RARE Daily

FDA Grants Fast Track Designation to Verismo Therapeutics for SynKIR-110 to Treat Mesothelioma

April 6, 2023

Rare Daily Staff

The U.S. Food and Drug Administration granted Verismo Therapeutics Fast Track designation for its investigational new drug, SynKIR-110, for the treatment of patients with the rare cancer mesothelioma.

Mesothelioma is a rare type of cancer that affects the lining of the chest or abdominal cavities. More than 2,000 cases of this aggressive cancer are diagnosed in the U.S. each year. While life expectancy can differ depending on a variety of factors, such as type and location of the disease, stage at diagnosis, and general patient health, overall, patients usually survive only four to eighteen months after diagnosis.

SynKIR-110 is a next generation approach to cell therapy targeting solid tumors, and the first product to use the novel KIR-CAR platform, a modified NK-like receptor designed to improve persistence and efficacy against aggressive solid tumors.

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.

Verismo 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.

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