Fate Therapeutics Announces Off-the-Shelf CAR T-cell Cancer Immunotherapy to be Featured at 2018 AACR Annual Meeting Press Pr...
April 16 2018 - 9:30AM
Off-the-Shelf CAR T-cell Product Candidate
Designed to Target CD19-positive Tumor Cells and to Overcome
Antigen Escape
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 is presenting new
preclinical data on FT819, its off-the-shelf CAR T-cell product
candidate, at the American Association for Cancer Research (AACR)
Annual Meeting being held from April 14-18, 2018 in Chicago,
Illinois.
The presentation of FT819 was accepted by AACR as a
late-breaking abstract, and was subsequently selected by AACR to be
featured at the AACR Annual Meeting press program being held today
at 8:30 a.m. CT.
FT819 is an off-the-shelf CAR T-cell product candidate produced
from a master induced pluripotent stem cell (iPSC) line. FT819 has
two targeting receptors, a chimeric antigen receptor (CAR)
targeting CD19-positive tumor cells and a CD16 Fc receptor that can
engage other proven cancer therapies, such as tumor
antigen-targeting monoclonal antibody (mAb)-based treatments, to
overcome antigen escape. Fate Therapeutics is developing FT819 as
part of a research collaboration being led by Michel Sadelain,
M.D., Ph.D., Director, Center for Cell Engineering, Memorial Sloan
Kettering Cancer Center.
In preclinical studies, FT819 exhibited an efficient cytotoxic
T-cell response in vitro when challenged with CD19-positive tumor
cells, displaying robust production of effector cytokines,
including INF-gamma and TNF-alpha, and cytolytic proteins,
including perforin and granzyme B. The product candidate’s activity
was also found to be target-specific in vitro, attacking only
CD19-positive tumor cells and sparing CD19-negative tumor cells.
Additionally, when combined with a mAb-based treatment targeting
CD20, FT819 was shown to elicit antibody-dependent cell-mediated
cytotoxicity (ADCC) in vitro against CD19-negative, CD20-positive
tumor cells through CD16 engagement.
The master iPSC line used for the production of FT819 is
engineered in a one-time event to insert CAR19 into the T-cell
receptor α constant (TRAC) locus for enhanced safety and potency
and to completely eliminate T-cell receptor (TCR) expression. The
line serves as a renewable source for consistently and repeatedly
manufacturing homogeneous cell products in quantities that support
the treatment of many thousands of patients in an off-the-shelf
manner. This approach eliminates the need to create a personalized
therapy from a patient’s own cells, enables mass production at
scale and significantly reduces the cost of, and time to, patient
treatment.
The data is also being presented by the Company in a poster
session.
Presentation: Generation of
off-the-shelf TCR-less CAR-targeted cytotoxic T cells from
renewable pluripotent cells for cancer
immunotherapySession: Late-Breaking Poster Session
– ImmunologyTime and Date: 8:00 a.m. - 12:00 p.m.
CT, Monday, April 16, 2018Location: McCormick
Place South (Level 3), Exhibit Hall A, Section 45, Poster LB-108 /
5
Following presentation at the meeting, the AACR press program
and poster presentations will be available on the Company’s website
at www.fatetherapeutics.com.
About Fate Therapeutics’ iPSC Product
PlatformThe Company’s proprietary iPSC product platform
enables mass production of off-the-shelf, engineered, homogeneous
cell products that can be administered in repeat doses to mediate
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
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 consistently and repeatedly
manufacturing homogeneous cell products in quantities that support
the treatment of many thousands of patients in an off-the-shelf
manner. Fate Therapeutics’ iPSC product platform is supported by an
intellectual property portfolio of over 90 issued patents and 100
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 is pioneering the development of
off-the-shelf cell products using its proprietary induced
pluripotent stem cell (iPSC) product platform. The Company’s
immuno-oncology pipeline is comprised of FATE-NK100, a
donor-derived natural killer (NK) cell cancer immunotherapy that is
currently being evaluated in three Phase 1 clinical trials, as well
as iPSC-derived NK cell and T-cell immunotherapies, with a focus on
developing augmented cell products intended to synergize with
checkpoint inhibitor and monoclonal antibody therapies and to
target tumor-specific antigens. The Company’s immuno-regulatory
pipeline includes ProTmune™, a next-generation 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 advancement of and plans related to its
research and development of iPSC-derived cellular immunotherapies
and off-the-shelf CAR T-cell products, including the safety and
therapeutic potential of such therapies, the Company’s progress and
plans for the manufacture and development of FT819, and the
Company’s expected product development and regulatory strategy, and
associated timelines, for its iPSC-derived cellular immunotherapies
and off-the-shelf CAR T-cell products, including FT819. 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
results observed in prior preclinical studies of any of its
iPSC-derived cellular immunotherapies, including any off-the-shelf
CAR T-cell products, will not be observed in ongoing or future
studies involving these product candidates, the risk that the
Company may cease or delay development of any of its iPSC-derived
cellular immunotherapies, including any off-the-shelf CAR T-cell
products, 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 any of the its iPSC-derived cellular
immunotherapies, including any off-the-shelf CAR T-cell products,
for preclinical or clinical testing, difficulties or delays in
subject enrollment in planned clinical trials, and any adverse
events or other negative results that may be observed during
preclinical or clinical development), and the risk that any of its
iPSC-derived cellular immunotherapies, including any off-the-shelf
CAR T-cell products, may not be suitable for therapeutic
applications and may not provide the anticipated therapeutic
benefits. 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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