Sensei Biotherapeutics, Inc. announced that the first patient has been dosed in the combination therapy arm of the Phase 1/2 clinical trial for SNS-101, a conditionally active, human monoclonal antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation). This initial cohort of patients will receive a dose of 3 mg/kg of SNS-101 and a flat dose of Regeneron?s PD-1 inhibitor Libtayo® (cemiplimab) at 350 mg. Additionally, the Company announced that the fourth cohort of the monotherapy arm at a dose of 10 mg/kg has been fully enrolled.

The multi-center Phase 1/2 clinical trial is a dose escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of SNS-101 as both a monotherapy and in combination with Libtayo® in patients with advanced solid tumors. To date 10 patients have been treated in the monotherapy arm, consisting of four cohorts receiving SNS-101 treatment at 0.3, 1, 3, or 10 mg/kg. Sensei expects to report initial pharmacokinetic and safety monotherapy data in the fourth quarter of 2023, and topline monotherapy data in 2024.

As a result of faster enrollment than anticipated, Sensei now expects to report initial combination pharmacokinetic and safety data in First Quarter 2024 with preliminary anti-tumor activity data in 2024.