Penn Spinout Verismo Therapeutics Receives FDA Clearance of Investigational New Drug Application for SynKIR-110™, a KIR-CAR T Cell Immunotherapy Candidate

Penn Spinout Verismo Therapeutics 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 in August 2022.

Shortly after, on September 21, 2022, Verismo announced that their IND application was approved, giving them the green light to begin the Phase 1 clinical trial. Verismo plans to begin enrolling patients in the first quarter of 2023 at the initial clinical site, the Hospital of the University of Pennsylvania.

This first-in-human trial, STAR-101 (SynKIR T cell Advanced Research), will assess safety, tolerability, and preliminary efficacy of SynKIR-110 in patients with mesothelin expressing ovarian cancer, cholangiocarcinoma and mesothelioma, diseases which have low survival rates and present an urgent need for successful treatment options.

STAR-101 will mark the first-in-human study for SynKIR T cells, a next generation approach to cell therapy that targets solid tumors powered by the KIR-CAR platform. Its unique, multi-chain KIR-CAR construct reduces T cell exhaustion through the natural on-and-off switch that allows the cells to rest when not bound to the tumor. It also offers enhanced surface stability to improve the performance of the cells in the harsh microenvironment of solid tumors.

“SynKIR-110 is the first product to use the novel KIR-CAR platform. Our technology incorporates a natural on/off switch that allows KIR-CAR T cells to rest when not exposed to tumor antigens, as well as providing an enhanced cell-surface stability of the KIR-CAR,” said Dr. Laura Johnson, CSO of Verismo. “These enhancements will allow KIR-CAR T cells to better cope with the harsh tumor microenvironment of solid tumors and, potentially, lead to better outcomes for our patients.”

To read more about Verismo’s IND approval, go here.

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