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Sensei Biotherapeutics Signs Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to Expand Development Plan for SNS-101, a Conditionally Active VISTA-blocking Antibody BOSTON

Key Takeaway: Sensei Biotherapeutics has signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to broaden the research and development plan for SNS-101, a VISTA-blocking antibody. This collaboration seeks to enhance understanding of VISTA's role in immune checkpoint resistance and explore SNS-101's combination therapy potential. An Investigational New Drug (IND) application is expected to be submitted by April 2023, with trials projected to start later in the year, pending regulatory approval. The agreement aims to bolster Sensei’s clinical development strategy for SNS-101.

Market Sentiment Analysis

POSITIVE FACTORS

  • Sensei Biotherapeutics enters CRADA with NCI to expand SNS-101 development.
  • Collaboration aims to improve efficacy and safety profile of SNS-101.
  • Potential for SNS-101 to be used in combination therapies beyond PD-1 inhibition.
  • Timely IND application submission expected for SNS-101.

CONCERNS & RISKS

  • Risks associated with therapy development could delay clinical trials.
  • Potential safety and efficacy profiles of SNS-101 remain uncertain.
  • Dependence on third-party suppliers poses a risk to development timelines.

Full Press Release Details

Sensei Biotherapeutics Signs Cooperative Research and Development Agreement (CRADA) with the National
Cancer Institute (NCI) to Expand Development Plan for SNS-101, a Conditionally Active VISTA-blocking Antibody
BOSTON, February 06, 2023 (GLOBE NEWSWIRE) Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and
development of next-generation therapeutics for cancer patients, today announced that it has signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH),
to expand the development of SNS-101, a conditionally active, pH-selective VISTA-blocking antibody.
Under the terms of the CRADA, Sensei will collaborate with the NCI Center for Immuno-Oncology Co-Directors, Jeffrey
Schlom, Ph.D., and James Gulley, M.D., Ph.D., and conduct preclinical studies to assess the mechanism of action of SNS-101 in combination with novel therapeutic modalities. The goal of this collaborative
effort between Sensei and the NCI is to further elucidate the role of VISTA in immune checkpoint resistance and expand the potential of SNS-101 as a combination therapy beyond anti-PD-1. Sensei expects to submit an Investigational New Drug (IND) application for SNS-101 in or before April 2023 and the trial is expected to commence thereafter
in 2023, pending regulatory clearance.
We re excited to collaborate with Dr. Schlom and Dr. Gulley, who have pioneered the use of
novel immunotherapies for a range of human cancers and are recognized for their expertise in translating preclinical findings into first-in-human studies for multiple
immunotherapy agents, said Edward van der Horst, Ph.D., Chief Scientific Officer of Sensei Biotherapeutics. We believe this collaboration has potential to increase the body of evidence that
pH-selective VISTA inhibition can achieve a potentially differentiated efficacy and safety profile, expand the rationale for combining inhibition of VISTA with mechanisms beyond
PD-1 inhibition, and help us build upon the current clinical development plan for SNS-101.
About Sensei Biotherapeutics
Sensei Biotherapeutics
(Nasdaq: SNSE) is an 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 checkpoints and other immunosuppressive 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
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 of Sensei s product candidates and platforms; the
potential safety profile of Sensei s product candidates, including SNS-101; the potential benefits of Sensei s product candidates, including SNS-101; the
timing of an IND submission for SNS-101 to the FDA; the timing of commencement of the planned clinical trial for SNS-101; and the potential benefits of Sensei s
collaboration with the National Cancer Institute. 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 studies, including the preclinical studies described
in this press release, 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 Sensei anticipates; 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 Sensei s 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 November 8, 2022 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.
Senior Director, Investor Relations
Ten Bridge Communications

Frequently Asked Questions

What is the recent agreement signed by Sensei Biotherapeutics?

Sensei Biotherapeutics signed a CRADA with the NCI to enhance SNS-101's development.

What is SNS-101 designed to do?

SNS-101 is a pH-selective antibody that blocks the VISTA checkpoint in tumors.

When does Sensei plan to submit an IND application for SNS-101?

The IND application for SNS-101 is expected to be submitted by April 2023.

Who will collaborate on SNS-101's preclinical studies?

NCI's Dr. Jeffrey Schlom and Dr. James Gulley will collaborate with Sensei.

What is the goal of the collaboration with the NCI?

The goal is to explore VISTA's role in immune checkpoint resistance and enhance therapy.

Last updated: Feb 6, 2023