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 that patient dosing has commenced in the Phase 1 clinical
trial of SENTI-202 for the treatment of relapsed/refractory
hematologic malignancies including acute myeloid leukemia (“AML”).
AML is a cancer of the blood and bone marrow and is the most common
type of acute leukemia in adults. SENTI-202, a potential
first-in-class Logic Gated off-the-shelf chimeric antigen receptor
natural killer (“CAR-NK”) investigational cell therapy, is designed
to selectively target and eliminate CD33 and/or FLT3 expressing
hematologic malignancies, including AML, while sparing healthy bone
marrow cells. Initial efficacy data is anticipated by year-end 2024
and initial durability data following in 2025.
“Launching the Phase 1 clinical trial of SENTI-202 marks an
important step forward in our mission to redefine the standard of
care for patients with AML, offering hope where options are scarce
and outcomes are dire. By systematically engineering SENTI-202 to
address the complexities of AML heterogeneity while safeguarding
healthy marrow cells, we aim to address the critical limitations of
existing therapies,” said Kanya Rajangam, MD, PhD, Head of Research
& Development and Chief Medical Officer of Senti Bio. “This
milestone underscores our unwavering commitment to advancing our
clinical program for the betterment of patients, and we eagerly
anticipate the potential impact SENTI-202 may have in transforming
the lives of people with cancer.”
The Phase 1 clinical trial of SENTI-202 (NCT06325748) is
enrolling adult patients with relapsed or refractory (“r/r”) CD33
and/or FLT3 expressing hematologic malignancies, including AML, at
multiple sites in the United States and Australia. The dose finding
trial is evaluating two dose levels, either 1 or 1.5 billion
SENTI-202 cells, administered in cycles, each comprising of three
once-per-week doses, after disease specific lymphodepleting
conditioning. Patients may continue to receive multiple cycles of
treatment based on safety and efficacy data.
Through Senti Bio’s previously announced agreement with GeneFab,
the Company has prepaid the majority of manufacturing-related
expenses through the completion of the Phase 1 trial.
About SENTI-202SENTI-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 heme 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 Biosciences 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. The
Company’s wholly-owned pipeline utilizes off-the-shelf chimeric
antigen receptor natural killer (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.
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
its growth, strategy, progress and timing of its clinical trials
for SENTI-202, including data announcements; 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, and (ix) 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 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 Twitter (@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 Twitter and LinkedIn. The information that we post on our
website or on Twitter 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.
Senti Bio Contacts Investors:
investors@sentibio.com Media: media@sentibio.com
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