Sensei Biotherapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of SNS-101, a Conditionally Active VISTA-blocking Antibody, for the Treatment of Advanced Solid Tumors
June 01 2023 - 7:30AM
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 announced
that the first patient has been dosed in its Phase 1/2 clinical
trial evaluating SNS-101 for the treatment of advanced solid
tumors. SNS-101 is a conditionally active, human monoclonal IgG1
antibody, designed to selectively block the immune checkpoint VISTA
in the tumor microenvironment, which acts as a suppressor of T
cells by binding the receptor PSGL-1.
“Studying this novel, conditionally active antibody for treating
patients with a variety of VISTA-positive solid tumors aligns with
our research goals,” said James L. Gulley, M.D., Ph.D., Co-Director
of the Center for Immuno-Oncology at the National Cancer Institute,
part of the National Institutes of Health. NCI will be a Phase I
site for the trial. “The Center for Cancer Research's Center for
Immuno-Oncology at the NCI was recently established to explore
fundamental questions of cancer immunotherapy through rigorous
preclinical studies and translate these findings into clinical
trials. The goal is developing novel therapies for a spectrum of
cancers with high unmet medical needs.”
“This milestone is the latest in an exciting journey marked by
careful study of VISTA’s role in tumor growth and rigorous
experimentation by our research and development team,” said John
Celebi, President and Chief Executive Officer of Sensei
Biotherapeutics. “We’re excited to bring the promise of Sensei’s
approach to VISTA inhibition into the clinical setting, where we
believe SNS-101 will be the first drug candidate to effectively
test the VISTA axis. We believe clinical validation of SNS-101 and
the underlying approach would represent a tremendous advancement
for the field and provide a potentially transformative treatment
option for patients.”
The multi-center Phase 1/2 clinical trial will evaluate the
safety, tolerability, pharmacokinetics, pharmacodynamics and
efficacy of SNS-101 as both monotherapy and in combination with
Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) in patients with
advanced solid tumors. Preclinical data showing SNS-101’s safety
and tolerability profile and linear elimination kinetics support a
starting dose of 0.3 mg/kg for the Phase 1 monotherapy dose
escalation portion of the trial, substantially higher than other
anti-VISTA antibodies. Sensei intends to begin the Phase 1
combination dose escalation portion of the trial, based on emerging
clinical data from the monotherapy dose escalation. The Company
expects to report topline monotherapy data and initial combination
therapy data from Phase 1 in 2024. Once the recommended Phase 2
dose is determined in Phase 1, the Phase 2 cohort expansion portion
of the study will begin in selected patient populations. For more
information on the clinical trial, visit clinicaltrials.gov,
identifier NCT05864144.
About Sensei BiotherapeuticsSensei
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
StatementsAny 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 and efficacy
of Sensei’s product candidates, including SNS-101; and the expected
timing to report topline monotherapy data and initial combination
therapy data in the clinical trial for SNS-101. 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 of SNS-101, 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 Sensei 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 May 9, 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 BiegaSenior Director,
Investor RelationsSensei Biotherapeuticsmbiega@senseibio.com
Media Contact:Chris RaileyTen Bridge
Communicationschris@tenbridgecommunications.com
Sensei Biotherapeutics (NASDAQ:SNSE)
Historical Stock Chart
From Sep 2024 to Oct 2024
Sensei Biotherapeutics (NASDAQ:SNSE)
Historical Stock Chart
From Oct 2023 to Oct 2024