Fate Therapeutics Secures Exclusive Option to Novel Humanized anti-BCMA CAR Constructs for Development of iPSC-derived Cell P...
December 03 2018 - 4:01PM
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 it has secured an exclusive option
to an intellectual property portfolio owned by the Max Delbrück
Center for Molecular Medicine (MDC) covering novel humanized
chimeric antigen receptor (CAR) constructs that uniquely and
specifically bind B-cell Maturation Antigen (BCMA). Under the
agreement with MDC, Fate Therapeutics holds an exclusive option to
exclusively license the portfolio for all cell products, including
CAR NK- and T-cell products, derived from induced pluripotent stem
cells (iPSCs).
“BCMA is a validated target for cancer immunotherapy, and we are
particularly impressed with the innovative work of MDC in
developing superior approaches to engage BCMA with higher affinity
and greater specificity,” said Scott Wolchko, President and Chief
Executive Officer of Fate Therapeutics. “We look forward to
incorporating MDC’s humanized antigen-binding domains into our
proprietary CAR constructs for NK cells and T cells, and applying
our industry-leading iPSC product platform to develop universal,
off-the-shelf cell products for multiple myeloma and other
BCMA-positive malignancies.”
Last week, Fate Therapeutics announced that the U.S. Food and
Drug Administration (FDA) has 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. The Company’s iPSC-derived cell product platform
overcomes significant challenges that limit both patient- and
donor-derived cell therapy, where heterogeneous populations of
primary cells are repeatedly sourced, engineered, expanded and
characterized on a batch-by-batch basis resulting in cell therapies
with substantial variability in quality, consistency and
potency.
In a recent publication entitled “CAR T Cells with Enhanced
Sensitivity to B Cell Maturation Antigen for the Targeting of B
Cell Non-Hodgkin’s Lymphoma and Multiple Myeloma”
(doi:10.1016/j.ymthe.2018.06.012), scientists from MDC demonstrated
that anti-BCMA CAR T cells equipped with its unique humanized
extracellular antigen-binding domains have higher affinity and
greater specificity than other anti-BCMA antigen-binding domains.
These differentiated properties provided both greater selectivity
in recognizing target B cells and more robust killing of target B
cells in vitro, including malignant B cells with low expression
levels of BCMA. Additionally, in in vivo proof-of-concept studies,
its anti-BCMA CAR T cells mediated anti-tumor activity in
xenotransplant mouse models of multiple myeloma as well as mature
B-cell non-Hodgkin lymphoma, where BCMA surface expression is up to
4-fold lower as compared to multiple myeloma cells.
Fate Therapeutics is applying its iPSC product platform, which
utilizes clonal master engineered iPSC lines to mass produce NK-
and T-cell products that are uniformly engineered and extensively
characterized, to create off-the-shelf cell-based cancer
immunotherapies for multiple myeloma. The intellectual property of
MDC covered under the exclusive option includes humanized antibody
fragments that bind a unique BCMA epitope, humanized CAR constructs
with extracellular antigen-binding domains to BCMA, and immune
cells, including NK cells and T cells, expressing anti-BCMA CAR
constructs.
About Fate Therapeutics’ iPSC Product
Platform The 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.
Fate Therapeutics Forward-Looking
Statements This release contains
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
regarding the breadth and scope of the MDC intellectual property
and the scope and enforceability of the Company’s intellectual
property rights, the advancement of and plans related to the
Company’s research and development of iPSC-derived cell products
for the treatment of cancer, including the safety and therapeutic
potential of such products, and the Company’s plans and timing for
its intended clinical investigation of 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, risks related to the
Company’s ability to negotiate and execute a definitive license
agreement with MDC, the risk that any patents that may issue from
the MDC patent applications will not provide adequate protection
for the Company’s product candidates, risks relating to the
Company’s ability to protect and maintain its intellectual property
position, the risk that any of the patents or patent applications
owned or licensed by the Company may be challenged and that such a
challenge may be successful, resulting in loss of any such patent
claims or loss or reduction in the scope of one or more of the
claims of a such patent, 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 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 Tartaglia Stern Investor
Relations, Inc. 212.362.1200 christina@sternir.com
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