Fate Therapeutics Announces FDA Clearance of Investigational New Drug Application for FATE-NK100 in Advanced Solid Tumors
May 10 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 authorized the Company’s investigational
new drug (IND) application for FATE-NK100 in advanced solid tumors.
The Company plans to promptly initiate the DIMENSION study, an
open-label, multi-center, accelerated dose-escalation clinical
trial of FATE-NK100 as a monotherapy and in combination with
monoclonal antibody therapy in subjects who have failed approved
therapies.
“The FDA’s clearance of this IND is a significant milestone,
ushering in the opportunity to develop a powerful new immunologic
approach to solid tumors that bridges innate and adaptive immunity.
Activated NK cells can intrinsically seek out and directly kill
transformed cancer cells, including antibody-coated tumor cells,
and can trigger a long-lived adaptive T-cell immune response
through pro-inflammatory cytokine release,” said Chris Storgard,
M.D., Chief Medical Officer of Fate Therapeutics. “We are excited
to begin this clinical investigation of FATE-NK100, which has
demonstrated in preclinical studies the potential to selectively
eliminate tumor cells while leaving normal healthy cells
unharmed.”
The Company plans to enroll subjects in the DIMENSION study
across three FATE-NK100 treatment arms in an outpatient setting: as
monotherapy for solid tumor malignancies, including small cell lung
cancer and hepatocellular carcinoma; in combination with
trastuzumab for advanced HER2+ cancers, including breast and
gastric cancers; and in combination with cetuximab for advanced
EGFR1+ cancers, including colorectal and head and neck cancers.
Activation of a patient’s NK cells has been clinically proven to
play a major role in the anti-tumor efficacy of many monoclonal
antibodies, including trastuzumab and cetuximab.
In preclinical models, FATE-NK100 has been shown 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. Additionally, FATE-NK100 has displayed enhanced
anti-tumor activity across a broad range of hematologic and solid
tumors, improved persistence and increased resistance to immune
checkpoint pathways in preclinical studies compared to NK cell
therapies that are being clinically administered today.
The primary objective of the DIMENSION study is to evaluate the
safety and determine the maximum tolerated dose of a single
intravenous infusion of FATE-NK100. Other objectives include
determination of objective response rate, time-to-tumor
progression, progression-free survival and overall survival. Each
of the three arms of the DIMENSION study will enroll in parallel
utilizing accelerated dose-escalation, with each arm expected to
include an expansion cohort of up to an additional twenty subjects
at the maximum tolerated dose level. In addition, observation of a
RECIST partial response or greater will enable additional expansion
of up to ten subjects in that tumor type.
About FATE-NK100
FATE-NK100 is a first-in-class natural killer (NK) cell cancer
immunotherapy comprised of adaptive memory NK cells, a highly
specialized and functionally distinct subset of activated NK cells
expressing the memory-like activating receptor NKG2C and the
maturation marker CD57. FATE-NK100 is produced through a
feeder-free, seven-day manufacturing process during which NK cells
sourced from a healthy donor are activated ex vivo with
pharmacologic modulators. An investigator-initiated clinical trial
of FATE-NK100 is currently being conducted at the Masonic Cancer
Center, University of Minnesota for the treatment of refractory or
relapsed acute myelogenous leukemia.
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, our clinical development plans
for FATE-NK100, including the timing of, and our ability to
conduct, clinical studies, and the potential of FATE-NK100 to treat
patients with cancer, including advanced solid tumors, as a
monotherapy and in combination with monoclonal antibody therapy.
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 or other ongoing clinical studies of FATE-NK100 may not be
replicated in current or 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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