Vividion Therapeutics, Inc.

BOSTON--(BUSINESS WIRE)-- #Biotech -- Odyssey Therapeutics, Inc. , a biotechnology company pioneering next-generation precision immunomodulators for inflammatory diseases, today announced the formation of its Scientific Advisory Board (SAB), which includes renowned experts in the fields of immunology and therapeutic development. The SAB will be chaired by Stephen Blacklow, M.D., Ph.D., who holds positions at Harvard Medical School and the Dana- Farber Cancer Institute and is a recognized drug discovery innovator. “The lens by which we evaluate therapeutic opportunities is supported by the profound knowledge of immune biology among our team and trusted advisors,” said Gary Glick, Ph.D., founder and CEO of Odyssey Therapeutics. “We are fortunate to work with a group of preeminent scientific minds and recognized drug hunters with extensive track records in developing molecules that have successfully translated from scientific hypothesis to clinical validation and regulatory success. We look forward to benefiting from their collective experience as we move our lead programs into the clinic and advance our earlier-stage pipeline.” Dr. Blacklow commented, “I am excited to work alongside Gary, my esteemed SAB members and the Odyssey team. Odyssey’s differentiated approach and dedication to advancing medicines for inflammatory disease is inspiring, and I look forward to contributing my expertise to help drive these groundbreaking programs forward.” Odyssey’s SAB is comprised of the following members: Dr. Blacklow, M.D., Ph.D., Gustavus Adolphus Pfeiffer Professor and Department Chair of Biological Chemistry and Molecular Pharmacology at Harvard Medical School, member of the Department of Cancer Biology at the Dana-Farber Cancer Institute: Dr. Blacklow is a globally recognized expert in signal transduction at the structural and molecular level. His research on the Notch pathway, a complex signaling pathway integral to immune cell function, has led to the development of multiple investigational therapies for hematologic malignancies, such as T cell acute lymphocytic leukemia. Of his many awards and affiliations, Dr. Blacklow received the National Cancer Institute’s prestigious Outstanding Investigator Award in 2017, and was elected to the Association of American Physicians in 2018 and the American Academy of Arts and Sciences in 2024. He received his M.D. and Ph.D. degrees from Harvard University. Robert Abraham, Ph.D., former Executive Vice President of Cancer Biology at Odyssey: Dr. Abraham previously served as Chief Scientific Officer at Vividion Therapeutics, which was acquired in August 2021 by Bayer for $2 billion. He has extensive experience in both the pharmaceutical industry and academia, including 10 years at Pfizer where he served as Senior Vice President and group head in Oncology Research and Development, with oversight of cancer drug discovery and early clinical development. He previously held roles at Duke University Medical Center, including an Endowed Chair in the Department of Cancer Biology. Throughout his career, he has made significant contributions to multiple research areas, including cell signaling, T lymphocyte biology, rapamycin pharmacology and mTOR functions, cancer metabolism and DNA damage responses. He received a B.S. in biology from Bucknell University and a Ph.D. in pharmacology from the University of Pittsburgh. Richard Flavell, Ph.D., F.R.S., Sterling Professor of Immunobiology, Yale School of Medicine, and Investigator, Howard Hughes Medical Institute: Dr. Flavell is a co-discoverer of introns in cellular genes, and his research focuses on the molecular and cellular mechanisms that govern immune responses, from the characterization of signal transduction pathways to the regulation of immune cell differentiation and activation. His work has been instrumental in identifying key components of the innate immune system, such as Toll-like receptors (TLRs) and Nod-like receptors (NLRs), and activation of the innate immune system and inflammatory disease. He received his B.Sc. and Ph.D. in biochemistry from the University of Hull, England. Alexander (Sasha) Rudensky, Ph.D., Director, Ludwig Center for Cancer Immunotherapy, Tri-Institutional Professor at Memorial Sloan Kettering Cancer Center, The Rockefeller University and Cornell University, and Investigator, Howard Hughes Medical Institute: Dr. Rudensky’s research has defined regulatory T cells and the roles they play in autoimmunity, tolerance, allergic disease, infections and cancer. His current work addresses the molecular mechanisms underlying regulatory T cell activity, and the role these cells play in autoimmunity, tumor immunity and immunity to infections. He received his candidate of sciences degree from the Gabrichevsky Research Institute of Epidemiology and Microbiology, Moscow, and completed his postdoctoral work at the Yale School of Medicine. Ruslan Medzhitov, Ph.D., Sterling Professor, Yale University School of Medicine and Investigator, Howard Hughes Medical Institute: Dr. Medzhitov’s work has identified innate immune sensing pathways and established the principle of innate control of adaptive immunity. His current research is focused on inflammation biology, allergic diseases and evolutionary medicine. Dr. Medzhitov has been a recipient of numerous awards and honors, including the 2019 Dickson Prize in Medicine. He earned his Ph.D. from Moscow State University. Sun Hur, Ph.D., Professor at Harvard Medical School and Boston Children’s Hospital and Investigator, Howard Hughes Medical Institute: Dr. Hur’s work on the molecular mechanisms of how the immune system distinguishes between self and non-self-entities led to the discovery of MDA5 and its role in innate immunity, autoimmunity and autoinflammatory diseases. She is a past recipient of the Vilcek Prize for Creative Promise in Biomedical Science for her research on inflammatory and autoimmune diseases and experimental enzymology. She earned her B.Sc. from Ewha Womans University and her Ph.D. in physical chemistry from the University of California, Santa Barbara. Seth Masters, Ph.D., Centre Head, Centre for Innate Immunity and Infectious Diseases, Hudson Institute of Medical Research: Dr. Masters’ research on understanding the innate immune pathways that drive diseases led to the identification of the mechanisms by which NLRP1 mediates autoinflammatory disease. His current research explores how innate immune pathways contribute to inflammatory bowel disease, asthma, metabolic diseases and neurodegeneration. Dr. Masters obtained his B.Sc. in biochemistry from The University of Melbourne, Australia, and his Ph.D. in medical biology from the Walter and Eliza Hall Institute. Michael B. Yaffe, M.D., Ph.D., Professor of Biology and Engineering, Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology: Dr. Yaffe’s research focuses on uncovering signaling pathways in cells that respond to stress, DNA damage and inflammatory cytokines and how the outputs of these pathways are integrated at the molecular and systems level to control the cell outcomes. Dr. Yaffe received his B.S. in materials science and engineering from Cornell University, M.D., Ph.D. degrees from Case Western Reserve University and advanced postdoctoral training with Prof. Lew Cantley at Harvard Medical School. About Odyssey Therapeutics Odyssey Therapeutics is a clinical-stage biotechnology company focused on discovering, developing and commercializing the next generation of inflammatory precision medicines. Since its founding in 2021, Odyssey has rapidly advanced a pipeline of clinical- and research-stage programs, leveraging the scientific expertise of its team of drug hunters and a comprehensive suite of tools to tackle drug targets with the greatest potential to benefit patients. Odyssey’s mission is to create extraordinary leaps in patient outcomes and change the standard of care for those living with serious inflammatory diseases. For more information, please visit odysseytx.com and follow Odyssey Therapeutics on X (formerly Twitter) and LinkedIn . Contacts Josh George jgeorge@spectrumscience.com 713-828-1913

BRISBANE, Calif.--( BUSINESS WIRE )--Gate Bioscience, a biotechnology company developing a new class of small molecule medicines to eliminate disease-causing proteins at their source, today announced the appointment of Jeff Hatfield to its Board of Directors. Mr. Hatfield brings more than three decades of successful industry leadership across biotech and pharmaceuticals. “We are thrilled that Jeff is joining Gate’s Board of Directors,” said Jordi Mata-Fink, Ph.D., Co-founder and Chief Executive Officer of Gate. “Jeff has built and led multiple chemistry platform companies based on novel cutting-edge approaches, leading to many first-in-class programs in critical disease areas and successful outcomes for patients and shareholders alike. We look forward to benefiting from his expertise as we develop our Molecular Gate medicines.” Mr. Hatfield’s significant platform company leadership experience includes serving as Chief Executive Officer of Vividion Therapeutics, a pioneer in the development of chemoproteomics. At Vividion, he led the development of a portfolio of first-in-class oncology and immunology programs before the company’s 2021 acquisition by Bayer Pharmaceuticals, which delivered $1.5 billion upfront and $0.5 billion in CVR earn-outs to shareholders. He also served as CEO of Vitae Pharmaceuticals, where he built an early innovator position in AI/ML computational drug discovery before that company’s 2016 acquisition by Allergan for $640 million. Mr. Hatfield currently serves as Chair of ROME Therapeutics and Vividion, as well as serving on the board of directors for VIR Biotechnology and the advisory boards of Lime Therapeutics and the Harvard Business School’s Blavatnik Fellowship in Life Science Entrepreneurship. Earlier in his career, Mr. Hatfield held senior leadership roles at Bristol Myers Squibb, including Senior Vice President, Immunology; President, BMS-Canada; and Head of U.S. Market Access. He earned an MBA from The Wharton School of the University of Pennsylvania, and a B.S. from the Purdue University College of Pharmacy. “Gate’s new therapeutic mechanism – selectively blocking the secretory translocon with small molecules to potently eliminate extracellular disease-causing proteins – is unique and powerful,” said Mr. Hatfield. “This science has the potential to quickly identify high-value, first-in-class therapeutics in the inflammatory, cancer and neurodegenerative fields. This is an exciting time to join the company, with the platform fully operational and multiple discovery programs rapidly taking shape. I look forward to working with Gate to bring new therapies to patients in need.” Mr. Hatfield joins Gate’s Board of Directors that includes Dr. Mata-Fink, Thomas Daniel, M.D., former President of Global Research and Early Development at Celgene, Clare Ozawa, Ph.D., Managing Director at Versant Ventures, and Vineeta Agarwala, M.D. Ph.D., General Partner at a16z Bio + Health. About Gate Bioscience Gate Bioscience is creating a new class of medicines called Molecular Gates, small molecules that selectively eliminate harmful extracellular proteins at their origin: inside the cell. Every extracellular protein—of which there are more than 4,000—must pass through a single channel in the cell before it can be secreted into the body. Molecular Gates recognize and block specific disease-causing proteins from exiting the channel, causing them to be degraded by the cell instead of being secreted. By eliminating the harmful protein at the source, Gate aims to eliminate the disease for patients. Founded in 2021, Gate is backed by Versant Ventures, a16z Bio + Health, ARCH Venture Partners, and GV. Learn more at www.gatebio.com .

Bayer is applying its new operating model for key drugs elinzanetant and Nubeqa. Bayer’s massive reorganization championed by CEO Bill Anderson is bringing major changes to the German company’s pharma commercial team, shaking up its structure, personnel and operations. “We are transforming from a company that has been largely focused on hierarchy within functions to an organization—and supporting design—that really focuses on customers and products,” Christine Roth, head of global commercialization at Bayer’s pharmaceutical division, said in a recent interview with Fierce Pharma. Roth’s promotion to her current position was part of the restructuring as Bayer shrank its pharma executive team. The former oncology business chief officially started to lead a newly formed commercialization organization on June 1. The purpose of the groupwide overhaul was to reduce Bayer’s levels of bureaucracy, as job reductions were expected to mainly affect managerial roles. The new operating model, dubbed “dynamic shared ownership,” or DSO, promises fewer organizational layers and more agility for employees. While layoffs across Bayer are not expected to finish until 2025, Roth said headcount reductions in the pharma commercialization unit will largely be done at the beginning of the fourth quarter.   A new operating model As a result of the streamlining, “the span of coaching for every leader in the organization is going to double and, in some cases, triple,” Roth told Fierce Pharma on the sidelines of the American Society of Clinical Oncology annual meeting in Chicago in late May. “One of the tenets of DSO is, managers need to be less involved in the day-to-day,” Roth said. “Our role is as visionaries, architects, catalysts and coaches.” Within Bayer’s pharma unit, staff responsibilities across late-stage development, registration, commercialization and lifecycle management are being reshaped, with regulatory and development functions shifting over to the R&D organizations. For commercialization, Bayer previously had product sales teams and parallel functional teams, which may have operated on separate strategies. Now, those functions, such as marketing, market access, medical affairs and patient advocacy sit unified in the global capabilities group—instead of being dispersed across each product. Under that model, Roth explained, the product teams will set goals, and then everyone else, including Roth herself, will provide resources in service of those goals. The new DSO model still needs some honing, but Bayer expects to install people in their new jobs and functions by the end of the year across the company, Roth said.  “The beauty of this system is, we’re not perfecting it before we start,” Roth said. “We’re getting to a good place where we can start to experiment and go. And we will learn and adjust as we go.” To help test out DSO, Bayer has designated several “front-runner” teams. “The front runners have been really critical in helping us do that, because their job was to try out the new system—we did our best to completely leave them alone—to let us know what’s working to support them and what’s not working, and then feed real-time learnings back into the organization,” Roth said. The team for Bayer’s prostate cancer drug Nubeqa is one of the front-runners groups. Bayer has pegged the androgen receptor inhibitor to reach peak sales of more than €3 billion a year. Bayer is trying to expand Nubeqa’s reach in part through the phase 3 ARANOTE trial in metastatic hormone-sensitive prostate cancer. The study reached primary completion on June 7, according to clinicaltrials.gov. A Bayer spokesperson said the company plans to announce the topline results soon. While preparing for potential regulatory filings for ARANOTE, the team identified many unnecessary processes from the old practice, including around 80 tables that would have previously been produced. Eliminating those processes will save time and costs, Roth said. DSO is also coming into play with Bayer’s possible launch of the hot flash drug elinzanetant, which has three positive phase 3 trials in the bag and an FDA filing on the horizon. The new model has allowed the elinzanetant staffers to tap into digital resources that traditionally have not been dedicated to a specific product team, Roth said. Novel channel marketing resources were brought in “because they see this launch as not so much the traditional boots-on-the-ground, reach-and-frequency, face-to-face with physician, but much more patient engagement and much more policy engagements,” Roth said. Direct-to-consumer patient marketing will be critical for elinzanetant launch, Roth added. Bayer wants to empower women to have an open dialogue with doctors about their symptoms and potential treatment options, and to make sure medical policies are in place so that patients can have access to the meds. Bayer is evaluating DSO system in 90-day cycles. According to Roth, employees are getting the hang of the new model and need no more convincing. “We are going to have to get our hands dirty and let teams really struggle through some of these things before we see what kind of adjustments we need to make,” Roth said. “What I am very focused on achieving between now and the end of the year is, as people complete multiple 90-day cycles, I will be listening and checking to make sure that it feels different for employees. They feel empowered. They feel like there are fewer barriers to getting the job done. They feel like they’re closer to the customer.”   Bayer’s oncology ambition: ‘A moving target’ Roth had experience working in women’s health and cardiometabolic diseases. But before she came to lead Bayer’s entire pharma commercial operations, she had spent nearly two decades in oncology, including at GSK, Novartis and Bristol Myers Squibb. Last year, Bayer laid out an ambition to reach $10 billion in revenue from cancer drugs by 2030 and to become a top 10 oncology player. It’s a bold target considering none of the pharma division’s top 3 products last year were in oncology, while Nubeqa is expected to hit above $1 billion sales this year. So at last year’s ASCO annual meeting, Roth told Fierce Pharma that Bayer would need a “midsize acquisition” to reach its revenue goal. This time around, Roth argued that there’s no magic formula on how to achieve an ambitious target in pharma, and that a midsize deal may not be absolutely necessary. “I would not so much focus on the $10 billion anymore,” Roth said during this year’s ASCO conference. “The goal is to become a top oncology player, and it’s a moving target anyway.” “All we need, to be quite honest with you, is [for] one of the assets from Vividion—one of the assets in our pipeline—to be our next $2-to-$3-billion drug,” she said hypothetically. “And all of a sudden, the picture changes.” Bayer acquired Vividion Therapeutics in 2021 and made the discovery engine an independently operating subsidiary. In oncology, the unit is working on candidates to inhibit NRF2 and STAT3, and it has an anti-WRN program in collaboration with Roche. But all of those programs are in early-stage testing and currently don’t have data in their clinical profiles. Roth also pointed to Bayer’s HER2 program, a reversible tyrosine kinase inhibitor coded BAY 2927088, which recently received an FDA “Breakthrough Therapy” designation in previously treated HER2-mutated non-small cell lung cancer. It also has a new PSMA-targeted radioligand therapy coded BAY 3563254. But those are also in phase 1 development. Compared with other therapeutic areas, Bayer’s oncology pipeline is composed of newer assets that are relatively unproven. In women’s health, the company is looking to introduce elinzanetant soon. And it just bought European rights to BridgeBio’s near-to-market heart disease drug acoramidis. But in oncology, it has no phase 2 or phase 3 therapeutic programs in sight for novel molecules, while Nubeqa was first introduced about five years ago.   The Bayer pharma team has had discussions with CEO Anderson—a pharma veteran—about the need to balance between early-stage and later-stage assets in the oncology pipeline, Roth said. For one thing, the DSO model is expected to advance early-stage programs faster. “The core of the strategy is really to continue investing and filling the funnel,” Roth said. As for M&A deals, Roth argued that the ongoing restructuring wouldn’t impair Bayer’s ability to pursue external transactions in oncology, pointing to the BridgeBio deal. But the drugmaker simply hasn’t identified the right target. “[If] we find the right one, I’m fairly optimistic that we’ll be successful if that’s what we want to bring in,” Roth said. “We’ve looked at a lot of things that have transacted recently and just decided for one reason or another that they weren’t the right deal for us.”