Fate Therapeutics to Host Virtual Event Highlighting Interim Phase 1 Clinical Data from its Off-the-Shelf, iPSC-derived NK Ce...
July 16 2021 - 8:00AM
Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage
biopharmaceutical company dedicated to the development of
programmed cellular immunotherapies for cancer, today announced
that management will host a virtual event to highlight interim
Phase 1 clinical data from its FT596 and FT516 programs for the
treatment of relapsed / refractory B-cell lymphomas on August 19,
2021 at 4:30 p.m. ET.
The live webcast of the presentation can be accessed under
"Events & Presentations" in the Investors section of the
Company's website at www.fatetherapeutics.com. The archived webcast
will be available on the Company's website beginning approximately
two hours after the event.
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 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
350 issued patents and 150 pending patent applications.
About FT516FT516 is an
investigational, universal, off-the-shelf natural killer (NK) cell
cancer immunotherapy derived from a clonal master induced
pluripotent stem cell (iPSC) line engineered to express a novel
high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which
has been modified to prevent its down-regulation and to enhance its
binding to tumor-targeting antibodies. CD16 mediates
antibody-dependent cellular cytotoxicity (ADCC), a potent
anti-tumor mechanism by which NK cells recognize, bind and kill
antibody-coated cancer cells. ADCC is dependent on NK cells
maintaining stable and effective expression of CD16, which has been
shown to undergo considerable down-regulation in cancer patients.
In addition, CD16 occurs in two variants, 158V or 158F, that elicit
high or low binding affinity, respectively, to the Fc domain of
IgG1 antibodies. Numerous clinical studies with FDA-approved
tumor-targeting antibodies, including rituximab, trastuzumab and
cetuximab, have demonstrated that patients homozygous for the 158V
variant, which is present in only about 15% of patients, have
improved clinical outcomes. FT516 is being investigated in a
multi-dose Phase 1 clinical trial as a monotherapy for the
treatment of acute myeloid leukemia and in combination with
CD20-targeted monoclonal antibodies for the treatment of advanced
B-cell lymphoma (NCT04023071). Additionally, FT516 is being
investigated in a multi-dose Phase 1 clinical trial in combination
with avelumab for the treatment of advanced solid tumor resistant
to anti-PDL1 checkpoint inhibitor therapy (NCT04551885).
About FT596FT596 is an
investigational, universal, off-the-shelf natural killer (NK) cell
cancer immunotherapy derived from a clonal master induced
pluripotent stem cell (iPSC) line engineered with three anti-tumor
functional modalities: a proprietary chimeric antigen receptor
(CAR) optimized for NK cell biology that targets B-cell antigen
CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc
receptor, which has been modified to prevent its down-regulation
and to enhance its binding to tumor-targeting antibodies; and an
IL-15 receptor fusion (IL-15RF) that augments NK cell activity. In
preclinical studies of FT596, the Company has demonstrated that
dual activation of the CAR19 and hnCD16 targeting receptors
enhances cytotoxic activity, indicating that multi-antigen
engagement may elicit a deeper and more durable response.
Additionally, in a humanized mouse model of lymphoma, FT596 in
combination with the anti-CD20 monoclonal antibody rituximab showed
enhanced killing of tumor cells in vivo as compared to rituximab
alone. FT596 is being investigated in a multi-center Phase 1
clinical trial for the treatment of relapsed / refractory B-cell
lymphoma as a monotherapy and in combination with rituximab, and
for the treatment of relapsed / refractory chronic lymphocytic
leukemia (CLL) as a monotherapy and in combination with
obinutuzumab (NCT04245722).
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.
Contact:Christina TartagliaStern Investor
Relations, Inc.212.362.1200christina@sternir.com
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