Company: SNSE
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0000950170-25-046338
Chunk: 5

Company: Sensei Biotherapeutics, Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1
Chunk 5
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Overview 

We are a clinical-stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients. Through our TMAb™ (Tumor Microenvironment Activated Biologics) platform, 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 believe there are multiple opportunities and significant potential for patients within our product pipeline. Each program, summarized in the chart below, is derived from our TMAb platform.

•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. 

oIn May 2024, we presented clinical data from the dose escalation portion of the trial at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Data were presented from a total of 34 patients who received solnerstotug once every 3 weeks, with 16 patients in the monotherapy arm and 18 patients in the combination arm. 

oAs of March 17, 2025 an aggregate of 60 patients have been dosed in the Phase 1 dose expansion portion of the clinical trial, including:

▪40 patients with tumor types that typically respond to PD-1 monotherapy, which we refer to as “hot tumors,” including Non-Small Cell Lung Cancer (NSCLC), Head and Neck (H&N) Cancer, Melanoma, Renal Cell Carcinoma (RCC), Merkel Cell Carcinoma (MCC), MSI-High (MSI-H) Colorectal Cancer (CRC), and other tumor types, with all patients receiving a combination of solnerstotug (3 mg/kg or 15 mg/kg) and cemiplimab; and