NEW YORK – Verismo Therapeutics said on Friday that it has submitted an investigational new drug application to the US Food and Drug Administration for its autologous cell therapy SynKIR-110 for mesothelin-expressing ovarian cancer, mesothelioma, and cholangiocarcinoma.
Should the FDA clear the IND, University of Pennsylvania spinout Verismo plans to begin a Phase I clinical trial, dubbed STAR-101, during the first quarter of 2023.The trial would be the first to evaluate the firm's KIR-CAR platform, which engineers patients' immune cells to have the same cell-targeting elements — antibody fragment surface receptors — as CAR T-cells but with a membrane anchor found on natural killer cells to better infiltrate solid tumors.
The KIR-CAR technology, which Verismo describes as a modified NK cell receptor, is meant to improve the cells' persistence in patients, since traditional CAR T-cells often fatigue quickly when trying to infiltrate solid tumor membranes. In preclinical studies, the platform has been shown to maintain antitumor T-cell activity in solid tumor environments.