Sensei Biotherapeutics’ SNS-101 shows potential efficacy in Phase 1/2 trial

Sensei Biotherapeutics (SNSE) reported encouraging clinical data from the dose escalation portion of its Phase 1/2 trial of SNS-101, a conditionally active, human monoclonal antibody targeting the immune checkpoint VISTA. The dose escalation portion of the Phase 1/2 clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101 both as monotherapy and in combination with Regeneron’s (RGNE) PD-1 inhibitor Libtayo in patients with advanced solid tumors with primary or acquired PD-1 therapy resistance. SNS-101 demonstrated preliminary evidence of promising clinical activity in multiple tumor types. SNS-101 demonstrated a potentially best-in-class pharmacokinetic profile with linear elimination kinetics and dose-proportional increases in exposure, supporting once every three week dosing. The data are consistent with lack of target-mediated drug disposition, which has been observed in non-conditionally active anti-VISTA antibodies. SNS-101 was well tolerated alone and in combination with cemiplimab, with no dose-limiting toxicities observed. Patient enrollment is advancing in the dose expansion portion of the Phase 1/2 study. The company expects to report initial data from the dose expansion cohorts and to hold an end-of-Phase 1 meeting with the FDA by the end of 2024.