Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company, has shared significant updates regarding its lead program, solnerstotug (SNS-101), and outlined key upcoming milestones. The company anticipates the dose expansion arm of solnerstotug to be fully enrolled by the end of Q1 2025, with a clinical data update expected in Q2 2025.
John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics, reflected on the progress made in 2024, stating that solnerstotug has shown potential to overcome safety and pharmacological challenges associated with first-generation antibodies targeting the immune checkpoint VISTA. The program has demonstrated promising early signs of activity, even in a predominantly 'cold' tumor patient population unlikely to respond to immunotherapy.
Looking forward to 2025, Sensei aims to share significant efficacy data at optimal doses, focusing on a 'hot' tumor patient population more likely to respond to immunotherapy but with primary or acquired resistance to PD-1 inhibitors. With financial resources extending into the second quarter of 2026, Sensei is well-positioned to advance solnerstotug through the completion of the Phase 1 portion of its study.
Highlights and Milestones for Solnerstotug (SNS-101):
- Solnerstotug is a conditionally active antibody designed to selectively target the immune checkpoint VISTA within the tumor microenvironment.
- A multi-center Phase 1/2 clinical trial is underway to evaluate solnerstotug's safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy, both as a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) in patients with advanced solid tumors.
- As of January 1, 2025, 45 patients have been enrolled in the dose expansion portion of the trial, with enrollment expected to reach approximately 60 patients by the end of Q1 2025.
- Data from evaluable patients is expected to be reported in Q2 2025, alongside patient follow-up data from the dose escalation cohorts.
- Solnerstotug continues to be well tolerated, with efforts ongoing to explore biomarker correlates of clinical benefit.
Sensei Biotherapeutics is dedicated to the discovery and development of next-generation therapeutics for cancer patients, leveraging its TMAb™ platform to develop conditionally active therapeutics designed to selectively target the tumor microenvironment. For more information, visit www.senseibio.com.
