Verismo Therapeutics recently announced it has received Fast Track designation from the US Food and Drug Administration (FDA) for its investigational drug SynKIR-110. SynKIR-110 is being investigated 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-110.1
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 the first product to use Verismo Therapeutics’ KIR-CAR platform, which is a dual-chain CAR T cell therapy. It has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging solid tumor environments.