Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the
“Company”), a clinical-stage biotechnology company developing
next-generation cell and gene therapies using its proprietary Gene
Circuit platform, today reported the receipt of an additional $1.0
million from the California Institute of Regenerative Medicine
(CIRM) upon the achievement of clinical study enrollment
milestones. As previously announced, the CIRM awarded an $8 million
grant to Senti Bio to support the ongoing clinical development of
SENTI-202, a potential first-in-class Logic Gated off-the-shelf
chimeric antigen receptor natural killer (CAR-NK) investigational
cell therapy, for the treatment of relapsed/refractory hematologic
malignancies including acute myeloid leukemia (AML). To date, the
Company has received a total of $7.4 million of the $8.0 million
available under the grant.
“We are grateful for the continued support of
the CIRM as we continue to rapidly enroll into our SENTI-202
clinical trial. We are committed to advancing this important
program forward and based on the recently presented positive
preliminary results, we are becoming more confident in its
potential to provide a much-needed treatment option for patients,”
commented Timothy Lu, MD, PhD, Co-Founder and CEO of Senti
Biosciences.
SENTI-202 is the Company’s first-in-class
off-the-shelf Logic Gated CD33 OR FLT3 NOT EMCN CAR NK cell therapy
product candidate designed to selectively target and eliminate CD33
and/or FLT3-expressing hematologic malignancies, such as AML and
myelodysplastic syndrome (MDS), while sparing healthy bone marrow
cells. SENTI-202 is currently being evaluated in a Phase 1 clinical
trial (NCT06325748).
Positive preliminary results from the ongoing
Phase 1 trial as well as correlative data from patients and
preclinical data supporting Logic Gate mechanism of action were
recently presented at the American Association for Cancer Research
(AACR) Annual Meeting 2025. The data showed that SENTI-202 was
well-tolerated in the patients whose data was presented with no
dose limiting toxicities and a maximum tolerated dose was not
reached. The preliminary recommended Phase 2 dose (RP2D) was
identified based on the totality of clinical data, including
efficacy, as 1.5 x 109 CAR NK cells administered on Days 0,7,14 in
28-day Cycles following lymphodepleting chemotherapy. Two of three
patients in the preliminary RP2D cohort achieved a composite
Complete Remission (cCR); 5 of the 7 best overall response
evaluable patients across all dose levels achieved an ORR (cCR +
morphologic leukemia-free state) outcome and 4 of the 7 achieved
cCR (3 CR with full hematologic recovery, and 1 CRh (CR with
partial hematologic recovery)). Four of four cCR patients were MRD-
(Measurable Residual Disease Negative) as assessed by local
standard of care, with longest cCR duration of 8+ months
ongoing.
About Senti BioSenti Bio is a
biotechnology company developing a new generation of cell and gene
therapies for patients living with incurable diseases. To achieve
this, Senti Bio is leveraging its synthetic biology platform to
engineer Gene Circuits into new medicines with enhanced precision
and control. These Gene Circuits are designed to precisely kill
cancer cells, to spare healthy cells, to increase specificity to
target tissues, and/or to be controllable even after
administration. The Company’s wholly-owned pipeline is comprised of
cell therapies engineered with Gene Circuits to target challenging
liquid and solid tumor indications. Senti’s Gene Circuits have been
shown preclinically to work in both NK and T cells. Senti Bio has
also preclinically demonstrated the potential breadth of Gene
Circuits in other modalities and diseases outside of oncology, and
continues to advance these capabilities through partnerships.
Forward-Looking Statements
This press release and document contain certain
statements that are not historical facts and are considered
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. These forward-looking
statements generally are identified by the words “believe,”
“could,” “predict,” “continue,” “ongoing,” “project,” “expect,”
“anticipate,” “estimate,” “intend,” “strategy,” “future,”
“opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,”
“will continue,” “will likely result,” “forecast,” “seek,” “target”
and similar expressions that predict or indicate future events or
trends or that are not statements of historical matters.
Forward-looking statements are predictions, projections, and other
statements about future events that are based on current
expectations of Senti Bio’s management and assumptions, whether or
not identified in this document, and, as a result, are subject to
risks and uncertainties. Forward-looking statements include, but
are not limited to, expectations regarding Senti Bio’s progress
future results from its clinical trials for SENTI-202; and the
ability of any product candidate to perform in humans in a manner
consistent with nonclinical, preclinical or previous clinical study
data. These forward-looking statements are provided for
illustrative purposes only and are not intended to serve as and
must not be relied on by any investor as, a guarantee, an
assurance, a prediction, or a definitive statement of fact or
probability. Actual events and circumstances are difficult or
impossible to predict and will differ from assumptions. Many actual
events and circumstances are beyond the control of Senti Bio. Many
factors could cause actual future results to differ materially from
the forward-looking statements in this document, including but not
limited to: (i) changes in domestic and foreign business, market,
financial, political and legal conditions, (ii) changes in the
competitive and highly regulated industries in which Senti Bio
operates, variations in operating performance across competitors,
changes in laws and regulations affecting Senti Bio’s business,
(iii) the ability to implement business plans, forecasts and other
expectations, (iv) the risk of downturns and a changing regulatory
landscape in Senti Bio’s highly competitive industry, (v) risks
relating to the uncertainty of any projected financial information
with respect to Senti Bio, (vi) risks related to uncertainty in the
timing or results of Senti Bio’s clinical trial start up, clinical
studies, patient enrollment, and GMP manufacturing startup
activities, (vii) Senti Bio’s dependence on third parties in
connection with clinical trial startup, clinical studies, and GMP
manufacturing activities, (viii) risks related to delays and other
impacts from macroeconomic and geopolitical events, increasing
rates of inflation and rising interest rates on business
operations, (ix) risks related to the timing and utilization of the
grant from CIRM, and (x) the success of any future research and
development efforts by Senti Bio. The foregoing list of factors is
not exhaustive. You should carefully consider the foregoing factors
and the other risks and uncertainties described in the “Risk
Factors” section of Senti Bio’s most recent periodic report filed
with the U.S. Securities and Exchange Commission (“SEC”), and other
documents filed by Senti Bio from time to time with the SEC. These
filings identify and address other important risks and
uncertainties that could cause actual events and results to differ
materially from those contained in the forward-looking statements
in this document. There may be additional risks that Senti Bio does
not presently know, or that Senti Bio currently believes are
immaterial that could also cause actual results to differ from
those contained in the forward-looking statements in this document.
Forward-looking statements speak only as of the date they are made.
Senti Bio anticipates that subsequent events and developments may
cause Senti Bio’s assessments to change. Except as required by law,
Senti Bio assumes no obligation to update publicly any
forward-looking statements, whether as a result of new information,
future events, or otherwise.Availability of Other
Information About Senti Biosciences, Inc.For more
information, please visit the Senti Bio website at www.sentibio.com
or follow Senti Bio on X (@SentiBio) and LinkedIn (Senti
Biosciences). Investors and others should note that we communicate
with our investors and the public using our company website
(www.sentibio.com), including, but not limited to, company
disclosures, investor presentations and FAQs, Securities and
Exchange Commission filings, press releases, public conference call
transcripts and webcast transcripts, as well as on X and LinkedIn.
The information that we post on our website or on X or LinkedIn
could be deemed to be material information. As a result, we
encourage investors, the media and others interested to review the
information that we post there on a regular basis. The contents of
our website or social media shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933, as
amended.
Investor Contact:JTC Team, LLCJenene
Thomas(908) 824-0775SNTI@jtcir.com
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