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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 .

AffyImmune Therapeutics said Thursday its autologous CAR-T cell therapy AIC100 is the first to achieve a complete response in a patient with a solid tumour. The Phase I trial data, shared ahead of a presentation at the American Society of Clinical Oncology (ASCO) annual meeting, suggest the cell therapy could be a tolerable and efficacious option to treat thyroid cancer.The study is enrolling patients with either anaplastic thyroid cancer (ATC), the most aggressive form of the disease, or poorly differentiated thyroid cancer (PDTC) to receive one of three dose levels of AIC100 – either 1x 107, 1 x 108, or 5 x 108 cells – which is an ICAM-1 targeting and affinity-tuned LFA-1 binder CAR-T.In six evaluable patients who received either the second or third dose levels, the cell therapy led to an overall response rate (ORR) of 33%. The figure comprises a partial response in a patient with ATC who received the medium dose, and a durable metabolic complete response in a patient with ATC who received the high CAR-T dose and was able to go off all chemotherapy.The disease control rate, defined as ORR plus stable disease, was 67% in the six patients.Across all 10 evaluable patients, 60% developed grade 1/2 cytokine release syndrome. No patients experienced immune effector cell-associated neurotoxicity syndrome or another serious adverse event related to AIC100.“We believe AIC100 has the potential to overcome current barriers to CAR T, and ultimately establish a new paradigm for patients with solid tumour cancers,” AffyImmune CEO Matt Britz said.ASCO Daily Digest – your go-to-source for the key developments emerging from this year's American Society of Clinical Oncology (ASCO) annual meeting. Exclusively for PLUS subscribers – sign up here!