On April 5, 2023 Verismo Therapeutics, a clinical-stage CAR T company, Penn spinout, and pioneer of the novel KIR-CAR platform technology, reported that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its investigational new drug, SynKIR-110, for the treatment of patients with mesothelioma (Press release, Verismo Therapeutics, APR 5, 2023, View Source [SID1234629889]).
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Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and address unmet medical needs, thus enabling drugs to reach patients sooner. Clinical Programs with Fast Track designation may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.
SynKIR-110 is an investigational new drug for the treatment of mesothelin-expressing mesothelioma, cholangiocarcinoma and ovarian cancer. Verismo Therapeutics is conducting a Phase 1 multicenter clinical trial in these tumor types to evaluate the safety, feasibility and anti-tumor activity of the SynKIR-110 (ClinicalTrials.gov Identifier: NCT05568680).
"We are thrilled to receive Fast Track designation from the FDA," said Dr. Bryan Kim, DMD, Co-Founder and CEO of Verismo Therapeutics. "This designation is an important milestone in our efforts to bring this potentially life-saving drug to patients who are in need of new treatment options."
Verismo Therapeutics is committed to developing innovative treatments for patients with serious and life-threatening conditions using its novel KIR-CAR platform.
For more information about SynKIR-110, please visit www.verismotherapeutics.com.
About the KIR-CAR Platform
The KIR-CAR platform is a dual-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging solid tumor environments. DAP12 acting as a novel costimulatory molecule for T cells, aids additional T cell stimulating pathways, further sustaining chimeric receptor expression and improving KIR-CAR T cell persistence. This continued T cell function and persistence can lead to ongoing regression of solid tumors in preclinical models, including those refractory to traditional CAR T cell therapies. Furthermore, the KIR-CAR platform can be combined with many additional emerging technologies, such as in vivo gene engineering, advanced cell manufacturing and reprogramming, combinational therapies, and even allogeneic cellular therapies to provide the next-generation multimodal targeted immunotherapy for patients in need.