Sensei Biotherapeutics, Inc. announced that the first patient has been dosed in its Phase 1/2 clinical trial evaluating SNS-101 for the treatment of advanced solid tumors. SNS-101 is a conditionally active, human monoclonal IgG1 antibody, designed to selectively block the immune checkpoint VISTA in the tumor microenvironment, which acts as a suppressor of T cells by binding the receptor PSGL-1. The multi-center Phase 1/2 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of SNS-101 as both monotherapy and in combination with Regeneron's PD-1 inhibitor Libtayo(R) (cemiplimab) in patients with advanced solid tumors. Preclinical data showing SNS-101's safety and tolerability profile and linear elimination kinetics support a starting dose of 0.3 mg/kg for the Phase 1 monotherapy dose escalation portion of the trial, substantially higher than other anti-VISTA antibodies.

Sensei intends to begin the Phase 1 combination dose escalation portion of the trial., based on emerging clinical data from the monotherapy dose escalation. The Company expects to report topline monotherapy data and initial combination therapy data from Phase 1 in 2024. Once the recommended Phase 2 dose is determined in Phase 1, the Phase 2 cohort expansion portion of the study will begin in selected patient populations.