Fate Therapeutics Announces First Subject Treated with FATE-NK100 in DIMENSION Study for Advanced Solid Tumors
February 20 2018 - 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 first subject has been treated
in the DIMENSION study of FATE-NK100 for the treatment of advanced
solid tumors. The clinical trial is intended to evaluate the safety
and determine the maximum dose of FATE-NK100, the Company’s
first-in-class, allogeneic donor-derived adaptive memory natural
killer (NK) cell cancer therapy, when administered as a monotherapy
and in combination with trastuzumab or cetuximab, two FDA-approved
targeted monoclonal antibody therapies that are widely used today
to treat various cancers.
“Patients with cancer often have deficient or dysfunctional
natural killer cells. The co-administration of FATE-NK100 alongside
a targeted monoclonal antibody therapy is a novel approach to
restore a patient’s immune cell function and to selectively
recognize and kill antibody-coated tumor cells,” said Manish R.
Patel, D.O., Assistant Professor of Medicine, Division of
Hematology, Oncology and Transplantation at the University of
Minnesota and the lead investigator of the clinical trial at the
Masonic Cancer Center. “We are excited to have initiated what we
believe to be the first clinical investigation of healthy
allogeneic donor NK cell therapy in combination with FDA-approved
monoclonal antibody therapy for solid tumor malignancies. This new
treatment paradigm holds great promise for cancer patients who have
progressed on or failed monoclonal antibody therapy and have no
other therapeutic options.”
Monoclonal antibodies are a well-established class of cancer
immunotherapy agents designed to selectively target and bind to
proteins on the surface of tumor cells. Compelling clinical data
indicate that NK cells mediate the therapeutic effect of monoclonal
antibody therapy by recognizing and efficiently killing
antibody-coated tumor cells via a potent immune response mechanism
known as antibody-dependent cellular cytotoxicity (ADCC). The
combination of FATE-NK100 and monoclonal antibody therapy is
designed to enhance ADCC by administering an activated population
of healthy allogeneic donor NK cells to augment the killing of
antibody-coated tumor cells. It is estimated that the worldwide
market for cancer monoclonal antibodies is over $30 billion, and is
poised to reach $45 billion by the end of 2020.
DIMENSION is the third clinical trial of FATE-NK100 currently
being conducted. FATE-NK100 is also being clinically
investigated in the VOYAGE study for the treatment of refractory or
relapsed acute myelogenous leukemia and in the APOLLO study for the
treatment of ovarian cancer resistant to, or recurrent on,
platinum-based treatment.
About DIMENSIONDIMENSION is a multi-center,
open-label, accelerated dose-escalation Phase 1 clinical trial of
FATE-NK100 in subjects with advanced solid tumors who have
progressed on or failed available approved therapies. The clinical
trial is designed to evaluate the safety and determine the maximum
dose of a single intravenous infusion of FATE-NK100 when
administered as a monotherapy and in combination with monoclonal
antibody therapy after outpatient lymphoconditioning therapy
followed by sub-cutaneous IL-2 administration. Other endpoints to
be assessed include objective response rates and progression-free
and overall survival.
The clinical trial is being conducted across three independent
treatment arms: (i) as a monotherapy for advanced solid tumor
malignancies, including small cell lung cancer and hepatocellular
carcinoma; (ii) in combination with trastuzumab for advanced human
epidermal growth factor receptor 2 positive (HER2+) cancers,
including breast and gastric cancers; and (iii) in combination with
cetuximab for advanced epidermal growth factor receptor 1 positive
(EGFR1+) cancers, including colorectal and head and neck cancers.
In the combination arms, subjects will receive the monoclonal
antibody therapy two days prior to and seven days following
administration of FATE-NK100. Subjects with evidence of tumor
shrinkage at Day 29 following administration of FATE-NK100 may be
considered for retreatment.
Up to three dose levels in the monotherapy arm, and up to four
dose levels in the monoclonal antibody therapy arms, of FATE-NK100
are intended to be assessed. In the event a dose limiting toxicity
is observed in an arm, the arm will convert to a 3+3 design.
Following dose escalation, expansion cohorts of 20 subjects per arm
may be enrolled.
About FATE-NK100FATE-NK100 is a first-in-class,
allogeneic donor-derived 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 maturation marker CD57. Higher frequencies of CD57+
NK cells in the peripheral blood or tumor microenvironment in
cancer patients have been linked to better clinical outcomes. In
preclinical studies, FATE-NK100 has demonstrated enhanced
anti-tumor activity across a broad range of hematologic and solid
tumors, with augmented cytokine production, improved persistence,
enhanced antibody-dependent cellular cytotoxicity and increased
resistance to immune checkpoint pathways compared to other NK cell
therapies that are being clinically administered today. FATE-NK100
is produced through a feeder-free, seven-day manufacturing process
during which NK cells sourced from a healthy allogeneic donor are
activated ex vivo with pharmacologic modulators. In August 2017,
non-clinical data describing the unique properties and anti-tumor
activity of FATE-NK100 were published by Cancer Research
(doi:10.1158/0008-5472.CAN-17-0799), a peer-reviewed journal of
the American Association of Cancer Research.
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 therapies using
its proprietary induced pluripotent stem cell (iPSC) product
platform. This platform uniquely enables the single-cell selection
of a precisely engineered iPSC clone and the subsequent creation
and maintenance of 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 generating homogeneous cell products in quantities that
support the treatment of many thousands of patients in an
off-the-shelf manner. 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 other NK cell and T-cell
immunotherapies, with a focus on developing augmented cell products
intended to synergize with checkpoint inhibitor and monoclonal
antibody therapies. 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 to promote 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 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 expected clinical development plans
for FATE-NK100, and the potential of FATE-NK100 to treat patients
with cancer, including as a monotherapy and in combination with
monoclonal antibody therapy for solid tumor malignancies. 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 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 and current
clinical trials of FATE-NK100 may not be replicated in current or
future 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 TartagliaStern
Investor Relations, Inc.212.362.1200christina@sternir.com
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