Fate Therapeutics Presents Off-the-Shelf CAR T and NK Cell Cancer Immunotherapy Pipeline at ASH Annual Meeting
December 04 2018 - 9:11AM
Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage
biopharmaceutical company dedicated to the development of
programmed cellular immunotherapies for cancer and immune
disorders, announced new preclinical data on the Company’s induced
pluripotent stem cell (iPSC) product platform and its iPSC-derived,
off-the-shelf cell-based cancer immunotherapy pipeline at the 60th
American Society of Hematology (ASH) Annual Meeting and Exposition.
Last week, the Company announced that the U.S. Food and Drug
Administration (FDA) allowed its Investigational New Drug (IND)
Application for FT500, the Company’s universal, off-the-shelf
natural killer (NK) cell product candidate derived from a clonal
master iPSC line. The clinical trial of FT500 is expected to be the
first-ever clinical investigation in the U.S. of an iPSC-derived
cell product.
“Fate Therapeutics is at the forefront in
developing off-the-shelf, cell-based cancer immunotherapies, and is
rapidly progressing multiple iPSC-derived CAR T- and NK cell
product candidates that have the potential to disrupt autologous
and allogeneic approaches to cell therapy,” said Scott Wolchko,
President and Chief Executive Officer of Fate Therapeutics. “The
clearance of our FT500 IND by the FDA is a landmark achievement and
serves as a roadmap for advancement of our iPSC-derived cell
product pipeline into clinical development. We believe the use of
clonal master iPSC lines uniquely enables the production of
multi-functional, cell-based cancer immunotherapies that are
uniformly engineered, are available for off-the-shelf
administration to patients and can be effectively combined in
multi-dose, multi-cycle regimens with well-established
immune-oncology agents, such as checkpoint inhibitor blockade and
monoclonal antibody therapy, including in earlier lines of
therapy.”
Several of the Company’s iPSC-derived cell
product candidates undergoing development were discussed during an
investor event at ASH by its collaborating experts in the field of
cell-based cancer immunotherapy including:
- Michel Sadelain, M.D., Ph.D., Director, Center for Cell
Engineering & Gene Transfer and Gene Expression Laboratory,
Memorial Sloan Kettering Cancer Center;
- Jeffrey S. Miller, M.D., Deputy Director, Masonic Cancer
Center, University of Minnesota; and
- Dan S. Kaufman, M.D., Ph.D., Professor of Medicine, Division of
Regenerative Medicine, Director of Cell Therapy, University of
California – San Diego.
FT500The clinical trial of
FT500 is intended to evaluate the safety and tolerability of
multiple doses of FT500, in multiple dosing cycles with nivolumab,
pembrolizumab or atezolizumab, in subjects that have progressed or
failed on immune checkpoint blockade (CPB) therapy. Although CPB
therapy can lead to prolonged responses, refractory disease and
progression after initial response remain major causes of
mortality. In patients receiving CPB therapy, mutations in
beta-2-microglobulin (B2M), an essential component for the stable
presentation of antigens by tumor cells, have been identified in
approximately 30% of patients with progressing disease and are
associated with poor overall survival. Investigators have
demonstrated in various tumor model systems that NK cells have the
potential to rescue CPB therapy by recognizing and killing
B2M-deficient target cells. An oral presentation at ASH by Dr.
Miller showed that FT500 synergizes with T cells and anti-PD1
antibody to produce pro-inflammatory cytokines and completely clear
target cancer cells in an in vitro three-dimensional tumor spheroid
model.
FT516FT516 is a universal,
off-the-shelf NK cell product candidate manufactured from a clonal
master iPSC line engineered to uniformly express a high-affinity,
non-cleavable CD16 (hnCD16) Fc receptor. Since CD16 binds the Fc
region of tumor-bound antibodies, FT516 can be combined with
FDA-approved monoclonal antibody therapies to target a broad
spectrum of tumor-associated antigens. In preclinical studies,
FT516 exhibits potent and persistent anti-tumor activity in vitro
and in vivo against multiple tumor types, including in combination
with monoclonal antibody therapies that target CD20, HER2 and EGFR.
The Company plans to submit an IND to the FDA by the end of 2018 to
evaluate the safety and tolerability of multiple doses of FT516 in
multiple dosing cycles in combination with FDA-approved monoclonal
antibody therapy.
FT596FT596 is a universal,
off-the-shelf chimeric antigen receptor (CAR) NK cell product
candidate that expresses a proprietary CAR targeting CD19, a novel
IL-15 receptor fusion for cytokine-independent persistence, and a
hnCD16 Fc receptor for augmented antibody-dependent
cellular-cytotoxicity (ADCC). A poster presentation at ASH by
scientists from the Company and the University of California – San
Diego highlighted new in vivo data demonstrating that FT596
displays long-term persistence without systemic cytokine support.
Additionally, FT596 prevents tumor progression and promotes
sustained long-term survival in a B-cell leukemia xenograft model.
Moreover, as proof-of-concept for the mitigation of antigen escape,
FT596 in combination with rituximab completely eliminates CD19+ and
CD19- B-cell tumor cells in a co-culture cytotoxicity assay.
FT538FT538 is a universal,
off-the-shelf NK cell product candidate that expresses both a novel
IL-15 receptor fusion for cytokine-independent persistence and a
hnCD16 Fc receptor for augmented ADCC, and additionally lacks CD38
expression to eliminate fratricide when combined with
CD38-targeting monoclonal antibody therapy. A poster presentation
at ASH by scientists from the Company and the University of
Minnesota highlighted new in vitro data showing that FT538 in
combination with daratumumab is resistant to fratricide and
eliminates multiple myeloma cancer cells in a serial re-challenge
assay. The Company is investigating the additional therapeutic
benefit of including a novel humanized CAR targeting B-cell
Maturation Antigen (BCMA) as a dual-targeting mechanism to address
multiple myeloma and other BCMA-positive malignancies.
FT819FT819 is an off-the-shelf,
TCR-less CD19 CAR T-cell product candidate manufactured from a
clonal master iPSC line that is undergoing preclinical development
under a collaboration with Memorial Sloan Kettering Cancer Center
(MSK) led by Dr. Sadelain. FT819 is engineered to completely
eliminate expression of the T-cell receptor and to insert a
next-generation CAR receptor into the T-cell receptor alpha locus,
a strategy which is intended to convey enhanced safety and efficacy
while eliminating the possibility of graft-versus-host disease. A
poster presentation at ASH by scientists from the Company and MSK
showcased new in vivo data demonstrating that FT819, when thawed
and directly infused, effectively controls tumor progression
comparable to peripheral blood CAR T cells in a preclinical mouse
model of acute lymphoblastic leukemia.
A copy of the Company’s presentation from its
ASH investor event can be accessed under "Events &
Presentations" in the Investors & Media section of 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 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 to treat many patients. Fate
Therapeutics’ iPSC product platform is supported by an intellectual
property portfolio of over 100 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 advancement of and plans related to the
Company's product candidates and planned clinical studies, the
therapeutic potential of the Company’s iPSC-derived NK cell and
T-cell product candidates, the Company’s regulatory strategy, and
the Company’s plans for its intended clinical investigation of
FT500 and FT516. 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 any planned clinical studies, or in the enrollment or
evaluation of subjects in any future clinical studies, 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), the risk that
results observed in preclinical studies of its iPSC-derived cell
product candidates may not be replicated in ongoing or future
clinical trials or studies, and the risk that its iPSC-derived cell
product candidates may not produce therapeutic benefits or may
cause other unanticipated adverse effects. 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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