Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a
biotechnology company developing next-generation cell and gene
therapies using its proprietary Gene Circuit platform, today
announced the commencement of a grant award of $8 million from the
California Institute for Regenerative Medicines (“CIRM”). Pursuant
to the executed agreement with CIRM, the first tranche of the grant
award is expected to be received in August 2024.
The CIRM grant will 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 (“r/r”)
hematologic malignancies including acute myeloid leukemia (“AML”).
The Phase 1 clinical trial of SENTI-202 (NCT06325748) is currently
enrolling adult patients with r/r CD33 and/or FLT3 expressing
hematologic malignancies, including AML, at multiple sites in the
United States and Australia. Initial efficacy data are anticipated
by year-end 2024 with initial durability data following in
2025.
About SENTI-202
SENTI-202 is a Logic Gated off-the-shelf 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 has three main components. First, the OR GATE,
which is an activating CAR that targets CD33 and FLT3. By targeting
either or both of these antigens, SENTI-202 could effectively kill
both the leukemic blasts and leukemic stem cells that form an
important basis for AML disease. Second, the NOT GATE, which is
designed to recognize the healthy cells and protect those healthy
cells from being killed. Third, the calibrated-release IL-15
technology, which is designed to significantly increase cell
persistence, expansion and activity of both the CAR- NK cells and
the host immune cells. The NK cells used to construct SENTI-202 are
sourced from healthy adult donors, which have been screened based
on a set of criteria that reflect manufacturability and product
quality, and are then cryopreserved prior to use in manufacturing
to minimize variability. Senti Bio is currently enrolling adult
patients with r/r CD33 and/or FLT3 expressing hematologic
malignancies in a Phase 1 clinical trial for SENTI-202, which can
be a potential first-in-class allogenic treatment for AML/MDS
patients.
Senti Bio has published SENTI-202 preclinical data
demonstrating the potential of Logic Gated CAR-NK cell therapy for
the treatment of AML.
About Acute Myeloid LeukemiaAcute myeloid
leukemia is a cancer of the blood and bone marrow and is the most
common type of acute leukemia in adults. It is estimated there will
be 20,800 new cases of AML in the United States in 2024. The
five-year survival rate for these patients is approximately 30%.
AML is currently treated with chemotherapy, targeted therapies,
and/or allogeneic or autologous stem cell transplant. For patients
with relapsed or refractory AML, there are few treatment options
and median overall survival is typically less than seven
months.
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 a synthetic biology platform called Gene Circuits to
create therapies with enhanced precision and control. These Gene
Circuits are designed to precisely kill cancer cells, spare healthy
cells, increase specificity to target cells and control the
expression of drugs even after administration. Senti Bio’s
wholly-owned pipeline utilizes off-the-shelf CAR-NK cells,
outfitted with Gene Circuits, to target challenging liquid and
solid tumor indications. Senti Bio has also preclinically
demonstrated the potential breadth Gene Circuits in other
modalities, diseases outside of oncology, and continues to advance
these capabilities through partnerships with Spark Therapeutics and
BlueRock Therapeutics.
About CIRMCIRM was created by the people of
California to accelerate stem cell treatments to patients with
unmet medical needs, and act with a sense of urgency to succeed in
that mission. To meet this challenge, CIRM, with its team of highly
trained and experienced professionals, actively partners with both
academia and industry in a hands-on, entrepreneurial environment to
fast track the development of today’s most promising stem cell
technologies.
With $5.5 billion in funding and more than 150 active stem cell
programs in its portfolio, CIRM is one of the world’s largest
institutions dedicated to helping people by bringing the future of
cellular medicine closer to reality.
Forward-Looking StatementsThis 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 growth, strategy, progress and timing of its clinical
trials for SENTI-202, including the timing and the amount of the
grant from CIRM; the timing of availability of data from the
ongoing Phase 1 clinical trial of SENTI-202; the ability of any
product candidate to perform in humans in a manner consistent with
nonclinical, preclinical or previous clinical study data; and
expectations regarding its growth, strategy, progress and timing of
its clinical trials, including the anticipated dosing of patients
and availability of data, and the timing thereof. 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 Quarterly Report on Form 10-Q, filed with the U.S. Securities
and Exchange Commission (“SEC”) on May 9, 2024, and other documents
filed by Senti Bio from time to time with the 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 https://www.sentibio.com or follow Senti Bio
on X (formerly Twitter) (@SentiBio) and LinkedIn (Senti
Biosciences). Investors and others should note that Senti Bio
communicates with its investors and the public using its company
website (www.sentibio.com), including, but not limited to, company
disclosures, investor presentations and FAQs, SEC filings, press
releases, public conference call transcripts and webcast
transcripts, as well as on X (formerly Twitter) and LinkedIn. The
information that Senti Bio posts on its website or on X (formerly
Twitter) or LinkedIn could be deemed to be material information. As
a result, Senti Bio encourages investors, the media and others
interested to review the information that it posts there on a
regular basis. The contents of Senti Bio’s website or social media
shall not be deemed incorporated by reference in any filing under
the Securities Act of 1933, as amended.
Senti Bio
ContactInvestors: investors@sentibio.comMedia: media@sentibio.com
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