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Sensei Biotherapeutics Announces Initiation of Combination Arm for Phase 1/2 Clinical Study of SNS-101 with Regeneron’s Libtayo®
- Eleven patients enrolled overall in trial to date, with enrollment progressing faster than anticipated - - Monotherapy arm has advanced to a fourth cohort,
About this update from Sensei Biotherapeutics, Inc.
[{"type":"text","content":"- Eleven patients enrolled overall in trial to date, with enrollment progressing faster than anticipated - - Monotherapy arm has advanced to a fourth cohort, with initial monotherapy PK and safety data expected in the fourth quarter of 2023 and topline monotherapy data expected in 2024 - - New guidance for initial combination PK and safety data expected in the first quarter of 2024, with preliminary anti-tumor activity data expected in 2024 - BOSTON, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today 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. “We are pleased with the rapid enrollment of our clinical trial and are excited to evaluate SNS-101 as a combination therapy earlier than anticipated,” said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. “Sensei is now treating patients at a dose significantly higher than any VISTA antibody for which clinical data have been reported, while dosing less frequently at a rate of once every three weeks. We believe these important differentiators underscore the vast potential of SNS-101 to treat patients with solid tumors.” As a result of faster enrollment than anticipat...