Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a
clinical-stage biotechnology company developing next-generation
cell and gene therapies using its proprietary Gene Circuit
platform, today announced that the first patient has been dosed in
the pilot trial of SN301A in HCC in mainland China in collaboration
with Celest Therapeutics (Shanghai) Co. Ltd (“Celest”). SN301A
utilizes the anti-GPC3 + crIL-15 (each as defined below) SENTI-301A
Gene Circuit developed by Senti Bio and refers to the chimeric
antigen receptor natural killer (“CAR-NK”) product candidate
manufactured by Celest in China.
Through this collaboration, Celest is leading clinical
development, operations and manufacturing of SN301A with technical,
strategic and clinical input from Senti Bio. The clinical trial is
designed to evaluate safety, pharmacokinetics and preliminary
anti-tumor activity of SN301A and will include patients with
advanced glypican 3 (“GPC3”)-expressing HCC across multiple dose
cohorts. The study endpoints include safety assessments for adverse
events and dose limiting toxicities, as well as efficacy analyses
using standard response criteria for liver cancer.
“Today’s announcement is a significant demonstration of the
progress in our strategic partnership with Celest to advance the
clinical development of SENTI-301A, our solid tumor pipeline
product candidate in China,” said Timothy Lu, MD, PhD, Chief
Executive Officer and Co-Founder of Senti Bio. “We are proud of the
rapid development to date, and value how our partnership with the
Celest team is playing an important role in bringing Senti Bio’s
Gene Circuit technology to patients who have limited or no
therapeutic options today. We are excited by the recent positive
initial clinical data from our first Gene Circuit enabled cell
therapy SENTI-202 in blood cancer, and the potential to expand our
platform to treat solid tumors with high unmet clinical needs.”
“We are thrilled to share this progress in the clinical
development of SN301A. In successfully initiating this trial, we
are now seeing the potential of integrating Senti’s novel Gene
Circuit technology to our proprietary NK cell manufacturing and
clinical operations expertise,” said Erdong Hua, Chairman of Celest
and Managing Partner of 6 Dimensions Capital. “Importantly, as the
second leading cause of cancer-related death in Asia, liver cancer
remains a large health threat in China. Statistically, over 40
percent of global HCC cases are reported in China, underscoring the
significant unmet need that we hope SN301A may help address.”
Additionally, Celest and Senti Bio have the option to expand
clinical development of SN301A to Hong Kong, Macau and Taiwan.
Senti Bio will retain all development and commercialization rights
outside of mainland China, Hong Kong, Macau and Taiwan for
SENTI-301A.
About the SN301A Clinical TrialThe safety and
efficacy of SN301A is being evaluated in an investigator-initiated
open-label, single-center study (NCT06652243) in adult patients
with advanced GPC3-expressing HCC. Three dose levels of SN301A will
be administered in cycles, each comprising of 3 weekly doses (Days
0, 7, 14) during a 28-day treatment cycle following a standard
lymphodepletion conditioning regimen of fludarabine and cytarabine.
Patients may continue to receive multiple cycles of treatment based
on their safety and efficacy results.
About SENTI-301A/SN301ASENTI-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. This
program, in collaboration with Celest, is being developed in China
as SN301A. SN301A utilizes the same Gene Circuit as SENTI-301A and
refers to the CAR-NK product manufactured by Celest in China.
About Senti BioSenti Bio is a clinical-stage
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 includes off-the-shelf CAR-NK
cells, outfitted with Gene Circuits, to target challenging liquid
and solid tumor indications. Senti Bio’s lead program SENTI-202, a
Logic Gated CD33 and/or FLT3-targeting hematologic cancer
therapeutic candidate, demonstrated complete remissions in 2 of 3
patients in initial clinical data as of September 19, 2024. Senti
Bio has also preclinically demonstrated that its Gene Circuits can
function in T cells. Additionally, Senti Bio has preclinically
demonstrated the potential breadth of Gene Circuits in other cell
and gene therapy modalities, diseases outside of oncology, and
continues to advance these capabilities through partnerships with
Roche/Spark Therapeutics and Bayer/BlueRock Therapeutics.
About CelestCelest was founded to develop
intelligent CAR-immune cell therapy for effective treatment of
challenging solid tumors. Celest technology platforms employ a
suite of in-house developed immunological technologies, including
platforms to screen for tumor microenvironment (“TME”) induced
immune cell enrichment, trafficking and persistence. In parallel,
the platforms also identify and optimize CAR-NK cell signaling
domains using high-throughput methods including pooled library
screenings. Incubated by 6 Dimensions Capital and 120 Capital with
operations 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.
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 and the timing of availability of data from the ongoing
clinical trials; the ability of any product candidate to perform in
humans in a manner consistent with nonclinical, preclinical or
previous clinical study data; the growth, strategy, progress and
timing of clinical trials for SENTI-301A through Celest in China;
expectations regarding the anticipated dosing of patients and
availability of data from clinical trials, and the timing thereof;
the ability to initiate new clinical programs; as well as
statements about the potential attributes and benefits of Senti
Bio’s platform technology and the progress and continuation of its
collaborations with Celest and other collaboration and strategic
partners. 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 Celest’s and 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 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 https://www.sentibio.com or follow Senti
Bio on X (formerly 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
Celest Contact
Info@celesttx.com
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