Exhibit 99.1
Sensei Biotherapeutics Reports First Quarter 2025 Financial Results and Updates on Clinical Progress
- Favorable clinical data in PD-(L)1 resistant patients -
- Dose expansion enrollment complete with full data expected by year-end 2025 -
- Cash runway into the second quarter of 2026 -
BOSTON, MA May 6, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company
focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the first quarter 2025, and provided corporate updates.
This was a breakthrough quarter for Sensei, said John Celebi, President and CEO. We observed favorable signs of clinical activity in
patients with PD-(L)1-resistant cancers from our dose expansion cohortpatients who face poor odds and few options. Beyond the responses we have observed,
whats striking is the emerging potential for prolonged benefit, with some PD-(L)1-resistant patients approaching a year on study. In a population with historically
low response rates and fleeting benefit from PD-(L)1 rechallenge, we observed response rates nearly three times higher than what would typically be expected in this setting. With dose expansion enrollment now
complete, were laser-focused on finalizing a Phase 2 strategy for solnerstotug, guided by the full dataset we plan to present later this year.
Highlights and Milestones
Solnerstotug (formerly SNS-101) is a conditionally active antibody designed to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) within the tumor
microenvironment. VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates.
Sensei is conducting a
multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of solnerstotug as both a monotherapy and in combination with Regenerons PD-1
inhibitor Libtayo® (cemiplimab) in patients with advanced solid tumors.
Recent updates include:
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In March, Sensei announced preliminary data from the dose expansion stage of its ongoing Phase 1/2 trial,
showing favorable activity in patients with PD-(L)1 resistant hot tumors. |
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Enrollment is now complete with a total of 63 patients: |
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10 MSS CRC patients in the monotherapy arm |
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53 patients in the cemiplimab combination arm consisting of 10 MSS CRC patients and 43 PD-(L)1 resistant hot tumor patients. |
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Full dose expansion data from the Phase 1/2 study expected by year-end
2025. |
A replay of the March 2025 webcast related to these preliminary results, featuring study investigator Dr. Shiraj Sen, is
available on the Sensei website.