Company: SNSE
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0000950170-25-064525
Chunk: 5

Company: Sensei Biotherapeutics, Inc.
Filing Date: 2025-05-06
Form: 10-Q
Item: Item 2
Chunk 5
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 clinical trial designs targeted to well-defined patient populations. 

We currently have one investigational product candidate, solnerstotug, in clinical development, and three preclinical product candidates.

•Solnerstotug (formerly referred to as SNS-101) is our conditionally active monoclonal antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T-cell activation). 

oIn May 2023, we initiated a first-in-human Phase 1/2 open-label, multi-center, dose escalation and expansion trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of solnerstotug as monotherapy and/or in combination with cemiplimab in patients with advanced solid tumors. 

oOn March 27, 2025, we disclosed clinical data from the dose expansion portion of the clinical trial, showing favorable activity in patients with PD-(L)1 resistant “hot” tumors. 

oAs of May 1, 2025 an aggregate of 97 patients have been dosed in the Phase 1 portion of the clinical trial, consisting of 34 patients in the dose escalation cohort and 63 patients in the dose expansion cohort. The 63 patients in the dose expansion cohort consist of:

▪10 microsatellite stable (MSS) CRC patients in the monotherapy arm; and 

▪53 patients in the cemiplimab combination arm, consisting of 10 MSS CRC patients and 43 PD-(L)1 resistant "hot" tumor patients.  

oEnrollment in the Phase 1 portion of the clinical trial is now complete, and we expect to present updated clinical data from the dose expansion cohort by the end of 2025.

oSubject to our ability to raise sufficient additional capital, we are planning to initiate a Phase 2 trial of solnerstotug in the first quarter of 2026, with the trial design and patient selection strategies to be informed by the ongoing dose expansion portion of the trial.

•SNS-102 is our conditionally active monoclonal antibody targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4), an immune checkpoint often expressed on macrophages.