Sensei Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SNS-101, a conditionally active VISTA-blocking antibody, paving the way for the Company to conduct a Phase 1/2 clinical trial in patients with solid tumors. The Phase 1/2 clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101 as both a monotherapy and in combination with Regeneron's PD-1 inhibitor Libtayo(R) (cemiplimab) in solid-tumor cancer patients. The Phase 1 dose escalation portion of the clinical trial will be followed by an expansion Phase 2 in selected patient populations once a recommended Phase 2 dose is determined.

SNS-101 will be administered as an intravenous infusion once every three weeks. Sensei expects to dose the first patient in mid-2023.