Fate Therapeutics Announces Exercise by ONO Pharmaceutical of Option to HER2-targeted CAR T-Cell Product Candidate for Solid Tumors
November 07 2022 - 8:00AM
Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage
biopharmaceutical company dedicated to the development of
programmed cellular immunotherapies for patients with cancer, today
announced that ONO Pharmaceutical Co., Ltd. (ONO) has exercised its
option to FT825/ONO-8250, a multiplexed-engineered, iPSC-derived,
chimeric antigen receptor (CAR) T-cell product candidate targeting
human epidermal growth factor receptor 2 (HER2)-expressing solid
tumors. The preclinical product candidate incorporates multiple
functional elements to enhance the activity and overcome unique
challenges in treating solid tumors with cell-based cancer
immunotherapies.
“We are encouraged by the compelling preclinical
data package generated for FT825/ONO-8250 under our collaboration,
which combines the antigen binder that ONO provides and Fate’s
industry-leading iPSC product platform to overcome the challenges
in solid cancer treatment,” said Toichi Takino, Senior Executive
Officer / Executive Director, Discovery & Research of ONO. “We
look forward to initiating clinical development of the
off-the-shelf, iPSC-derived CAR T-cell product candidate with the
aim of delivering benefit to patients with some of the most
difficult to treat cancers.”
Under the terms of the Collaboration and Option
Agreement, Fate will receive a milestone payment in connection with
ONO’s exercise of its option to FT825/ONO-8250. The parties will
jointly develop and commercialize FT825/ONO-8250 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
recently expanded their collaboration to initiate preclinical
development of an additional program targeting a second solid tumor
antigen.
“Over the past four years, we have worked
closely with ONO to discover and integrate novel functional
elements into our iPSC-derived CAR T-cell product platform that are
specifically designed to address challenges in treating solid
tumors, including cell trafficking and immune cell suppression in
the tumor microenvironment,” said Scott Wolchko, President and
Chief Executive Officer of Fate Therapeutics. “The preclinical data
indicate FT825/ONO-8250 has a highly-differentiated therapeutic
profile, including exhibiting anti-tumor activity against HER2-low
tumor cells. We are excited to initiate IND-enabling activities
under our collaboration with ONO with the goal of submitting an IND
application to FDA in 2023.”
Although CAR T-cell therapy has shown
significant efficacy in treating hematologic malignancies, its
wider application to solid tumors has been hampered by
tumor-associated antigen heterogeneity, inefficient CAR T-cell
trafficking to the tumor, and immunosuppression inherent to the
tumor microenvironment. The Company’s multiplexed-engineered,
iPSC-derived CAR T-cell product platform is designed to
specifically address these challenges and enable the safe and
effective treatment of solid tumors as monotherapy and in
combination with monoclonal antibody therapy. At the Society for
Immunotherapy of Cancer (SITC) 37th Annual Meeting to be held from
November 8-12, 2022 in Boston, the Company is presenting a poster
presentation of FT825/ONO-8250 entitled “Off-the-shelf iPSC-derived
CAR-T cells containing seven functional edits overcome antigen
heterogeneity, improve trafficking and withstand immunosuppression
associated with failed tumor treatment” (Abstract ID: 304; November
11, 2022, 9:00 AM – 9:00 PM), which highlights the incorporation of
a synthetic CXCR2 receptor to promote cell trafficking, a synthetic
TGFβ receptor to redirect immunosuppressive signals in the tumor
microenvironment, and a synthetic interleukin-7 receptor fusion
protein to induce T-cell activation into its iPSC-derived CAR
T-cell product platform.
About Fate Therapeutics’ iPSC Product
PlatformThe Company’s proprietary induced pluripotent stem
cell (iPSC) product platform enables mass production of
off-the-shelf, engineered, homogeneous cell products that are
designed to be administered with multiple doses to deliver more
effective pharmacologic activity, including in combination with
other cancer treatments. Human iPSCs possess the unique dual
properties of unlimited self-renewal and differentiation potential
into all cell types of the body. The Company’s first-of-kind
approach involves engineering human iPSCs in a one-time genetic
modification event and selecting a single engineered iPSC for
maintenance as a clonal master iPSC line. Analogous to master cell
lines used to manufacture biopharmaceutical drug products such as
monoclonal antibodies, clonal master iPSC lines are a renewable
source for manufacturing cell therapy products which are
well-defined and uniform in composition, can be mass produced at
significant scale in a cost-effective manner, and can be delivered
off-the-shelf for patient treatment. As a result, the Company’s
platform is uniquely designed to overcome numerous limitations
associated with the production of cell therapies using patient- or
donor-sourced cells, which is logistically complex and expensive
and is subject to batch-to-batch and cell-to-cell variability that
can affect clinical safety and efficacy. Fate Therapeutics’ iPSC
product platform is supported by an intellectual property portfolio
of over 350 issued patents and 150 pending patent applications.
About Fate Therapeutics, Inc.Fate
Therapeutics is a clinical-stage biopharmaceutical company
dedicated to the development of first-in-class cellular
immunotherapies for patients with cancer. The Company has
established a leadership position in the clinical development and
manufacture of universal, off-the-shelf cell products using its
proprietary induced pluripotent stem cell (iPSC) product platform.
The Company’s immuno-oncology pipeline includes off-the-shelf,
iPSC-derived natural killer (NK) cell and T-cell product
candidates, which are designed to synergize with well-established
cancer therapies, including immune checkpoint inhibitors and
monoclonal antibodies, and to target tumor-associated antigens
using chimeric antigen receptors (CARs). Fate Therapeutics is
headquartered in San Diego, CA. For more information, please visit
www.fatetherapeutics.com.
Fate Therapeutics Forward-Looking
StatementsThis release contains "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995, including statements regarding the impact,
timing, conduct and the potential benefits of the collaboration,
including expected funding and payments to be received by Fate
Therapeutics under the collaboration, as well as the advancement
of, plans related to, and the therapeutic potential of the
Company's product candidates, the Company’s clinical development
strategies, and the Company’s plans for the clinical investigation
of its product candidates, including FT825/ONO-8250. 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, risks associated
with: the possibility that the results observed in studies of its
product candidates, including preclinical studies and clinical
trials of any of its product candidates, will not be observed in
ongoing or future studies involving these product candidates; the
success, cost and timing of product development activities under
the collaboration; the ability of Fate Therapeutics and ONO
Pharmaceutical to obtain regulatory approval for and to
commercialize any product candidates developed under the
collaboration; regulatory requirements and regulatory developments;
the success of competing treatments and technologies; the risk of
cessation or delay of any development activities under the
collaboration for a variety of reasons; any adverse effects or
events, or other negative results, that may be observed in
preclinical or clinical development of any product candidates
developed through the collaboration; and the risk that funding and
payments received by Fate Therapeutics under the collaboration may
be less than expected. For a discussion of other risks and
uncertainties, and other important factors, any of which could
cause Fate Therapeutics’ actual results to differ from those
contained in the forward-looking statements, see the risks and
uncertainties detailed in Fate Therapeutics’ periodic filings with
the Securities and Exchange Commission, including but not limited
to Fate Therapeutics’ most recently filed periodic report, and from
time to time in Fate Therapeutics’ press releases and other
investor communications. Fate Therapeutics is providing the
information in this release as of this date and, except as required
by law, 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@sternir.com
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