AffyImmune’s AIC100 Gains the US FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Recurrent Anaplastic Thyroid Cancer
Shots:
- The US FDA has granted RMAT designation to AIC100 (ICAM-1 targeting & affinity-tuned LFA-1 binder CAR-T cell therapy) for treating recurrent anaplastic thyroid cancer (ATC)
- The designation was based on interim data, highlighted at ASCO 2024, from first 10 patients involved in P-I trial evaluating the safety, tolerability & RP2D of AIC100 to treat r/r poorly differentiated thyroid cancer (PDTC) & ATC
- As of the data cut off, results in 10 patients receiving AIC100 at 3 dose levels showed no DLTs with MTD not attained, DCR of 67% and ORR of 33% in DL2 (100 million CAR T cells) & DL3 (500 million CAR T cells) with 1 durable PR (DL2) & 1 ongoing durable mCR (DL3)
Ref: Businesswire | Image: AffyImmune
Related News:- Eli Lilly Receives the US FDA’s Approval for Retevmo (Selpercatinib) to Treat Thyroid Cancer or Solid Tumors
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
