Affyimmune Therapeutics, Inc.

NATICK, Mass.--( BUSINESS WIRE )-- AffyImmune Therapeutics , a clinical-stage biotechnology company committed to developing its novel, first-in-class ICAM-1 targeting chimeric antigen receptor (CAR) T cell therapy for solid tumors, today announced the appointment of Rick Rutter, Ph.D., and Jorge Nieva, M.D., to its Board of Directors. The addition of these distinguished leaders in clinical development and manufacturing strengthens AffyImmune’s commitment to advancing its AIC100 program in advanced thyroid cancers and non-small cell lung cancer (NSCLC). “AffyImmune is nearing completion of our Phase 1 trial and advancing toward determining the recommended Phase 2 dose in thyroid cancers, while defining the path for NSCLC. Expanding the board to include Rick and Jorge cannot be timelier. Not only will they bring decades of experience in their respective domains, they will also strengthen the board’s ability to steer and govern strategic matters. The management team and board will work closely together to deliver lifesaving cancer therapeutics for patients who currently have no effective treatments,” said Simone Song, Chairwoman, AffyImmune. “We are thrilled to welcome Rick and Jorge to our board at such an important time for AffyImmune, as we advance our CAR T cell product candidate AIC100 towards registrational studies for advanced thyroid cancers, and plan for our Phase 1 trial for non-small cell lung cancer,” said Daniel Janse, CEO, AffyImmune. “Their insight and counsel as members of our board will be invaluable as we validate a commercially robust CAR T cell manufacturing process and focus our NSCLC clinical strategy on patients that will receive the greatest benefit from AIC100.” Rick Rutter, Ph.D., brings over 40 years of experience in the pharmaceutical and biotech industries, with a deep expertise in CMC regulatory strategy and drug product manufacturing. Dr. Rutter has held several key positions, including Executive Vice President of Biotherapeutics Pharmaceutical Sciences at Pfizer. He currently serves as an expert consultant and advises both public and private companies on CMC and supply chain management. Jorge Nieva, M.D., is Associate Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California and Section Head of Lung and Head/Neck Tumors at the Norris Comprehensive Cancer Center. He served as a standing member of the U.S. Food and Drug Administration’s Oncology Drug Advisory Committee from 2021-2024. Dr. Nieva’s clinical research teams have been recognized for excellence in the conduct of clinical trials from the National Cancer Institute and the American Association of Oncology Research. “I am delighted to join AffyImmune’s Board and to work with the management team to bring industry-best CMC and supply chain practices, and ready AIC100 for registrational trials and commercial launch,” said Dr. Rutter. “I look forward to sharing my insights and supporting the company as it delivers timely and high-quality autologous CAR T cell products to advanced thyroid cancer and NSCLC patients with significant unmet medical need.” “Joining AffyImmune’s Board of Directors is an exciting opportunity to contribute to the expansion of AIC100 beyond advanced thyroid cancers, into larger indications such as NSCLC,” said Dr. Nieva. “I look forward to working alongside such a dedicated team to drive forward their innovative CAR T therapies. AffyImmune’s technology has the unique potential to broadly revolutionize treatment for patients with solid tumors.” About AffyImmune Therapeutics AffyImmune is a clinical-stage biopharmaceutical company committed to developing a first-in-class, ICAM-1 targeting and affinity-tuned LFA-1 binder CAR T therapy to transform the lives of patients with advanced solid cancers. The Company’s proprietary technology utilizing ICAM-1/LFA-1 interaction can potentially address the critical CAR T challenges such as toxicity, antigen loss, T-cell trafficking and exhaustion, while also allowing in vivo tracking of the CAR T cells. Its lead candidate, AIC100, is currently in a Phase 1 study to treat patients with advanced thyroid cancers, including advanced differentiated thyroid cancer and anaplastic thyroid cancer. AffyImmune is developing a focused pipeline in ICAM-1-positive cancers with high unmet medical need. AffyImmune is based in Natick, MA. For more information, visit www.affyimmune.com .

NATICK, Mass.--( BUSINESS WIRE )-- AffyImmune , a clinical-stage biotechnology company committed to developing novel, first-in-class chimeric antigen receptor (CAR) T cell therapies, announced today the designation of Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (FDA) for its CAR T-cell product candidate, AIC100 as a potential treatment for patients with recurrent anaplastic thyroid cancer (ATC), the most aggressive form of the disease. “We believe this important recognition from the FDA further supports the therapeutic potential of AIC100 to change the current treatment paradigm in advanced thyroid cancer and potentially other forms of aggressive solid tumors,” said Daniel Janse, Ph.D., CEO at AffyImmune. “RMAT designation was granted following the FDA’s review of safety and efficacy data from the first ten patients dosed with AIC100 in our Phase 1 study. We believe the RMAT designation reinforces the potential ability of AIC100 to meet the high unmet medical need in recurrent ATC, an aggressive disease where a standard of care is currently not available.” RMAT designation was designed to expedite the development and review of regenerative medicine therapies. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious condition, and preliminary clinical evidence indicates the therapy has the potential to address unmet medical needs for the disease. Sponsor companies receiving RMAT designation can benefit from increased interactions with the FDA involving senior managers, with the goal of expediting drug development. “We remain focused on advancing the development of AIC100 for patients and families living with this devastating cancer,” said Sonal Gupta, M.D., Ph.D., Senior Vice President and Head of Clinical Development. “Receiving RMAT designation helps facilitate this goal by enabling increased dialogue with the FDA to expedite our development plan for our affinity-tuned CAR T therapy. We look forward to working closely with the FDA and other regulatory agencies as we continue to advance this program.” At ASCO 2024, AffyImmune reported interim results from their Phase 1 study evaluating the safety and efficacy of AIC100, an ICAM-1 targeting and affinity-tuned LFA-1 binder CAR T-cell therapy, in patients with advanced thyroid cancer. Notably, a metabolic complete response was achieved in one patient with ATC, the most aggressive form of the disease. For more information about the Phase 1 study, visit www.clinicaltrials.gov (NCT04420754). About AffyImmune Therapeutics AffyImmune is a clinical-stage biopharmaceutical company committed to developing a first-in-class, ICAM-1 targeting and affinity-tuned LFA-1 binder CAR T therapy to transform the lives of patients with advanced solid cancers. The Company’s proprietary technology utilizing ICAM-1/LFA-1 interaction can potentially address the critical CAR T challenges such as toxicity, antigen loss, T-cell trafficking and exhaustion, while also allowing in vivo tracking of the CAR T cells. Its lead candidate, AIC100, is currently in a Phase 1 study to treat patients with advanced thyroid cancers including advanced differentiated thyroid cancer and ATC. AffyImmune is developing a focused pipeline in ICAM-1-positive cancers with high unmet medical need. AffyImmune is based in Natick, Massachusetts. For more information, visit www.affyimmune.com .

None  Welcome to this week's Chutes & Ladders, our roundup of significant leadership hirings, firings and retirings across the industry. Please send the good word—or the bad—from your shop to Gabrielle Masson and it will be featured here at the end of each week. Gilead's CMO bids adieu Gilead Sciences is saying goodbye to its chief medical officer after Merdad Parsey, M.D., Ph.D., announced intentions to leave the company early next year. As Gilead hunts for a successor, Parsey will continue to serve as CMO until the first quarter of 2025. The outgoing exec also plans to support the transition of his replacement over the next several months, Gilead said in a release. Parsey has been at Gilead for five years, joining in November 2019. During his stint at the company, Parsey helped lead the growth of Gilead’s development organization, including the establishment of Gilead’s cancer pipeline and the rollout of the COVID-19 treatment Veklury. The oncology portfolio has suffered some setbacks in recent months, however, with Gilead dropping work on magrolimab in April despite the anti-CD47 monoclonal antibody being the centerpiece of its $4.9 billion acquisition of Forty Seven. “It has been a privilege to lead the development team, especially as we have worked to deliver transformative medicines for people with HIV, COVID-19 and cancer,” Parsey said in a statement. “I am profoundly excited about the work we have done to build a strong, diverse clinical pipeline that has tremendous potential to deliver on our commitment to improve health for people around the world.” Release  Cassava execs are out Austin, Texas-based Cassava Sciences is searching for a permanent leader in the wake of the resignation of CEO Remi Barbier.  The Alzheimer's-focused company, which is no stranger to controversy, has found an interim helmsman in Richard Barry, who has been tapped as executive chairman of the board and Cassava’s principal executive officer, effective immediately. Barry has served as director of Cassava since June 2021 and has also served as director of Sarepta Therapeutics since June 2015. At the same time, the company will search for a new permanent CEO, Cassava said in a press release. Barbier is set to remain onboard with Cassava until Sept. 13 in a non-executive capacity, without duties or responsibilities. In addition, Lindsay Burns, Ph.D., SVP of neuroscience, has agreed to step down from her role at Cassava. After being separated from the company for a year, Burns will offer consulting services to Cassava, providing information and support for scientific research and obtaining approval for the company’s products. Release  I-Mab loses CEO, finds new board chair I-Mab also found itself in need of a new CEO this week, after Raj Kannan stepped down from his post on July 15. Kannan is sticking around as an advisor until July 31, while I-Mab hunts for a permanent successor. Sean Xi-Yong Fu will be stepping up to become interim helmsman and a member of the board of directors. Fu is also an operating partner of ABio-X, which is an incubation platform for life sciences companies. Before joining ABio-X, Fu was co-founder and CEO of RVAC Medicines, which utilized an mRNA platform. Meanwhile, after a six-year run as a member of I-Mab’s board of directors, Wei Fu is stepping up to the captain’s seat. Fu, who has served on I-Mab’s board since June 2018, is succeeding Pamela Klein, M.D., as chairman of the board. Klein is stepping down after taking on the role on an interim basis. Release  > Jonathan Appleby, Ph.D., has been appointed chief scientific officer of Mogrify Limited, a regenerative medicine company. He was previously executive director and CSO of the Cell and Gene Therapy Catapult and has held leadership roles at GSK, including CSO for cell and gene therapy in GSK’s Rare Diseases Unit. Release > Rectify Pharmaceuticals is appointing Bharat Reddy, Ph.D., as chief business officer. Reddy most recently served as a vice president of strategy and business development at Kelonia Therapeutics and has also served in leadership at Catamaran Bio and bluebird bio. Release > Daniel Janse, Ph.D., has been named president and CEO of AffyImmune. Janse is joining from Northpond Ventures, where he was managing director. He has also held leadership positions at Arbor Biotechnologies, Juno Therapeutics, Johnson & Johnson Innovation Center, Inventages Venture Capital and McKinsey & Company. Release > Nadir Mahmood, Ph.D., will join Nkarta as president, sharing executive leadership responsibilities with Paul Hastings, who continues as CEO. David Shook, M.D., is now chief medical officer, head of research and development. Mahmood was previously the CEO of Rezo Therapeutics and also had a past life at Nkarta as chief financial and business officer. Release > Avalo Therapeutics is appointing Mittie Doyle, M.D., as chief medical officer. Doyle joins from Aro Biotherapeutics, where she served as chief medical officer since 2021. She has also had senior roles at CSL Behring, Shire Pharmaceuticals, Flexion Therapeutics and Alexion Pharmaceuticals. Release > Rezo Therapeutics is appointing Cristiana Guiducci, Ph.D., as chief scientific officer. Guiducci previously served as senior vice president of immunology and oncology research at Nurix Therapeutics. She also spent more than 13 years at Dynavax Technologies. Release