Company: SNSE
Filing Date: 2025-08-05
Form Type: 10-Q
Source: 0000950170-25-103101
Chunk: 5

Company: Sensei Biotherapeutics, Inc.
Filing Date: 2025-08-05
Form: 10-Q
Item: Item 2
Chunk 5
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 we are developing highly selective therapeutics designed to disable immunosuppressive signals or activate immunostimulatory signals selectively in the tumor microenvironment. Our strategy is to generate novel product candidates that incorporate next-generation technologies or approaches. We plan to efficiently develop these product candidates by incorporating state-of-the-art biomarker approaches and mechanistic understanding into 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 64 patients in the dose expansion cohort. The 64 patients in the dose expansion cohort consist of:

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

▪54 patients in the cemiplimab combination arm, consisting of 10 MSS CRC patients and 44 PD-(L)1 resistant “hot” tumor patients. 41 out of 44 patients in the “hot” tumor cohort had received and progressed on a prior PD-(L)1 inhibitor.

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, including 6-month progression free survival, by the end of 2025.

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