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 a new strategic collaboration with Celest Therapeutics
(Shanghai) Co. Ltd (“Celest”), a China-based biotechnology company,
for the clinical development of SENTI-301A to treat solid tumors in
China.
Through this collaboration, Celest will lead
clinical development, operations, and manufacturing for the
advancement of SENTI-301A with technical support from Senti Bio.
Celest plans to enroll patients initially through a pilot trial in
mainland China and expects to enroll the first patient in the first
half of 2024. Celest and Senti Bio have the option to expand
clinical development of SENTI-301A to Hong Kong, Macau and Taiwan.
Senti Bio will retain all commercialization rights outside of
mainland China, Hong Kong, Macau, and Taiwan for SENTI-301A.
Under the terms of the collaboration, Senti Bio
will be eligible to receive up to $156 million in certain milestone
payments, in addition to potential tiered royalty payments. Other
terms of the transaction were not disclosed.
The planned dose finding trial will include 9
patients with advanced glypican 3 (“GPC3”)-expressing
hepatocellular carcinoma (“HCC”) across two dose cohorts. Endpoints
will include safety assessments for adverse events and dose
limiting toxicities, as well as efficacy analyses using standard
response criteria for liver cancer.
“We are pleased to have established a strategic
partnership with Celest to advance the clinical development of
SENTI-301A, an objective we set earlier this year,” said Timothy
Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio.
“By leveraging Celest’s strength to accelerate clinical
development, manufacturing, and regulatory activities in China, we
are one step closer to bringing Senti’s Gene Circuit technology to
patients who have limited therapeutic options. We look forward to
collaborating with the experienced team at Celest, a company
committed to the clinical development of innovative drugs in
China.”
“Our partnership with Senti Bio provides
multiple synergies in our mission to develop next-generation cell
therapies in China to fulfill the tremendous unmet medical need in
combating cancer,” said Erdong Hua, Chairman at Celest
Therapeutics. “We are excited to combine Senti’s novel Gene Circuit
technology with Celest’s clinical expertise to drive SENTI-301A
into the clinic and begin treating patients.”
The Company has previously highlighted the
significant prevalence of HCC and market opportunities for HCC
treatments in Asia. HCC remains the predominant histological type
of primary liver cancer in Asia.
SENTI-301A is a multi-armed off-the-shelf
healthy donor derived CAR-NK cell therapy designed for the
treatment of GPC3 expressing tumors. The engineered NK cells target
the GPC3 antigen, which is highly expressed in 70% to 90% of HCCs
and has low or no expression on normal adult tissues. Additionally,
SENTI-301A incorporates the calibrated release interleukin-15
(crIL-15), a multi-functional immuno-stimulatory payload designed
to simultaneously stimulate surrounding immune cells and promote
CAR-NK cell expansion, persistence and tumor killing. Senti Bio has
shown comprehensive preclinical data demonstrating robust in vitro
and in vivo killing of relevant tumor cells with SENTI-301A.
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. Senti Bio’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.
About Celest TherapeuticsCelest
Therapeutics LLC was founded to develop intelligent CAR-immune cell
therapy for effective treatment of challenging solid tumors. Celest
technology platforms employ a suite of immunological technologies,
including screens for tumor microenvironment (TME) induced immune
cell enrichment, trafficking and persistence. In parallel, the
platforms also identify and optimize chimeric antigen receptor
natural killer (CAR-NK) cell signaling domains using
high-throughput methods including pooled library screenings.
Incubated by 6 Dimensions Capital and 120 Capital with operational
headquarters in Shanghai, China, Celest is building next-generation
innovative cell therapy products with full-fledged capabilities
from early R&D, cell manufacturing to clinical development and
commercialization.
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, including, but not limited to, statements regarding Senti
Bio’s future expectations, plans and prospects, including without
limitation, Senti Bio’s expectations regarding the potential of
SENTI-301A and Senti Bio’s collaboration with Celest, including the
payments that Senti Bio is eligible to receive thereunder. 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, Senti Bio’s ability to continue to advance its
pipeline of preclinical programs and product candidates, statements
regarding Senti Bio’s research and development activities, the
release of additional preclinical data, as well as statements about
the potential attributes and benefits of Senti Bio’s product
candidates and platform technology. 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 preclinical studies, IND filings, and GMP
manufacturing startup activities, (vii) Senti Bio’s dependence on
third parties, including Celest, in connection with preclinical and
IND-enabling studies, IND and other regulatory filings, and GMP
manufacturing buildout and startup activities, (viii) risks related
to delays and other impacts from the COVID-19 pandemic, and (ix)
the success of any future research and development efforts by Senti
Bio or its collaboration partners, including Celest. 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 August 11, 2023, 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 ContactInvestors:
investors@sentibio.com Media: media@sentibio.com
Celest Therapeutics
ContactInfo@celesttx.com
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