Fate Therapeutics Announces Initial Clinical Data from Ongoing First-in-Human VOYAGE Study of FATE-NK100 for Relapsed / Refra...
November 10 2017 - 8:00AM
Subject
in Dose Cohort 2 Achieves Morphologic Leukemia-free State at Day
14
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
VOYAGE Phase 1 study of FATE-NK100 as a monotherapy for the
treatment of refractory or relapsed acute myelogenous leukemia
(AML). The data were presented today in a poster session at the
Society for Immunotherapy of Cancer (SITC) 2017 Annual Meeting in
National Harbor, Maryland.
Anti-leukemia activity was observed with FATE-NK100, the
Company’s first-in-class adaptive memory natural killer (NK) cell
cancer immunotherapy, in each of the treated dose cohorts of the
VOYAGE study. The subject in the second dose cohort (2x107
cells/kg) achieved a morphologic leukemia-free state (mLFS)
following a single intravenous infusion of FATE-NK100 as a
monotherapy. Prior to treatment, the subject presented in relapse,
was refractory to conventional NK cell therapy and had 50% leukemic
blasts in the bone marrow. At Day 14 following treatment, a bone
marrow biopsy showed clearance of leukemic blasts in the marrow,
and approximately 3x104 FATE-NK100 cells per mL were measured in
the peripheral blood.
“These are encouraging early data for FATE-NK100 in refractory
and relapsed AML, especially in patients with such high leukemic
blast burden in the marrow that have exhausted all therapeutic
options,” 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.
“The disappearance of all cells with morphologic characteristics of
leukemia validates the in vivo anti-leukemia activity of
FATE-NK100. We look forward to continuing enrollment in the VOYAGE
study and to dosing the first patient with FATE-NK100 in the APOLLO
study for the treatment of women with recurrent ovarian
cancer.”
The subject in the first dose cohort of VOYAGE (1x107 cells/kg)
presented in primary induction failure with 87% leukemic blasts in
the bone marrow. Two weeks following a single infusion of
FATE-NK100, a bone marrow biopsy revealed a nearly 50% reduction in
leukemic blasts. In addition, approximately 76% of NK cells in the
peripheral blood were of FATE-NK100 origin.
“The significant reduction of leukemic blasts in the bone marrow
observed in both subjects without any dose-limiting toxicities is
very promising,” stated Scott Wolchko, Chief Executive Officer of
Fate Therapeutics. “Although the second subject’s morphologic
leukemia-free state was not sustained following a single dose of
FATE-NK100, the clearance of leukemia at Day 14 coupled with the
presence of FATE-NK100 in circulation validates the cell product’s
enhanced potency and persistence. We look forward to
continuing subject enrollment and to combining FATE-NK100 with
monoclonal antibody therapy for the treatment of advanced solid
tumors through the launch of our DIMENSION study.”
The accelerated dose-escalation design of VOYAGE is designed to
evaluate the safety and determine the maximum dose of a single
intravenous infusion of FATE-NK100 as a monotherapy. The three dose
levels are 1x107, 2x107 and up to 1x108 adjusted to kg of body
weight. FATE-NK100 has now advanced through the first two dose
cohorts with no reports of dose limiting toxicities (DLTs). The
third dose cohort is currently enrolling. A ten-subject expansion
cohort is expected to be enrolled at the maximum dose level.
About FATE-NK100FATE-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 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 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 donor are activated ex vivo with
pharmacologic modulators.
About VOYAGEVOYAGE is an open-label,
accelerated dose-escalation, Phase 1 clinical trial designed to
evaluate the safety and determine the maximum dose of a single
intravenous infusion of FATE-NK100 as a monotherapy administered
after lymphodepleting chemotherapy followed by sub-cutaneous IL-2
administration in subjects with refractory or relapsed acute
myelogenous leukemia (AML). One subject is being enrolled in each
of the three planned dose cohorts. A ten-subject expansion cohort
is expected to be enrolled at the maximum dose level. Anti-tumor
activity of FATE-NK100 is being assessed by rates of complete
response, disease-free survival and overall survival. The study is
being conducted at the Masonic Cancer Center, University of
Minnesota as an investigator-initiated study.
Acute Myelogenous LeukemiaAcute myelogenous
leukemia (AML) is an aggressive cancer of the blood and bone marrow
that progresses rapidly without treatment. Cancerous cells called
leukemic blasts multiply and displace normal cells in the bone
marrow, disrupting normal blood cell production. Each year in the
United States, about 19,900 people are diagnosed with AML, and
about 10,400 people die from all forms of the disease, according to
the American Cancer Society. Current treatment options for AML
consist of reducing and eliminating cancer cells mainly through
chemotherapy, radiation therapy, and stem cell transplantation.
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 expected clinical development plans
for 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 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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