyInterested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletter

In today's episode, supported by Bristol Myers Squibb, we had the pleasure of speaking with Roxana S. Dronca, MD, about the FDA approval of subcutaneous nivolumab and hyaluronidase-nvhy (Opdivo Qvantig; subcutaneous nivolumab) for advanced or metastatic solid tumors. Dr Dronca is a professor of oncology, a consultant in the Division of Hematology/Oncology in the Department of Internal Medicine, and director of the Mayo Clinic Comprehensive Cancer Center in Jacksonville, Florida. On December 27, 2024, the FDA approved subcutaneous nivolumab across approved adult, solid tumor nivolumab indications, including as monotherapy, monotherapy maintenance after completion of nivolumab in combination with ipilimumab (Yervoy), or in combination with cabozantinib (Cabometyx) or chemotherapy. This regulatory decision was backed by findings from the phase 3 CheckMate-67T trial (NCT04810078) and includes indications for melanoma, renal cell carcinoma, non–small cell lung cancer, urothelial carcinoma, head and neck squamous cell carcinoma, colorectal cancer, esophageal carcinoma, esophageal adenocarcinoma, hepatocellular carcinoma, gastric cancer, and gastroesophageal junction cancer. In our exclusive interview, Dr Dronca discussed the significance of this FDA approval across multiple solid tumor indications, pivotal findings from the CheckMate-67T trial, and how this approval represents a paradigm shift in modern cancer care delivery.

This week's podcast from VJOncology brings you the latest updates on novel checkpoint inhibitors that target LAG-3, TIGIT, and TIM3... The post Novel immune checkpoint targets beyond PD-1 and CTLA-4 in solid tumors appeared first on VJOncology.

Sonal Gupta, MD, PhD, SVP and Head of Clinical Development at Affyimmune Therapeutics talks with host Emily Walsh Martin, PhD, to explore the challenges of cell therapy clinical trials and how to move patients quickly and thoughtfully through the steps required to receive therapy in aggressive solid tumor cancers.  But first, "we've moved straight from pumpkin spice season into ASGCT Annual Meeting registration season," as Dr. Walsh Martin says. So hop online and join ASGCT, then register and take advantage of the incredible member discounts on Annual Meeting registration. We'll see you in New Orleans, May 13-17, 2025! AnnualMeeting.ASGCT.org/register Music by: https://www.steven-obrien.net/--------------------------Bright New Morning - Steven O'Brien (Used for free under a Creative Commons Attribution 4.0 License: https://creativecommons.org/licenses/by/4.0/)Show your support for ASGCT!: https://asgct.org/membership/donateSee omnystudio.com/listener for privacy information.

In this interview, we sit down with Dr. Hemant Murthy, a professor of medicine in the division of Hematology/Oncology at Mayo Clinic, to explore the groundbreaking potential of CAR T-cell therapy and the crucial role clinical trials play in advancing cancer treatments.Dr. Murthy begins by emphasizing the importance of clinical trials in hematology, reminding us that many of today's standard treatments—like oral medications for chronic myeloid leukemia or advanced therapies for multiple myeloma and acute myeloid leukemia—are the result of past clinical trials. These studies not only push boundaries but also provide a clearer future path for treating diseases.CAR T-cell therapy is a significant part of this evolving landscape. Initially viewed as a last resort for patients with limited life expectancy, CAR T- cell therapy has now become a transformative therapy, with trials showing such strong results that it's being used earlier in treatment regimens, sometimes even before other established procedures like bone marrow transplants. The therapy, which re-engineers a patient's own immune cells to fight cancer, has been particularly effective for conditions such as lymphoma and multiple myeloma. Dr. Murthy explains how this shift in timing and application has dramatically changed patient outcomes, allowing those once facing hospice care to now look forward to longer, more hopeful lives.Dr. Murthy also highlights the meticulous approval process for CAR T- cell therapies. He discusses how several CAR T products, such as axicabtagene ciloleucel and lisocabtagene maraleucel, have been approved for diseases like diffuse large B-cell lymphoma and multiple myeloma due to their success in clinical trials. Importantly, he notes that these treatments are continually evolving, and future trials may yield even better results for more patients.For patients interested in learning about clinical trials, Dr. Murthy stresses the importance of consulting with their oncologists. Trials are essential in driving the next wave of treatments, and they provide an opportunity to explore innovative therapies. He advises patients to ask about trial phases and the logistics involved, such as the number of study visits or the need to stay near treatment centers. Resources like clinicaltrials.gov can also help patients find reputable studies.Looking to the future, Dr. Murthy shares his excitement about emerging therapies, including cellular treatments for solid tumors like melanoma and sarcomas. He talks about innovative approaches like gene editing and the use of different immune cells, such as natural killer cells, to make treatments safer, faster, and more effective. As clinical trials continue to expand, they offer hope for addressing even more cancer types and improving patient care.In closing, Dr. Murthy reflects on how far cancer treatments have come and expresses optimism about the ongoing impact of clinical trials in shaping a brighter future for patients. He encourages patients to ask questions and stay engaged with their healthcare providers to explore all potential treatment options.More:ClinicalTrials.gov: https://clinicaltrials.govMayo Clinic Cancer Center: https://www.mayoclinic.org/departments-centers/cancer-centerThis season is made possible thanks to our sponsors:Kite, a Gilead company: http://www.kitepharma.com/and Bristol Myers Squibb's CAR T support services program:https://www.celltherapy360.com/ Follow the nbmtLINK on Instagram! https://www.instagram.com/nbmtlink/Or visit our website at https://www.nbmtlink.org/

The mini-protein radiopharmaceutical AKY-1189, designed to deliver the alpha-emitting isotope Actinium-225 (225Ac) to tumors expressing the Nectin-4 transmembrane protein, has been found to achieve favorable dosing to tumors, while minimizing exposure to non-target tissues, including the kidney. Data on the biodistribution and tumor uptake of the drug were reported at the 2024 EORTC-NCI-AACR 2024 Molecular Targets and Cancer Therapeutics Symposium held in Barcelona. Researcher Machaba Mike Sathekge, PhD, Professor and Head of the Department of Nuclear Medicine at the University of Pretoria and Steve Biko Academic Hospital in South Africa. He is also CEO of Nuclear Medicine Research Infrastructure and Chairman of the South African Medical Research Council.

Dr. Jeng Her, Founder and CEO of AP Biosciences, is developing T-Cube bispecific antibodies that can target cancer cells and engage T-cells to kill them more effectively and safely than existing treatments. The company is focused on treating hard-to-treat cancers such as HER2-positive breast cancer, lung cancer, head and neck cancer, and pancreatic cancer. The T-Cube bispecific antibodies use CD137 instead of CD3 to activate T-cells, which can lead to better efficacy and safety compared to other T-cell engager antibodies. Jeng explains, "So why not just take two, let's say, monospecific antibodies and then put them together and give them to the patient in the combination therapy? Instead, we wanted to develop bispecific antibodies by fusing two antibodies together into one single molecule. So what's the advantage? Eventually, what it comes down to is the therapeutic window of bispecific antibodies. This means you want your antibodies, your bispecific, to have better efficacy, better safety, and sometimes lower cost of goods since you are only expressing or producing one single drug molecule. So, the way we look at bispecific and the real advantage is not just the additive effect. It's not even the synergistic effect, which means we would like our bispecific antibodies to do something combination therapy cannot do. And that's the value of our bispecific antibodies." "Basically, we have two technology platforms. The first one is an antibody phage display library. We call it Omni-mAb. This library is a live library, which means it has more than 100 billion antibody sequences. That's a collection of the 100 billion sequences. And whatever antigen, whatever conformation of the structure of antigens you have, you could isolate a very high-affinity antibody from the library in probably 4-6 weeks."  #APBiosciences #Antibody #Biotech #Bispecific #ImmunoOncology #Cancer #SolidTumors APBioInc.com Download the transcript here

Dr. Jeng Her, Founder and CEO of AP Biosciences, is developing T-Cube bispecific antibodies that can target cancer cells and engage T-cells to kill them more effectively and safely than existing treatments. The company is focused on treating hard-to-treat cancers such as HER2-positive breast cancer, lung cancer, head and neck cancer, and pancreatic cancer. The T-Cube bispecific antibodies use CD137 instead of CD3 to activate T-cells, which can lead to better efficacy and safety compared to other T-cell engager antibodies. Jeng explains, "So why not just take two, let's say, monospecific antibodies and then put them together and give them to the patient in the combination therapy? Instead, we wanted to develop bispecific antibodies by fusing two antibodies together into one single molecule. So what's the advantage? Eventually, what it comes down to is the therapeutic window of bispecific antibodies. This means you want your antibodies, your bispecific, to have better efficacy, better safety, and sometimes lower cost of goods since you are only expressing or producing one single drug molecule. So, the way we look at bispecific and the real advantage is not just the additive effect. It's not even the synergistic effect, which means we would like our bispecific antibodies to do something combination therapy cannot do. And that's the value of our bispecific antibodies." "Basically, we have two technology platforms. The first one is an antibody phage display library. We call it Omni-mAb. This library is a live library, which means it has more than 100 billion antibody sequences. That's a collection of the 100 billion sequences. And whatever antigen, whatever conformation of the structure of antigens you have, you could isolate a very high-affinity antibody from the library in probably 4-6 weeks."  #APBiosciences #Antibody #Biotech #Bispecific #ImmunoOncology #Cancer #SolidTumors APBioInc.com Listen to the podcast here

In this JCO Precision Oncology Article Insights episode, Mitchell Elliot summarizes the article “Talazoparib in Patients With Solid Tumors With BRCA1/2 Mutation: Results From the Targeted Agent and Profiling Utilization Registry Study” by Dr. Jordan Srkalovic et al.  published on June 12th, 2024. TRANSCRIPT Mitchell Elliott: Hello, welcome to JCO Precision Oncology Article Insights. I'm your host Mitchell Elliott, an ASCO Journals Editorial Fellow. Today I'll be providing a summary of the article titled, “Talazoparib in Patients With Solid Tumors With BRCA1/ 2 Mutation: Results From the Targeted Agent and Profiling Utilization Registry Study,” by Dr. Jordan Srkalovic et al. The Targeted Agent and Profiling Utilization Registry Study is a phase 2 basket trial evaluating the anti-tumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. Results of a cohort of patients with various solid tumors with germline or somatic BRCA1 and 2 mutations treated with talazoparib are reported. BRCA1 is involved in both non homologous end joining, and homologous recombination, while BRCA2 primarily facilitates homologous recombination. These mutations are present in a range of cancers including breast, ovarian and pancreatic cancers, making them key targets for therapies that inhibit poly (ADP-ribose) polymerase or PARP, a family of proteins critical for DNA repair. PARP inhibitors like talazoparib have shown promise in treating cancers with BRCA mutations as they prevent tumors from repairing DNA damage, thus promoting cell death. Many PARP inhibitors are standard of care in both early and advanced cancers. Talazoparib was previously FDA approved for BRCA related HER2 negative breast cancer and prostate cancer. The TAPUR study aims to investigate the effectiveness of talazoparib and other types of solid tumors with BRCA1 and 2 mutations to expand its potential therapeutic applications. Eligible patients had to meet both general and drug specific criteria for inclusion in the study. General eligibility required participants to have advanced or metastatic solid tumors measurable by the RECIST version 1.1 criteria, a performance status of 0 to 2 based on the Eastern Cooperative Oncology Group Scale, and a genomic target identified through certified laboratory testing. Patients with germline or somatic BRCA1 or 2 mutations were eligible, but the genomic test did not always differentiate between these types of mutations. Additional criteria included being age 18 years or older, using effective contraception and avoiding sperm donation at the set period. Exclusion criteria included patients with HER2 negative breast cancer, prior PARP inhibitor treatments, or certain cardiovascular conditions. The study also excluded patients with recent major surgeries, coagulopathy and serious medical conditions, but there were no criteria related to prior platinum therapies. Patients received 1 milligram of talazoparib daily until disease progression, unacceptable toxicity, or other reasons for discontinuation. The primary endpoint of the study was disease control which was defined by achieving either objective response or stable disease lasting at least 16 weeks as assessed by the RECIST criteria. Secondary endpoints included objective response, progression free survival, overall survival, duration of response, duration of stable disease, and safety. The study enrolled 28 eligible patients with 20 different solid tumors that had BRCA1/2 alterations between December 2019 and September 2021 across 19 clinical sites with most patients, about 89%, enrolled from community-based locations in the United States. The most common tumor type was non-small cell lung cancer accounting for 18% of cases. All patients were included in both the safety and efficacy analyses including three with HER2 negative breast cancer and somatic BRCA alterations. Of the 28 patients, nine had tumors with BRCA1 alterations, 16 had BRCA2 alterations and three had both BRCA1 and BRCA2 alterations. Additionally, 64% of patients had tumors with coalterations and at least one DNA damage repair gene. In the study, one patient achieved a complete response, nine patients had partial response and six patients had stable disease for at least 16 weeks. The overall disease control rate was 57% with an objective response of 36%. The study rejected the null hypothesis of a 15% disease control rate with high statistical significance with a p-value of less than 0.001. The median progression free survival was 24 weeks and median overall survival was 71 weeks. Interestingly, among the 19 patients who received prior platinum-based chemotherapy, 5, or about 26%, had a partial response and 4 had stable disease while on talazoparib. While platinum therapy exposure can be associated with BRCA reversion mutations, it is notable that these patients achieve stable disease with PARP inhibitor treatment. 46% of the 28 patients experienced grade 3 - 5 adverse events or serious adverse events that were possibly related to talazoparib. 14% of patients had possible drug related serious adverse events which included conditions such as anemia, neutropenia, leukopenia, nausea and vomiting. More severe grade 4 or 5 events included anemia, neutropenia, thrombocytopenia, leukopenia, hyponatremia, and increased level of the aspartate aminotransferase and bilirubin. In conclusion, this study demonstrates that talazoparib shows significant antitumor activity in patients with advanced solid tumors carrying both BRCA1 and BRCA2 mutations, even in cancers beyond those for which PARP inhibitors are currently FDA approved. The disease control and objective response rates indicate promising results in heavily pretreated patients who have no standard treatment options left. The findings suggest that PARP inhibitors like telazoparib could be effective in a broad range of cancers, including non-small cell lung cancer, mesothelioma and hepatocellular carcinoma where PARP inhibitors are not yet approved. This could pave the way for expanding the use of these drugs in precision oncology. While talazoparib showed efficacy, the study also reported a notable incidence of grade 3 to 5 adverse events, highlighting the need for careful management of side effects, particularly in heavily pretreated patients. The study calls for further research, particularly in randomized controlled trials to confirm the efficacy of talazoparib in other cancers beyond what is currently approved. It also suggests investigating the effect of DNA damage repair gene alterations and exploring combinations of PARP inhibitors with other targeted therapies. Additionally, further studies are needed to understand the potential differences in response between BRCA1 and BRCA2 mutations. Thank you for listening to JCO Precision Oncology Article Insights and please tune into the next topic. Don't forget to give us a rating and review and be sure to subscribe so you never miss an episode. You can find all ASCO shows at www.asco.org/podcasts. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.      

We love to hear from our listeners. Send us a message.Carsten Linnemann, Ph.D., CEO of Neogene Therapeutics and Head of Oncology Cell Therapy Clinical Development, AstraZeneca joins Cell & Gene: The Podcast's Erin Harris to discuss T-cell receptor (TCR) therapies for solid cancers. They talk through key challenges and opportunities in developing TCR therapies targeting neoantigens as well as the potential benefits of TCR-T therapies for cancer treatment. Linnemann shares his thoughts on the future landscape of cell therapy in oncology and beyond. Previous episodes of Cell & Gene: The Podcast have focused on TCR therapies, including Episode 50, featuring Affini-T Therapeutics' Co-Founder, CEO, and President Dr. Jak Knowles. Be sure to check out that episode, too. https://www.cellandgene.com/doc/targeting-oncogenic-drivers-for-solid-tumor-cancers-with-affini-t-therapeutics-dr-jak-knowles-0001

Details of the expanding range of cell therapies beyond hematologic malignancy were reported at the 2024 Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) by Oliver Dorigo, MD, PhD, Director of the Division of Gynecologic Oncology at the Stanford Women's Cancer Center in Stanford University. After his talk at CSCO, Dorigo told Oncology Times reporter Peter Goodwin about the promise cell therapies held for improving outcomes in ovarian cancer and other solid tumors, as well as the benefit of the exchange of ideas flowing between China, U.S., and other global players in this young science.

CME credits: 0.75 Valid until: 30-08-2025 Claim your CME credit at https://reachmd.com/programs/cme/pivotal-data-on-targeting-her2-in-her2-expressing-solid-tumors/26791/ This online MinuteCE program delves into the significance of HER2 as an actionable biomarker across various tumor types, emphasizing its implications for targeted therapies and clinical decision-making. Participants will evaluate emerging data on the efficacy of HER2-directed agents in advanced HER2-positive solid tumors and learn evidence-based strategies to monitor and mitigate treatment-related adverse events. Enhance your expertise so that you can optimize treatment adherence and improve patient outcomes.

CME credits: 0.75 Valid until: 30-08-2025 Claim your CME credit at https://reachmd.com/programs/cme/significance-of-her2-expression-in-solid-tumors/26788/ This online MinuteCE program delves into the significance of HER2 as an actionable biomarker across various tumor types, emphasizing its implications for targeted therapies and clinical decision-making. Participants will evaluate emerging data on the efficacy of HER2-directed agents in advanced HER2-positive solid tumors and learn evidence-based strategies to monitor and mitigate treatment-related adverse events. Enhance your expertise so that you can optimize treatment adherence and improve patient outcomes.

David Mazzo, President and CEO of Lisata Therapeutics, has a lead program focused on metastatic pancreatic ductal adenocarcinoma. The Lisata CendR Platform and drug certepetide efficiently augment the effects of chemotherapy and immunotherapies in the tumor microenvironment. Based on early findings, the future of cancer treatment may involve combining existing therapies with certepetide to personalize treatment for most solid tumors. David explains, "At Lisata, we're developing therapies to combat a challenging problem in the medical field today, which is the effective treatment of solid tumors. Solid tumors are very difficult to treat for two very simple reasons. On the one hand, these tumors generate a layer of cells around them that acts as a physical barrier. It's called the tumor stroma, and it prevents the penetration of many anti-cancer medicines into the tumor, which is why you often don't get the kind of results that one would expect." "The other obstacle these tumors present is that they generate or express a tumor microenvironment that is immunosuppressive, which helps the tumor hide from your innate immune system. It helps it not respond very well to externally administered immunotherapies. When you combine these two challenges, you end up with a set of diseases that remains an enigma in medical science today."   "So our therapy at Lisata called certepetide, our lead product, actually combines the ability to target and penetrate tumors more effectively for co-administered anti-cancer drugs with the ability to modify the tumor microenvironment, making it more immunoreceptive and therefore more likely to respond to your immune system and immunotherapies."  #Lisata #Oncology #Cancer #SolidTumors #Immunotherapies #TumorMicroEnvironment lisata.com Download the transcript here

David Mazzo, President and CEO of Lisata Therapeutics, has a lead program focused on metastatic pancreatic ductal adenocarcinoma. The Lisata CendR Platform and drug certepetide efficiently augment the effects of chemotherapy and immunotherapies in the tumor microenvironment. Based on early findings, the future of cancer treatment may involve combining existing therapies with certepetide to personalize treatment for most solid tumors. David explains, "At Lisata, we're developing therapies to combat a challenging problem in the medical field today, which is the effective treatment of solid tumors. Solid tumors are very difficult to treat for two very simple reasons. On the one hand, these tumors generate a layer of cells around them that acts as a physical barrier. It's called the tumor stroma, and it prevents the penetration of many anti-cancer medicines into the tumor, which is why you often don't get the kind of results that one would expect." "The other obstacle these tumors present is that they generate or express a tumor microenvironment that is immunosuppressive, which helps the tumor hide from your innate immune system. It helps it not respond very well to externally administered immunotherapies. When you combine these two challenges, you end up with a set of diseases that remains an enigma in medical science today."   "So our therapy at Lisata called certepetide, our lead product, actually combines the ability to target and penetrate tumors more effectively for co-administered anti-cancer drugs with the ability to modify the tumor microenvironment, making it more immunoreceptive and therefore more likely to respond to your immune system and immunotherapies."  #Lisata #Oncology #Cancer #SolidTumors #Immunotherapies #TumorMicroEnvironment lisata.com Listen to the podcast here

Listen to a soundcast of the June 13, 2024, and June 21, 2024, Augtyro (repotrectinib) for NTRK gene fusion-positive solid tumors and Krazati (adagrasib) for KRAS G12C-mutated colorectal cancer.

Host: Matt Birnholz, MD Guest: Saad Kenderian M.B, Ch.B CAR T-cell therapy has been revolutionary in the treatment of blood cancers like chronic lymphocytic leukemia and multiple myeloma, and according to recent research, this therapeutic approach may also help patients with thyroid cancer. However, there are several challenges associated with applying this technology to target solid tumors in thyroid cancer, like tumor heterogeneity and resistance. Joining Dr. Matt Birnholz to talk about these challenges and how a research team is working to overcome them is Dr. Saad J. Kenderian, Assistant Professor of Oncology, Immunology, and Medicine at the Mayo Clinic in Rochester, Minnesota.

We love to hear from our listeners. Send us a message.KSQ Therapeutics' CSO, Micah Benson, Ph.D., joins Erin Harris to discuss how Tumor-Infiltrating Lymphocytes (TILs) as a treatment modality have the potential to treat a variety of solid tumor types. Benson explains KSQ's Phase 1/2 clinical study, KSQ-001EX, which consists of TILs in which the SOCS1 gene is inactivated by CRISPR/Cas9 gene editing. In addition to solid tumors, Benson also addresses the therapeutic potential for autoimmune disease.

Dr Kummar discusses the significance of targeting TP53 Y220C in solid tumors and early data reported with rezatapopt in TP53 Y220C–mutant solid tumors.

Listen to a soundcast of the April 5, 2024, FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-positive solid tumors.

·       Nascentmc.com for medical writing assistance for your company.Visit nascentmc.com/podcast for full show notes Cilta-cel for Myeloma: The FDA approved ciltacabtagene autoleucel (Carvykti; cilta-cel) for adults with relapsed or refractory multiple myeloma who have tried at least one prior therapy including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. This CAR T-cell therapy, initially approved in 2022, was confirmed effective in the phase 3 CARTITUDE-4 study, showing significant reduction in disease progression or death risk by 59% compared to standard care. Enhertu for HER2-positive Solid Tumors: Fam-trastuzumab deruxtecan-nxki (Enhertu) received FDA approval for treating unresectable or metastatic HER2-positive solid tumors in adults who have had previous systemic treatment and lack satisfactory alternative options. This therapy, a conjugate of an anti-HER2 antibody and a cytotoxic drug, was first approved in 2019 and targets HER2-expressing cancer cells to potentially minimize damage to normal tissues. Fanapt for Bipolar: Iloperidone (Fanapt) has been approved for the acute treatment of manic or mixed episodes in adults with bipolar I disorder. Previously approved for schizophrenia, iloperidone targets neurotransmitters like dopamine and serotonin. It demonstrated efficacy in a pivotal trial, showing significant improvement on the Young Mania Rating Scale. Zevtera for Multiple Bacterial Infections: Ceftobiprole medocaril sodium (Zevtera) was approved for treating adults with Staphylococcus aureus bloodstream infections, right-sided infective endocarditis, and acute bacterial skin and skin structure infections. Also approved for pediatric community-acquired bacterial pneumonia, ceftobiprole is a broad-spectrum cephalosporin that combats various bacteria including MRSA. TriClip for Tricuspid Regurgitation: The FDA approved the TriClip™ transcatheter edge-to-edge repair system for treating tricuspid regurgitation. This minimally invasive option clips the tricuspid valve leaflets to improve blood flow and prevent the need for surgery. The TRILUMINATE Pivotal trial showed significant improvements in TR severity and quality of life with a good safety profile. Revumenib for Acute Leukemia: The FDA granted priority review to revumenib (SNDX-5613) for treating adult and pediatric patients with relapsed or refractory acute leukemia with KMT2A rearrangements. As a new therapeutic agent, revumenib inhibits the menin-MLL protein interaction crucial in leukemic transformation. Early trial results show promising remission rates, with a PDUFA action date scheduled for September 26, 2024.  

Featuring perspectives from Dr Andrew M Evens and Dr Sonali M Smith, including the following topics:  Introduction: CD3-Based Bispecific Antibodies and the General Medical Oncologist: Lymphomas, Multiple Myeloma … and Solid Tumors? (0:00) Follicular and Mantle Cell Lymphoma (7:17) Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma (30:10) CME information and select publications   

Hans Hammers discusses trial design and patient selection in the adjuvant setting.

ChatGPT4 in medical writing and editing at learnAMAstyle.com Nascentmc.com for medical writing assistance for your company. Visit nascentmc.com/podcast for full show notes Tricuspid Valve Replacement System for Tricuspid Regurgitation The FDA approved the Evoque tricuspid valve replacement system, a first in the U.S. for a transcatheter tricuspid device, after the TRISCEND II trial showed significant improvements in TR grade and patient symptoms. TR, where the heart's valve does not close properly causing blood backflow, can now be treated with this device, which also received CE Mark approval in Europe and is produced by Edwards Lifesciences. Afami-Cel for Synovial Sarcoma The FDA is prioritizing the review of afamitresgene autoleucel (afami-cel) for advanced synovial sarcoma, based on positive results from the SPEARHEAD-1 trial showing a 39% response rate and increased survival rates. Afami-cel targets MAGE-A4 in synovial sarcoma, a rare soft tissue sarcoma, offering a new treatment option for this aggressive disease. It's manufactured by Adaptimmune Therapeutics with a decision expected by August 4, 2024.  Pulsed Field Ablation for Atrial Fibrillation Boston Scientific's FARAPULSE PFA System has been FDA approved for treating intermittent atrial fibrillation, offering a non-thermal, tissue-selective ablation alternative with proven safety and efficacy. The approval was based on the ADVENT study and real-world data, highlighting shorter ablation times and no severe side effects. Boston Scientific plans an immediate U.S. launch. Shorter Turnaround Time for Axi-cel The FDA approved a manufacturing process change for axi-cel (Yescarta), reducing delivery time from 16 to 14 days, which is a CD19-directed CAR T-cell therapy for certain lymphomas. This change, granted to Kite, a Gilead Sciences subsidiary, aims to improve treatment accessibility by offering faster delivery of this personalized therapy. AI Algorithm for Cervical Cancer Screening Hologic's Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm has been FDA approved, introducing the first digital cytology platform integrating AI for cervical cancer screening. This system digitizes traditional Pap test slides, applying AI to enhance detection of pre-cancerous and cancerous cells, improving sensitivity and enabling remote case review. It will be available in the U.S. in early 2024. Trastuzumab Deruxtecan for Solid Tumors The FDA granted priority review to trastuzumab deruxtecan for treating unresectable or metastatic HER2-positive solid tumors, potentially marking it as the first HER2-directed, tumor-agnostic therapy. Based on the DESTINY-PanTumor02 study, showing promising survival outcomes, a decision is expected in the second quarter of 2024. The drug is developed by AstraZeneca and Daiichi Sankyo.  

Paul Lammers, M.D., M.Sc., CEO of Triumvira Immunologics joins Cell & Gene: The Podcast to talk to Host Erin Harris about TAC, the company's proprietary T cell Antigen Coupler, which has both autologous and allogeneic approaches. They also discuss targeting relapsed or refractory HER2-positive solid tumors and CLDN18.2-positive solid tumors. And they cover a realistic outlook on the evolution of cancer treatment.

Drs Simeone and Fakih discuss the main objective and design of the observational BASECAMP-1 study and how it functions alongside the EVEREST-1 study, which is evaluating the autologous CAR T-cell therapy A2B530 in patients with CEA-expressing solid tumors that have lost HLA-A*02 expression.

Dr Dumbrava discusses the rationale and design of the PYNNACLE trial; phase 1 efficacy and safety findings with PC14586 in patients with p53 Y220C–mutated advanced solid tumors; and the next steps for this research.

Can wastewater-based surveillance identify the start of the pediatric RSV season? Find out about this and more in today's PV Roundup podcast.

Synopsis: Michelle Werner is the CEO of Alltrna and a CEO-Partner at Flagship Pioneering. Alltrna is the world's first tRNA platform company to decipher tRNA biology and pioneer tRNA therapeutics to treat thousands of diseases. Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Michelle discusses her 20+ year career in drug development and the importance of bringing new innovations to people who need them. She talks about her motivations behind going to business school in London and why she felt she needed to supplement her science and math education with the fundamentals of business in order to transition her career to commercial from R&D. She discusses tRNA as a treatment modality and its potential to be a platform technology. Finally, she shares where the company is from a development perspective and fundraising announcements. Biography: Michelle C. Werner is a seasoned pharmaceutical executive with more than 20 years in the industry spanning both commercial and research & development (R&D) responsibilities. Most recently, Michelle served as Worldwide Franchise Head, Solid Tumors at Novartis Oncology, where she was responsible for delivering the disease area strategies across multiple tumors and led business development efforts resulting in a doubling of long-term portfolio value for the franchise. Previous to Novartis, Michelle was a senior leader at AstraZeneca, where she held multiple positions during her five-year tenure. As Global Franchise Head in Hematology, Michelle was critical in launching multiple indications worldwide for CALQUENCE® and was responsible for developing the mid- and long-term strategy for AstraZeneca in hematology. Prior to this role, Michelle served as Head of US Oncology, where she led the business through dramatic growth in both team and revenue through eight-plus product launches as well as Country President for the Nordics and Baltics, where she also served as an elected Board Member to Sweden's pharmaceutical industry association. Previous to AstraZeneca, Michelle was with Bristol Myers Squibb for 10 years in various positions of increasing responsibility including roles in sales, marketing, and market access in the US and UK, and above market in Europe (based in France) and global almost exclusively in oncology. Michelle started her professional career in R&D, working hands-on with patients at the Oncology Clinical Trials Unit at Harvard Medical School before moving into industry in clinical operations. Outside of her corporate responsibilities, Michelle is a wife and mother to three children and is a member of the rare disease community. She is currently serving a Board appointment for the non-profit organization Rare Disease Renegades, a purpose that fuels her passions both personally and professionally. Michelle holds a B.A. in biology & anthropology from the University of Pennsylvania and an MBA from the London Business School (UK). She also completed an Executive Education program for Women on Boards at Harvard Business School in 2018.

“It's really important to look at where your target is and what the toxicities are associated with hitting that target. Make sure you include that thinking when you're talking about bispecifics,” ONS member Rowena (Moe) Schwartz, PharmD, BCOP, professor of pharmacy practice at the James L. Winkle College of Pharmacy at the University of Cincinnati in Ohio, told Jaime Weimer, MSN, RN, AGCNS-BS, AOCNS®, manager of oncology nursing practice at ONS, during a discussion about the use of bispecific monoclonal antibodies in hematologic cancers and solid tumors.   You can earn free NCPD contact hours after listening to this episode and completing the evaluation linked below.   Music Credit: “Fireflies and Stardust” by Kevin MacLeod  Licensed under Creative Commons by Attribution 3.0  Earn 0.5 contact hours of nursing continuing professional development (NCPD), which may be applied to the treatment ILNA category, by listening to the full recording and completing an evaluation at myoutcomes.ons.org by September 1, 2025. The planners and faculty for this episode have no relevant financial relationships with ineligible companies to disclose. ONS is accredited as a provider of NCPD by the American Nurses Credentialing Center's Commission on Accreditation.  Learning outcome: The learner will report an increase in knowledge related to bispecific monoclonal antibodies in hematologic cancers and solid tumors.  Episode Notes  Complete this evaluation for free NCPD.  ONS Voice drug reference sheets and FDA announcements about bispecific anticancer therapies  ONS resources for cytokine release syndrome  Oncology Nursing Podcast Episode 176: Oncologic Emergencies 101: Cytokine Release Syndrome  Clinical Journal of Oncology Nursing article: STAT: Cytokine Release Syndrome  Clinical Practice Resource  Clinical Practice Video  Huddle Card™  Cancer article: The BiTE (Bispecific T-Cell Engager) Platform: Development and Future Potential of a Targeted Immuno-Oncology Therapy Across Tumor Types  Pharmaceutics article: Bispecific Antibodies in Cancer Immunotherapy: A Novel Response to an Old Question  U.S. Food and Drug Administration label search for package inserts  To discuss the information in this episode with other oncology nurses, visit the ONS Communities.   To find resources for creating an ONS Podcast Club in your chapter or nursing community, visit the ONS Podcast Library.  To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org.  Highlights From Today's Episode  “When we talk about bispecifics, we need to really pay attention to both the target on the cancer and the target for T-cell engaging, because that impacts both efficacy but also toxicity.” TS 4:20  “If you really look deep into the clinical trials, often the patients that are receiving these agents in clinical trials have had more than the required three or four lines of treatment. They may have had five or more lines of treatment. So it's really important to kind of look at where it sits right now, knowing, of course, that that's an evolving target.” TS 7:13  “One of the things I think can be missed, at times, is the fact that you need to consider the toxicities associated with your target on the cancer cell.” TS 10:06  “In terms of mitigating risk, there's been two major ways that have been done. One is a step-up dose schedule, and so one of the key things I would say: If you're not familiar with an agent that you're going to be administering, it's really important to review the entire step-up scheme because it's different for each agent. In some cases, patients need to be admitted to the hospital for the entire step-up strategy. Other times it's just the first dose. So it's really important to look at that.” TS 11:58  “I think we're going to get to the point where our teaching strategy is going to have to be somewhat tailored to the agent we're giving. So, how the drug is given during the step-up, what the subsequent cycling is going to be, whether it's going to be a Q21-day cycle or a weekly dosing administration or every-two-week administration after a certain point. So, I think some understanding of what to expect going forward because these are drugs that are given continually in most situations and so it's important for people to know what to expect.” TS 14:25  “I think we're going to see bispecifics that perhaps engage other aspects of the immune system besides CD3. In fact, those are in clinical trials. And I do believe that we're going to see these more and more developed for cancers beyond the hematologic malignancies. There's a lot of work being done at looking at targets that we know are helpful targets in certain cancers. And I think we'll see more drugs approved beyond the myeloma and the lymphoma and the leukemia space.” TS 20:42