Sensei Biotherapeutics Announces IND Clearance by U.S. FDA Enabling Phase 1 Initiation for SNS-101, a Conditionally Active VISTA-Blocking Antibody
20 Aprile 2023 - 1:30PM
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 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.
“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.
About Sensei BiotherapeuticsSensei
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
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 timing
of the first patient dosing in the planned 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, including the first patient dosing of SNS-101;
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 Annual
Report on Form 10-K filed with the U.S. Securities and Exchange
Commission (SEC) on March 29, 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
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