On April 20, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SNS-101, a conditionally active VISTA-blocking antibody, paving the way for the Company to conduct a Phase 1/2 clinical trial in patients with solid tumors (Press release, Sensei Biotherapeutics, APR 20, 2023, View Source [SID1234630357]).

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"Receiving IND clearance to advance our first conditionally active antibody into a Phase 1/2 clinical trial represents an important milestone for Sensei. We believe that SNS-101 has the potential to make a significant impact in the field and to improve the lives of cancer patients worldwide," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "We are delighted to bring SNS-101 into the clinic and explore its potential as a transformative treatment option for patients with solid tumors."

The Phase 1/2 clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101 as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in solid-tumor cancer patients. The Phase 1 dose escalation portion of the clinical trial will be followed by an expansion Phase 2 in selected patient populations once a recommended Phase 2 dose is determined. SNS-101 will be administered as an intravenous infusion once every three weeks. Sensei expects to dose the first patient in mid-2023.

"Based on our preclinical data, we believe SNS-101 will be the first antibody to meaningfully explore the VISTA axis in the immuno-oncology space, with potential to achieve a higher therapeutic index and a more favorable tolerability profile than drugs limited by toxicity and poor pharmacokinetics," said Edward van der Horst, Ph.D., Chief Scientific Officer of Sensei.

SNS-101 is a conditionally active, human monoclonal IgG1 antibody designed to selectively block the VISTA checkpoint in the tumor microenvironment, which acts as a suppressor of T cells by binding the receptor PSGL-1. Preclinical studies have demonstrated SNS-101’s potential to inhibit tumor growth as monotherapy, significantly enhance the anti-tumor effects of PD-1 blockade, avoid poor pharmacokinetics from target-mediated drug disposition and lower the risk of cytokine release syndrome.