Exhibit 99.1
Sensei Biotherapeutics Reports Full Year 2024 Financial Results and Update on Clinical Progress
- Preliminary efficacy data from Phase 1/2 dose expansion cohort show durable responses and tumor shrinkage in a PD-(L)1 resistant hot tumor patient population -
- Solnerstotug continues to
demonstrate a well-tolerated safety and tolerability profile -
- Achieved target enrollment in dose expansion cohort; full data
expected by year-end 2025 -
- Cash runway into the second quarter of 2026 -
BOSTON, MA March 28, 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 full year 2024, and provided corporate updates.
2024 was a pivotal year for Sensei, as we advanced solnerstotug through dose expansion and began to demonstrate its clinical potential in patients who
have progressed on and are resistant to PD-(L)1 therapy said John Celebi, President and CEO of Sensei Bio. The responses weve observed in PD-(L)1
resistant tumors are highly encouraging and we believe support solnerstotugs differentiated approach to targeting VISTA. In the context of available data across checkpoint inhibitor regimens, solnerstotug stands out for its encouraging
response rates and favorable tolerability profile in PD-(L)1 resistant tumors, a setting with limited treatment options and no approved therapies targeting VISTA. We are now focused on completing dose
expansion for patients on study and finalizing a robust Phase 2 strategy.
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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Preliminary Activity in PD-(L)1 Resistant Hot Tumors
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In March 2025, Sensei presented preliminary dose expansion data showing, as of the data cutoff of March 17, 2025:
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Among 21 evaluable PD-(L)1 resistant hot tumor patients, the
combination of solnerstotug + cemiplimab demonstrated a 14% ORR (overall response rate), which is almost 3x higher than historical PD-(L)1 rechallenge response rates (≤5%), and a 62% DCR (disease control
rate), suggesting meaningful disease control in resistant tumors. |
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One durable complete response in a patient with Merkel Cell Carcinoma (MCC). |
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Two partial responses (PRs): one in a second MCC patient and one in a microsatellite instability-high (MSI-H) Colorectal Cancer (CRC) patient. |
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All patients with tumor shrinkage remain on treatment, suggesting potential for prolonged clinical benefit.
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