NATICK, Mass., May 17, 2021 /PRNewswire/ — AffyImmune Therapeutics, Inc., a clinical stage biotechnology company finding safe, effective ways to use CAR T cells against solid cancers, announced today that the US Food and Drug Administration (FDA) granted Fast Track designation to its lead compound, AIC100, for the treatment of anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer. The company previously received Orphan Drug designation for AIC100.
The FDA’s Fast Track designation is designed to facilitate development and expedite review of drug candidates to treat serious conditions and address an unmet medical need. Receipt of Fast Track designation provides grounds for more frequent interaction with the FDA throughout the drug development process for more rapid advancement, earlier approval and access for patients.
“We are pleased to have received Fast Track designation for our first-in-human CAR T cell product currently being tested in patients with refractory thyroid cancer,” remarked Eric von Hofe, President and COO of AffyImmune. “It highlights the unmet need in treating refractory solid tumors and points to the potential of AIC100 to address that need. We look forward to a close relationship with the FDA to expedite development and future approvals.”
In connection with the approval, AffyImmune has made available its expanded access policy for AIC100 at https://www.affyimmune.com/expanded-access-policy.
About AffyImmune Therapeutics, Inc.
AffyImmune is realizing the potential of cancer immunotherapy by extending the anti-cancer activity of CAR T cell therapy to solid tumors. AffyImmune’s proprietary technology allows fine-tuning of the affinity of CAR T cells to reduce toxicity and a tracking system to allow for real-time localization of CAR T cells after administration to patients. The company was founded in 2016 and in 2020 began enrolling patients in its Phase 1 trial to treat advanced thyroid cancer.
Eric von Hofe
AffyImmune Therapeutics, Inc.