Fate Therapeutics to Present Preclinical Data for ProTmune™ at 2016 BMT Tandem Meetings
February 21 2016 - 8:01AM
Poster Presentation to Highlight Anti-Tumor
Properties of Ex Vivo Programmed Donor T Cells
Fate Therapeutics, Inc. (NASDAQ:FATE), a biopharmaceutical company
dedicated to the development of programmed cellular immunotherapies
for cancer and immune disorders, announced today that it will
present preclinical anti-tumor data for ProTmune™, its lead product
candidate for the prevention of acute graft-versus-host-disease
(GvHD) and cytomegalovirus (CMV) infection in patients undergoing
mobilized peripheral blood (mPB) hematopoietic cell transplantation
(HCT), at the BMT Tandem Meetings in Honolulu, Hawaii. The
Company's investigational new drug application for ProTmune was
cleared by the U.S. Food and Drug Administration in January 2016,
and Fate Therapeutics plans to initiate enrollment of a
multi-center, randomized, controlled Phase 1/2 clinical trial in
adult patients with hematologic malignancies in mid-2016.
“Acute GvHD is a leading cause of morbidity and mortality in
immunocompromised patients undergoing allogeneic HCT. Therapeutic
strategies aimed at addressing GvHD, including the use of systemic
agents that suppress or deplete the immune system, can compromise
or eliminate T cells, often leading to severe infections and
disease relapse,” said Scott Wolchko, President and Chief Executive
Officer of Fate Therapeutics. “These encouraging new preclinical
data, which demonstrate that the cancer-fighting properties of ex
vivo programmed donor T cells are maintained following adoptive
transfer, continue to underscore the multi-dimensional therapeutic
value proposition that we aim to deliver to HCT patients with
ProTmune.”
ProTmune is a programmed cellular immunotherapy undergoing
clinical development for use as an allogeneic hematopoietic cell
source for HCT. The cell therapy is produced by modulating mPB with
two small molecules (FT1050 and FT4145) ex vivo to enhance the
biological properties and therapeutic function of immune cells, and
the resulting programmed mPB cells are adoptively transferred to a
patient through a single administration. Fate Therapeutics plans to
initiate enrollment in mid-2016 of a Phase 1/2 clinical trial of
ProTmune to evaluate safety and tolerability and to assess its
potential to prevent acute GvHD and CMV infection.
Since the anti-tumor, or graft-versus-leukemia (GvL), activity
of donor T cells is a major component of the overall beneficial
effects of allogeneic HCT for hematologic malignancies, scientists
at Fate Therapeutics defined the impact of FT1050-FT4145 modulation
on the anti-tumor effector properties of donor T cells in a murine
model of leukemia. New preclinical data being presented today
demonstrate that ex vivo programmed donor T cells retain GvL
activity, which is critical to eradicating residual cancer and
realizing the curative potential of allogeneic HCT. In December
2015, the Company presented data at the American Society of
Hematology 2015 Annual Meeting demonstrating that the adoptive
transfer of FT1050-FT4145 programmed mPB cells results in a
statistically-significant reduction in GvHD score and improvement
in survival in a murine model of allogeneic HCT, as compared to
vehicle-treated cells. Taken together, these preclinical data
suggest that ex vivo small molecule programming of donor immune
cells is a highly-differentiated therapeutic strategy to suppress
the GvHD response and maintain the GvL activity of donor T cells.
The full data presentation will be held today at 6:45 p.m. HST
(11:45 p.m. EST) at the Hawaii Convention Center in Honolulu,
Hawaii.
According to the Center for International Blood and Marrow
Transplant Research, there are approximately 30,000 allogeneic HCT
procedures performed globally each year, of which approximately 65%
utilize mPB as the donor cell source. GvHD and severe infections
are life-threatening complications that significantly impair the
quality of life and that often compromise the curative potential of
HCT, with 35-50% of patients developing acute GvHD and 70-80% of
patients experiencing at least one severe infection. There are
currently no approved therapies for the prevention of GvHD or CMV
infection in patients undergoing allogeneic HCT, giving rise to a
significant unmet medical need.
About Fate Therapeutics, Inc.
Fate Therapeutics is a biopharmaceutical company dedicated to
the development of programmed cellular immunotherapies for cancer
and immune disorders. The Company’s cell-based product pipeline is
comprised of off-the-shelf immuno-oncology therapies, including NK-
and T-cell-based candidates derived from induced pluripotent cells,
and immuno-regulatory therapies, including hematopoietic cell-based
candidates for protecting the immune system of patients undergoing
hematopoietic cell transplantation and for suppressing
autoimmunity. Its adoptive cell therapy candidates 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 Company’s intention to initiate
a clinical trial for ProTmune during 2016, the therapeutic
potential of ProTmune, and the Company’s plans and ability to
develop programmed cellular immunotherapies, including ProTmune.
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 adverse events or other
results that may be observed during development), any inability to
develop programmed cellular immunotherapies which are suitable for
therapeutic applications, the risk that results observed in prior
preclinical studies of ProTmune may not be replicated in subsequent
studies or clinical trials, and the risk that ProTmune or
programmed cellular immunotherapies that the Company may develop
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 the Company’s 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
Form 10-Q for the quarter ended September 30, 2015, and from time
to time the Company’s other investor communications. The
Company 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.
Jesse Baumgartner
Stern Investor Relations, Inc.
212.362.1200
jesse@sternir.com
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