NEW YORK – Verismo Therapeutics on Tuesday said it will begin evaluating SynKIR-110, an autologous cell therapy, in a Phase I clinical trial involving patients with mesothelin-expressing ovarian cancer, cholangiocarcinoma, and mesothelioma.
The US Food and Drug Administration has cleared Verismo's investigational new drug application for the cell therapy, which is similar to CAR T-cell therapy, but involves attaching an NK cell membrane anchor to the cell's surface receptor. This approach allows cells to "rest" when they are not bound to cancer cells, which in theory should avoid the eventual cell exhaustion that hampers the long-term efficacy of many cell therapies.
According to Verismo CEO Bryan Kim, SynKIR-110 has demonstrated efficacy in mouse models with no added safety concerns.
The firm's first-in-human trial, dubbed STAR-101, is designed to evaluate SynKIR-110's safety, tolerability, and preliminary efficacy. University of Pennsylvania spinout Verismo is aiming to begin enrolling patients onto the trial at UPenn's hospital during the first quarter of 2023.