Fate Therapeutics Announces Initial Clinical Data of FATE-NK100 for Recurrent Ovarian Cancer at the Innate Killer Summit 2018...
March 29 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 initial clinical data from the ongoing
APOLLO Phase 1 study of FATE-NK100 as a monotherapy following
outpatient chemotherapy for the treatment of women with ovarian
cancer resistant to, or recurrent on, platinum-based treatment. No
dose-limiting toxicities were reported in either of the two
subjects receiving NK100, the Company’s first-in-class,
donor-derived adaptive memory natural killer (NK) cell cancer
immunotherapy. Additionally, the Day 28 response evaluation for
Subject 2 following a single intraperitoneal infusion of NK100
showed stable disease with evidence of tumor reduction.
“We are very encouraged by our initial clinical observations of
FATE-NK100 in heavily pre-treated patients with recurrent ovarian
cancer,” said Melissa Geller M.D., Associate Professor of
Gynecologic Oncology, Department of Obstetrics, Gynecology and
Women’s Health at the University of Minnesota and Principal
Investigator of the APOLLO clinical trial at the Masonic Cancer
Center. “Currently approved single-agent therapies for
platinum-resistant ovarian cancer typically have low response rates
and short median progression-free survival. The administration of
NK100 directly within the peritoneal cavity is a novel therapeutic
strategy to potentially improve these dismal outcomes.”
Subject 2 enrolled with platinum-resistant stage III fallopian
tube carcinoma having been treated with five prior lines of therapy
and most recently progressing following three cycles of Avastin®
(bevacizumab) plus Cytoxan® (cyclophosphamide) and 12 cycles of
Zejula® (niraparib). Stable disease with evidence of tumor
reduction was observed at Day 28 following a single intraperitoneal
infusion of NK100 (2x107 cells/kg). The subject elected to receive
a second infusion of NK100. Both doses were well-tolerated and
persistence of each dose was observed in the intraperitoneal cavity
at two weeks following infusion.
The data were featured in an oral presentation by Jeffrey S.
Miller, M.D., Professor of Medicine, Deputy Director of the Masonic
Cancer Center, University of Minnesota at the Innate Killer Summit
2018 being held in San Diego, CA, March 28-29, 2018.
“We continue to be impressed with the safety profile and
enhanced persistence of FATE-NK100. These data in ovarian cancer
reinforce our experience with NK100 in the VOYAGE study for
relapsed refractory AML and strengthen our conviction that NK100 is
capable of addressing a broad range of tumors, including those that
are known to be unresponsive to current immunotherapies,” said Dr.
Miller.
Longer-term follow-up assessments of response are pending for
Subject 2. Subject 1 enrolled at the first dose level (1x107
cells/kg) with platinum-resistant ovarian cancer having failed five
prior lines of therapy, and showed progressive disease at Day 28
follow-up. APOLLO is currently enrolling at the third dose level
(≥3x107 cells/kg to 1x108 cells/kg). Ten subjects are expected to
be enrolled at the maximum dose level.
About Ovarian CancerOvarian cancer is the
fifth leading cause of cancer-related death among women and is
the deadliest of gynecologic cancers. The American Cancer
Society estimates that in 2017, about 22,440 new cases
of ovarian cancer will be diagnosed and 14,080 women will die
of ovarian cancer in the United States. While a high
proportion of women respond to initial platinum-based chemotherapy,
around 70% of patients diagnosed with ovarian cancer will have a
recurrence. While recurrent ovarian cancer is treatable, it is
rarely curable and there is a significant need for more effective,
better-tolerated therapies.
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 seven-day, feeder-free manufacturing process
during which NK cells sourced from a healthy 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 APOLLOAPOLLO is an ongoing open-label,
accelerated dose-escalation, Phase 1 clinical trial of FATE-NK100
in women with ovarian, fallopian tube or primary peritoneal cancer
resistant to, or recurrent on, platinum-based treatment. The
primary objective of the clinical trial is to assess the safety and
determine the maximum dose of a single infusion via intraperitoneal
catheter of FATE-NK100 as a monotherapy when administered after
outpatient chemotherapy followed by a short course of
intraperitoneal IL-2 infusion. Up to three dose levels of
FATE-NK100 are intended to be assessed, proceeding in cohorts of
one subject per dose level until a dose-limiting toxicity is
observed. A total of ten subjects are expected to be enrolled at
the maximum dose level. Other endpoints include objective response
rates at 28 days and progression-free and overall survival at six
months. The clinical trial is being conducted at the Masonic Cancer
Center, University of Minnesota as an investigator-initiated
study.
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
consistently and repeatedly manufacturing 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 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.
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 hematologic and solid tumor malignancies, including relapsed
refractory acute myeloid leukemia (AML) and recurrent ovarian
cancer. 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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