Fate Therapeutics Announces Initiation of Phase 1 Clinical Trial for FT825 / ONO-8250 in Patients with HER2-expressing Advanced Solid Tumors
08 1월 2024 - 10:00PM
Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage
biopharmaceutical company dedicated to bringing a first-in-class
pipeline of induced pluripotent stem cell (iPSC)-derived cellular
immunotherapies to patients with cancer and autoimmune disorders,
today announced the initiation of enrollment for its Phase 1
clinical trial of FT825 / ONO-8250, a multiplexed-engineered,
chimeric antigen receptor (CAR) T-cell product candidate targeting
human epidermal growth factor receptor 2 (HER2). The iPSC-derived
CAR T-cell product candidate incorporates a novel HER2-targeted
antigen binding domain and is designed to overcome unique
challenges in treating solid tumors. The Phase 1 study of FT825 /
ONO-8250 is being conducted under a strategic collaboration with
Ono Pharmaceutical Co., Ltd. (Ono).
“Since the formation of our partnership with Ono in
2018, we have worked closely together to pioneer the manufacture of
CD8 alpha-beta T cells from iPSCs and to discover and integrate
novel synthetic controls of cell function into our iPSC-derived CAR
T-cell product platform for safe and effective treatment of solid
tumors, including functional elements designed to promote cell
trafficking, resist immune suppression in the tumor
microenvironment, and preferentially target cancer cells,” said
Scott Wolchko, President and Chief Executive Officer of Fate
Therapeutics. “The preclinical data for FT825 / ONO-8250 indicate a
highly-differentiated therapeutic profile across a broad range of
solid tumors, with the novel HER2-targeted antigen binding domain
demonstrating selective targeting of cancer cells expressing HER2
including those with low expression. We are excited to initiate the
Phase 1 study in collaboration with Ono and assess the potential to
benefit patients with hard-to-treat advanced solid tumors who
currently have limited treatment options.”
Designed using the Company’s iPSC Product Platform,
FT825 / ONO-8250 incorporates seven novel synthetic controls of
cell function including a CXCR2 receptor to promote cell
trafficking, a chimeric TGFβ receptor to redirect immunosuppressive
signals in the tumor microenvironment, and a high-affinity,
non-cleavable CD16a receptor to enable antibody-dependent cellular
cytotoxicity. Preclinical data of FT825 / ONO-8250 presented at the
2023 Society for Immunotherapy of Cancer Annual Meeting
demonstrated that the profile of the novel HER2-targeted antigen
binding domain is unique and differentiated from that of
trastuzumab, exhibiting similar potency with greater specificity
for cancer cells expressing HER2.
The Phase 1 study is designed to investigate a
single dose of FT825 / ONO-8250 as monotherapy and in combination
with monoclonal antibody therapy in previously-treated patients
with advanced solid tumors. The dose escalation and dose expansion
portions of the trial are expected to evaluate safety,
tolerability, and pharmacokinetics as well as anti-tumor activity
by overall response rate, duration of response and disease control
rate.
Under the terms of its Collaboration and Option
Agreement with Ono, Fate will jointly develop and commercialize
FT825 / ONO-8250 with Ono in the U.S. and Europe, and Ono maintains
exclusive development and commercialization rights for FT825 /
ONO-8250 in the rest of the world. Fate is eligible to receive
clinical, regulatory and commercial milestone payments as well as
tiered royalties on net sales outside of the United States and
Europe by Ono. The parties are currently conducting preclinical
development of an additional solid tumor program targeting an
undisclosed tumor-associated antigen.
About Fate Therapeutics’ iPSC Product
PlatformThe Company’s proprietary induced pluripotent stem
cell (iPSC) product platform enables mass production of
off-the-shelf, multiplexed-engineered cell products that are
selectively designed, incorporate novel synthetic controls of cell
function, and are intended to deliver multiple mechanisms of
therapeutic importance to patients. Human iPSCs possess the unique
dual properties of unlimited self-renewal and differentiation
potential into all cell types of the body. The Company’s platform
combines multiplexed engineering and single-cell selection of human
iPSCs to create clonal master iPSC lines. Analogous to master cell
lines used to mass produce biopharmaceutical drug products such as
monoclonal antibodies, the Company utilizes its clonal master iPSC
lines as a renewable cell source to manufacture
multiplexed-engineered cell products which are well-defined and
uniform in composition, can be stored in inventory for
off-the-shelf availability, can be combined and administered with
other therapies, and can potentially reach a broad patient
population. As a result, the Company’s platform is uniquely
designed to overcome numerous limitations associated with the
manufacture of cell therapies using patient- or donor-sourced
cells. Fate Therapeutics’ iPSC product platform is supported by an
intellectual property portfolio of over 400 issued patents and 450
pending patent applications.
About Fate Therapeutics, Inc.Fate
Therapeutics is a clinical-stage biopharmaceutical company
dedicated to bringing a first-in-class pipeline of induced
pluripotent stem cell (iPSC)-derived cellular immunotherapies to
patients with cancer and autoimmune disorders. Using its
proprietary iPSC product platform, the Company has established a
leadership position in creating multiplexed-engineered iPSC lines
and in the manufacture and clinical development of off-the-shelf,
iPSC-derived cell products. The Company’s effector cell pipeline
includes multiplexed-engineered, iPSC-derived natural killer (NK)
cell and T-cell product candidates, which incorporate novel
synthetic controls of cell function, such as chimeric antigen
receptors (CARs) to target tumor-associated antigens, and are
intended to deliver multiple mechanisms of therapeutic importance
to patients including in combination with well-established cancer
therapies. Fate Therapeutics is headquartered in San Diego, CA. For
more information, please visit www.fatetherapeutics.com.
Forward-Looking StatementsThis
release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995 including
statements regarding the progress of and plans related to the
Company's product candidates, clinical studies and preclinical
research and development programs, the therapeutic and market
potential of the Company’s research and development programs and
product candidates, the Company’s clinical and product development
strategy, and the Company’s expectations regarding progress and
timelines, and the objectives, plans and goals of its collaboration
with Ono. These and any other forward-looking statements in this
release are based on management's current expectations of future
events and are subject to a number of risks and uncertainties that
could cause actual results to differ materially and adversely from
those set forth in or implied by such forward-looking statements.
These risks and uncertainties include, but are not limited to, the
risk that the Company’s research and development programs and
product candidates may not demonstrate the requisite safety,
efficacy, or other attributes to warrant further development or to
achieve regulatory approval, the risk that results observed in
prior studies of the Company’s product candidates, including
preclinical studies and clinical trials, will not be observed in
ongoing or future studies involving these product candidates, the
risk of a delay or difficulties in the manufacturing of the
Company’s product candidates or in the initiation and conduct of,
or enrollment of patients in, any clinical trials, the risk that
the Company may cease or delay preclinical or clinical development
of any of its product candidates for a variety of reasons
(including requirements that may be imposed by regulatory
authorities on the initiation or conduct of clinical trials,
changes in the therapeutic, regulatory, or competitive landscape
for which the Company’s product candidates are being developed, the
amount and type of data to be generated or otherwise to support
regulatory approval, difficulties or delays in patient enrollment
and continuation in the Company’s ongoing and planned clinical
trials, difficulties in manufacturing or supplying the Company’s
product candidates for clinical testing, and any adverse events or
other negative results that may be observed during preclinical or
clinical development), the risk that its product candidates may not
produce therapeutic benefits or may cause other unanticipated
adverse effects, the risk that the Company may not comply with its
obligations under and otherwise maintain its collaboration
agreement with Ono or other parties with which the Company may
enter into future collaborations on the agreed upon terms, the risk
that research funding and milestone payments received by the
Company under its collaboration may be less than expected, and the
risk that the Company may incur operating expenses in amounts
greater than anticipated. For a discussion of other risks and
uncertainties, and other important factors, any of which could
cause the Company’s actual results to differ from those contained
in the forward-looking statements, see the risks and uncertainties
detailed in the Company’s periodic filings with the Securities and
Exchange Commission, including but not limited to the Company’s
most recently filed periodic report, and from time to time in the
Company’s press releases and other investor communications. Fate
Therapeutics is providing the information in this release as of
this date and does not undertake any obligation to update any
forward-looking statements contained in this release as a result of
new information, future events or otherwise.
Contact:Christina TartagliaStern
Investor Relations,
Inc.212.362.1200christina.tartaglia@sternir.com
Fate Therapeutics (NASDAQ:FATE)
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부터 4월(4) 2024 으로 5월(5) 2024
Fate Therapeutics (NASDAQ:FATE)
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부터 5월(5) 2023 으로 5월(5) 2024