• New data from multi-dose GLP toxicology study of SNS-101 in cynomolgus monkeys further support exceptional PK and safety profile 
  
• Mechanistic mouse data show SNS-101 drives tumor macrophages to adopt an immunostimulatory, anti-tumor phenotype 

BOSTON, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today will present new preclinical data from SNS-101, a clinical-stage conditionally active, human monoclonal antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation), at the Seventh Annual CRI-ENCI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival, held on September 20 – 23, 2023 in Milan, Italy.

“We believe these data further support the potential best-in-class PK and safety profile of SNS-101 and its ability to effectively target VISTA, a promising, but difficult-to-drug immune checkpoint,” said Edward van der Horst, Ph.D., Chief Scientific Officer of Sensei Biotherapeutics. “Restricting drug activity to low pH conditions, such as those found in the acidic tumor microenvironment, allowed us to safely dose SNS-101 in our multi-dose NHP study at increasing levels while maintaining linear elimination kinetics and displaying no target-mediated drug disposition or adverse effects. Paired with new mechanistic data showing SNS-101 can shift immunosuppressive macrophages towards an anti-tumor phenotype, we believe SNS-101 could provide a transformative treatment option for patients. We look forward to sharing data from our ongoing clinical trial later this year.”

Presentation Highlights:

• SNS-101 displayed linear elimination kinetics and no target-mediated drug disposition or adverse effects in a multi-dose GLP toxicology study in cynomolgus monkeys evaluating SNS-101 doses of 1, 10 and 100 mg/kg.
• In MC38 tumor-bearing mice, SNS-101 alone and in combination with an anti-PD-1 antibody shifted the cytokine expression profile of immunosuppressive myeloid cells in the tumor microenvironment to an anti-tumor, M1 phenotype. The expression of anti-tumor cytokines was correlated with a reduction in tumor size.

Sensei is evaluating SNS-101 in a Phase 1/2 clinical trial in patients with advanced solid tumors, and expects to report initial monotherapy pharmacokinetic and safety data by year-end 2023. Topline monotherapy and initial combination data are anticipated in 2024.

The full poster is available for viewing on Sensei’s website and will be on display at the conference during Poster Session A, being held today, September 21, 2023, from 12:30 pm to 2:00 pm CET.

About Sensei Biotherapeutics:
Sensei Biotherapeutics (Nasdaq: SNSE) is a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients. Through its TMAb™ (Tumor Microenvironment Activated biologics) platform, Sensei develops conditionally active therapeutics designed to disable immunosuppressive signals or activate immunostimulatory signals selectively in the tumor microenvironment to unleash T cells against tumors. Sensei’s lead investigational candidate is SNS-101, a conditionally active antibody designed to block the V-domain Ig suppressor of T cell activation (VISTA) checkpoint selectively within the low pH tumor microenvironment, where VISTA acts as a suppressor of T cells by binding the receptor PSGL-1. The company is also developing SNS-102, a conditional binding monoclonal antibody targeting V-Set and Immunoglobulin Domain Containing 4 (VSIG-4), as well as SNS-103, also a conditionally active monoclonal antibody targeting ecto-nucleoside triphosphate diphosphohydrolase-1 (ENTPDase1), also known as CD39. For more information, please visit www.senseibio.com, and follow the company on Twitter @SenseiBio and LinkedIn. 

Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe”, “designed to,” “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Sensei’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of Sensei’s product candidates, as well as the timing of Sensei’s Phase 1/2 clinical trial of SNS-101, including reporting of data therefrom. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Sensei’s product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Sensei’s product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Sensei’s product candidates; the risk that Sensei’s product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that we anticipate; risks associated with Sensei’s dependence on third-party suppliers and manufacturers, including sole source suppliers, over which we may not always have full control; risks regarding the accuracy of our estimates of expenses, capital requirements and needs for additional financing; and other risks and uncertainties that are described in Sensei’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on or about August 3, 2023 and Sensei’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Michael Biega
Senior Director, Investor Relations
Sensei Biotherapeutics
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Media Contact:
Chris Railey
Ten Bridge Communications
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