Fate Therapeutics Announces the Opening of its cGMP Manufacturing Facility Dedicated to iPSC-derived Cell Therapies
September 30 2019 - 8:00AM
Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage
biopharmaceutical company dedicated to the development of
programmed cellular immunotherapies for cancer and immune
disorders, announced today that the Company has opened its current
Good Manufacturing Process (cGMP) compliant manufacturing facility
for the clinical production of its off-the-shelf natural killer
(NK) cell and chimeric antigen receptor (CAR) T-cell product
candidates. The Company’s cGMP facility, located in San Diego,
California, is custom designed for the manufacture of off-the-shelf
allogeneic cell products using clonal master induced pluripotent
stem cell (iPSC) lines as a starting cell source. The new
state-of-the-art facility has been commissioned and qualified, and
the Company has been issued a drug manufacturing license by the
State of California, Department of Health Services, Food and Drug
Branch.
“The on-time launch of our cGMP manufacturing facility is a
significant milestone that positions the Company as the leading
manufacturer and developer of off-the-shelf NK cell and CAR-T cell
cancer immunotherapies,” said Scott Wolchko, President and Chief
Executive Officer of Fate Therapeutics. “With full control of cGMP
production, combined with our proven ability to
genetically-engineer induced pluripotent stem cells and create
clonal master iPSC banks qualified for clinical use, we believe we
have established operational capabilities unique to the industry to
ensure consistent, large-scale, and cost-effective manufacture of
best-in-class off-the-shelf cell products for on-demand delivery to
patients.”
In early September, Fate Therapeutics announced that the U.S.
Food and Drug Administration (FDA) cleared the Company’s
Investigational New Drug (IND) application for FT596, its
off-the-shelf, iPSC-derived CAR NK cell product candidate
engineered to target multiple tumor-associated antigens, for the
treatment of B-cell lymphoma and chronic lymphocytic leukemia.
The Company is also conducting first-in-human clinical trials of
FT516, an off-the-shelf, iPSC-derived NK cell product candidate
engineered to express a novel high-affinity, non-cleavable CD16
(hnCD16) Fc receptor, for the treatment of acute myeloid leukemia
and B-cell lymphoma, and FT500, an off-the-shelf, iPSC-derived NK
cell product candidate, for the treatment of advanced solid
tumors.
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 can be
administered with multiple doses to deliver more effective
pharmacologic activity, including in combination with cycles of
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 capable of overcoming 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 250 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 cancer
and immune disorders. 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 product candidates include natural killer (NK) cell
and T-cell cancer immunotherapies, which are designed to synergize
with well-established cancer therapies, including immune checkpoint
inhibitors and monoclonal antibodies, and to target
tumor-associated antigens with chimeric antigen receptors (CARs).
The Company’s immuno-regulatory product candidates include
ProTmune™, a pharmacologically modulated, donor cell graft that is
currently being evaluated in a Phase 2 clinical trial for the
prevention of graft-versus-host disease, and a myeloid-derived
suppressor cell immunotherapy for promoting immune tolerance in
patients with immune disorders. 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 Company’s progress, plans and timelines for the
manufacture of its product candidates, including timing for
initiation of manufacturing at its new manufacturing facility, the
advancement of and plans related to the Company's product
candidates and clinical studies, the therapeutic potential of the
Company’s cell product candidates, and the Company’s clinical
development strategy for FT596, FT516 and FT500. 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 of
difficulties or delay in the initiation of manufacturing at the
Company’s new manufacturing facility, the risk that the Company may
not realize the potential benefits of this new manufacturing
facility and the risk that this new facility may not be fully
operational in the currently anticipated timelines, the risk of
difficulties or delay in the initiation of any planned clinical
studies, and 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 or to support regulatory approval,
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). 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@sternir.com
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