Sensei Biotherapeutics Reports Favorable Clinical Data for SNS-101 at 2023 SITC Annual Meeting
04 November 2023 - 7:05AM
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 reported
initial data from the monotherapy dose-escalation portion of its
Phase 1/2 clinical trial for SNS-101, a conditionally active, human
monoclonal antibody targeting the immune checkpoint VISTA (V-domain
Ig suppressor of T cell activation). The data, to be presented in a
late-breaker poster presentation at the Society for Immunotherapy
of Cancer (SITC) 38th Annual Meeting, suggest a potential
best-in-class safety and pharmacokinetic profile among VISTA
blocking antibodies and the potential to overcome long-standing
pharmacological challenges encountered by first generation
approaches to blocking VISTA.
“We are pleased to report favorable clinical data
for SNS-101, a pioneering VISTA-blocking antibody that provides
validation of our conditionally active approach. The data support
that this highly innovative antibody is well tolerated across dose
levels tested to date, shows linear, dose-dependent
pharmacokinetics predicted preclinically to elicit immune-mediated
anti-tumor activity, and a cytokine profile consistent with an
absence of cytokine release syndrome,” said John Celebi, President
and Chief Executive Officer of Sensei Biotherapeutics. “Data from
this clinical study to date provides important initial evidence
that SNS-101 can provide clinically meaningful and mechanistic
differentiation from first generation anti-VISTA approaches, as
indicated by SNS-101 dose levels that are at least 10 times higher
than the first clinical study of a competitor VISTA antibody that
was prematurely halted due to cytokine release syndrome and poor
pharmacokinetics. We believe this represents a foundational
clinical achievement in the pursuit of a transformational
VISTA-blocking antibody, and we look forward to building on this
success with additional data readouts, including efficacy analysis,
expected next year.”
The multi-center Phase 1/2 clinical trial is a dose
escalation study 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 patients with advanced solid tumors.
Summary of reported data (as of the October
3, 2023 cutoff date):
- A total of 13 patients were enrolled in the study.
- In the monotherapy dose escalation arm, ten patients were
enrolled across four dosing cohorts receiving SNS-101 treatment at
0.3, 1, 3, or 10 mg/kg.
- In the combination arm, three patients were enrolled at the
first dose level of 3.0 mg/kg of SNS-101 plus 350 mg of Libtayo®
(cemiplimab).
- Safety, cytokine expression and pharmacokinetic data were
presented for seven patients from the first three monotherapy
cohorts, all of which have cleared the dose-limiting toxicity
assessment period.
- A total of 11 adverse events (including one serious adverse
event not considered related to SNS-101) was reported in five
patients, with no dose-limiting toxicities observed. Only one
adverse event (Grade 2 dermatitis acneiform) was considered related
to SNS-101.
- There were no instances of cytokine release syndrome and no
significant changes in key inflammatory cytokines over time,
consistent with preclinical studies.
- Pharmacokinetic data demonstrate dose-proportional exposure
consistent with lack of target mediated drug disposition, no
notable accumulation with repeat dosing, and linear elimination
kinetics of SNS-101, in concordance with preclinical data.
“Too many patients remain underserved by existing
immunotherapies. SNS-101 highlights the potential of targeting
VISTA through an innovative concept, thoughtful approach and a
well-executed study as Sensei has done,” said Shiraj Sen, M.D.,
Ph.D., a medical oncologist at NEXT Oncology and investigator on
the Phase 1/2 SNS-101 clinical trial. “I’m encouraged by the
patient experience so far in the SNS-101 trial, including a
potentially best-in-class safety profile and an every-three-week
dosing schedule that helps alleviate the logistical burden imposed
on patients by agents requiring more frequent administration due to
their unfavorable PK profiles.”
Sensei expects to report initial safety and
pharmacokinetic combination data in Q1 2024, with topline
monotherapy data in Q2 2024, and topline combination data in
2024.
Presentation at SITC:
Title: A phase 1/2 study of
safety, tolerability and pharmacokinetics of SNS-101, a
pH-sensitive anti-VISTA mAb, as monotherapy and in combination with
cemiplimab in patients with advanced solid
tumorsPresentation type: Poster (late breaking
abstract)Abstract Number: 1532Date and
time: Saturday, November 4, 2023, at 9 a.m. PT – 8:30 p.m.
PTLocation: Exhibit Halls A and B1 – San Diego
Convention CenterLead authors: Shiraj Sen, M.D.,
Ph.D. and F. Donelson Smith, Ph.D.
A copy of the presentation materials will be added
to the “Events & Presentations” section of the Company’s
Investor Relations website at www.senseibio.com.
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
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 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
BiegaSenior Director, Investor RelationsSensei
Biotherapeuticsmbiega@senseibio.com
Media Contact:Chris RaileyTen
Bridge Communicationschris@tenbridgecommunications.com
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