Penn spinout company Verismo Therapeutics announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) requesting approval to initiate its first-in-human Phase 1 clinical trial of its KIR-CAR T-cell immunotherapy drug SynKIR-110. Pending regulatory approval, Verismo plans to use the drug in patients with mesothelin-expressing ovarian cancer, mesothelioma and cholangiocarcinoma.
If approved, the goal is to initiate the STAR-101 (SynKIR T cell Advanced Research) trial in Q1 2023. This trial will mark the first-in-human study of the KIR-CAR platform technology, which harnesses the power of natural killer (NK) cells in genetically re-engineered CAR T-cells and aims to transform the treatment of solid tumors.
“Initiation of the STAR-101 clinical trial based on the KIR-CAR platform technology is a momentous company milestone that represents years of research from industry pioneers and the tremendous focus and commitments of the Verismo team,” said Dr. Bryan Kim, CEO of Verismo. “We are thrilled to advance our treatment one step closer to helping patient populations with severely unmet medical needs.”
To learn more about Verismo and their Investigational New Drug application, read here.