AffyImmune Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for AIC100 in Recurrent Anaplastic Thyroid Cancer

• RMAT designation follows FDA’s review of available preliminary clinical evidence that AIC100 has the potential to address unmet medical need in recurrent anaplastic thyroid cancer (ATC)

• RMAT designation enables increased dialogue with the FDA to support the potential expedited development and review of AIC100 in clinical evaluation for ATC

NATICK, Mass., July 23, 2024--(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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240723305679/en/

Contacts

Kimberly Ha
KKH Advisors
kimberly.ha@kkhadvisors.com
917-291-5744