On January 8, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported corporate updates on its lead program, solnerstotug (SNS-101) and upcoming milestones (Press release, Sensei Biotherapeutics, JAN 8, 2025, View Source [SID1234649512]).
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"2024 was a noteworthy year for Sensei and our pioneering lead program, solnerstotug. We demonstrated that solnerstotug can overcome the safety and pharmacological hurdles associated with first-generation antibodies targeting the immune checkpoint VISTA, positioning it as the first program in its class with potential to demonstrate clinically meaningful antitumor responses. Moreover, despite enrolling a predominantly ‘cold’ tumor patient population that was unlikely to respond to immunotherapy, solnerstotug demonstrated promising early signs of activity," said John Celebi, President and Chief Executive Officer. "Looking ahead, 2025 is set to be a pivotal year as we seek to share our first significant efficacy data at optimal doses that include a ‘hot’ tumor patient population more likely to respond to immunotherapy that nonetheless has primary or acquired resistance to PD-1 inhibitors. With cash runway into the second quarter of 2026, we are positioned to advance solnerstotug through the completion of the Phase 1 portion of this study."
Highlights and Milestones
Solnerstotug (SNS-101)
Solnerstotug 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 (SNS-101) as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors. Key findings and updates as of January 1, 2025 include:
A total of 45 patients have been enrolled in the dose expansion portion of the Phase 1/2 clinical trial.
The majority of the "hot" tumor patients enrolled in the combination dose expansion to date have progressed on a prior anti-PD-1 therapy or are PD-L1 negative, making it highly unlikely that these patients would respond upon re-challenge with anti-PD-1 alone.
Sensei expects to complete enrollment of the dose expansion with approximately 60 patients by the end of Q1 2025.
The Company expects to report data from evaluable patients in Q2 2025. Patient follow-up data from the dose escalation cohorts will also be presented.
Solnerstotug continues to be well tolerated with a best-in-class pharmacokinetic profile.
Dose optimization is now focused on dose levels of 3 and 15 mg/kg Q3W to support the Phase 2 doses in several patient populations under consideration.
Efforts are ongoing to explore biomarker correlates of clinical benefit using peripheral immunophenotyping and tumor genomic and transcriptomic analyses.