Fate Therapeutics Announces FDA Clearance of Investigational New Drug Application for FATE-NK100 Natural Killer Cell Cancer I...
March 13 2017 - 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 U.S. Food and Drug
Administration (FDA) has cleared an investigational new drug
application for FATE-NK100, the Company’s first-in-class adaptive
memory natural killer (NK) cell product candidate. The Company
expects a first-in-human clinical trial of FATE-NK100 for advanced
acute myeloid leukemia (AML) to open enrollment at the Masonic
Cancer Center, University of Minnesota following approval of the
Center’s institutional review board.
“AML patients who relapse or are refractory to front-line
therapy have very poor prognoses and very few treatment options,
and we have shown that natural killer cell immunotherapy is a safe
and efficacious approach to target and durably destroy leukemia
cells in these patients,” said Sarah Cooley, M.D., Associate
Professor of Medicine, Division of Hematology, Oncology and
Transplantation at the University of Minnesota and the clinical
trial’s lead investigator. “FATE-NK100 is a next-generation
immunotherapy that is uniquely tailored to fully realize the
anti-cancer activity of natural killer cells, and we are excited to
pioneer the clinical investigation of this novel NK cell
therapy.”
FATE-NK100 is comprised of adaptive memory NK cells, a highly
specialized and functionally distinct subset of natural killer
cells expressing the memory-like activating receptor NKG2C and the
maturation marker CD57. Adaptive memory NK cells have been
clinically shown to have potent and persistent effector function in
patients with AML.
“FATE-NK100 is a first-in-class NK cell product candidate
designed to enhance direct tumor cell killing, resist immune
checkpoints and promote endogenous T-cell anti-tumor response,”
said Scott Wolchko, President and Chief Executive Officer of Fate
Therapeutics. “We look forward to exploiting the multifaceted
effector function of these adaptive memory NK cells across liquid
and solid tumors, both as a monotherapy and in combination with
therapeutic antibodies.”
Unlike T cells that require specific tumor antigen recognition
to elicit an effective immune response, natural killer cells
selectively identify and destroy cancer cells through recognition
of a repertoire of stress signals commonly expressed across tumor
cell types, while leaving normal healthy cells unharmed.
Additionally, while T-cell immunotherapy most commonly requires a
patient-specific treatment approach, natural killer cells sourced
from healthy donors have been safely administered to patients for
over a decade without causing graft-versus-host disease or
triggering significant side effects, such as cytokine release
syndrome.
The first-in-human study will evaluate the safety and determine
the maximum dose of a single intravenous infusion of FATE-NK100 in
subjects with refractory or relapsed AML. Secondary and
investigational endpoints will assess anti-tumor activity including
rates of complete response, clearance of minimal residual disease,
disease-free survival and overall survival. The clinical trial will
utilize an accelerated dose escalation design, which is intended to
test up to four dose levels of FATE-NK100 with one subject enrolled
per dose level until a dose-limiting toxicity (DLT) is observed.
The study will convert to a 3+3 design in the event a DLT is
observed, and will enroll a ten subject expansion cohort at the
maximum dose level.
FATE-NK100 has demonstrated in preclinical studies enhanced
anti-tumor activity across a broad range of liquid and solid
tumors, improved persistence and increased resistance to immune
checkpoint pathways compared to NK cell therapies that are being
clinically administered today. Additionally, FATE-NK100 has been
shown in preclinical models to significantly augment
antibody-directed cellular cytotoxicity against cancer cells when
administered in combination with a monoclonal antibody, including
antibodies that target CD20, HER2 and EGFR antigens. FATE-NK100 is
produced through a feeder-free, seven-day manufacturing process
during which natural killer cells sourced from a healthy donor are
activated ex vivo with pharmacologic modulators, inducing the
robust formation of adaptive memory NK cells.
About Fate Therapeutics, Inc.Fate Therapeutics
is a clinical-stage biopharmaceutical company dedicated to the
development of programmed cellular immunotherapies for cancer and
immune disorders. The Company's hematopoietic cell therapy pipeline
is comprised of NK- and T-cell immuno-oncology programs, including
off-the-shelf product candidates derived from engineered induced
pluripotent cell lines, and immuno-regulatory programs, including
product candidates to prevent life-threatening complications in
patients undergoing hematopoietic cell transplantation and to
promote immune tolerance in patients with autoimmune disease. Its
adoptive cell therapy programs are based on the Company's novel ex
vivo cell programming approach, which it applies to modulate the
therapeutic function and direct the fate of immune cells. Fate
Therapeutics is headquartered in San Diego, CA. For more
information, please visit www.fatetherapeutics.com.
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 safety and therapeutic potential of NK
cells including FATE-NK100, the timing of the initiation of, and
expected clinical trial design for, the clinical investigation of
FATE-NK100, and the potential of FATE-NK100 to treat patients with
AML and other cancers. 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 cessation or delay of planned
development and clinical activities for a variety of reasons
(including any delay in initiating or enrolling patients in
clinical trials, or the occurrence of any adverse events or other
results that may be observed during development), the risk that
results observed in prior preclinical studies of FATE-NK100 may not
be replicated in subsequent studies or clinical trials, and the
risk that FATE-NK100 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 our 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 the
Company’s 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 Tartaglia
Stern Investor Relations, Inc.
212.362.1200
christina@sternir.com
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