Fate Therapeutics and Regents of the University of Minnesota Expand Research Collaboration for Clinical Translation of Engine...
February 27 2017 - 8:00AM
Off-the-Shelf Natural Killer Cell Therapy Being
Developed to Complement Standard-of-Care Monoclonal Antibody
Treatment for Cancer
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 an expansion of its research
collaboration with the Regents of the University of Minnesota (UMN)
to initiate the clinical translation of a first-of-kind product
candidate, an off-the-shelf targeted natural killer (NK) cell
cancer immunotherapy derived from an engineered induced pluripotent
stem cell (iPSC) line.
The Company plans to produce the product candidate from a single
iPSC that is first genetically engineered to express a
high-affinity, non-cleavable CD16 (hnCD16) receptor and then is
clonally-expanded to generate a master engineered pluripotent cell
line. Similar to master cell lines used for the manufacture of
therapeutic antibodies, a master engineered pluripotent cell line
can be used to repeatedly create clonal populations of effector
cells to enable off-the-shelf treatment of many thousands of
patients. Preclinical production runs have shown that a single iPSC
can yield a homogeneous population of over one million iPSC-derived
NK (iNK) cells.
“Using induced pluripotent stem cells, which possess the unique
dual properties of unlimited self-renewal and differentiation
potential into all cell types of the body, is a first-of-kind
approach that enables tremendous product development optionality
for the Company. Our first announced iPSC-derived cell product
candidate, a natural killer cell incorporating CD16 as the
targeting element, is derived from a master pluripotent cell line.
This line serves as the backbone into which we have engineered
other targeting and functional elements, such as chimeric antigen
receptors, and from which we can derive effector cells including NK
and T cells,” said Scott Wolchko, President and Chief Executive
Officer of Fate Therapeutics. “We look forward to working closely
with the FDA and regulatory authorities in other territories in
2017 to advance our revolutionary approach for off-the-shelf
cellular immunotherapy into clinical development.”
NK cells have been proven to play a major role in cancer
immunotherapy including antibody-dependent cellular cytotoxicity
(ADCC), which involves targeting of tumor cells by monoclonal
antibodies for the treatment of breast, head and neck, colorectal
and certain blood cancers. Activation of NK cells through CD16, a
receptor that can bind to antibody-coated tumor cells, unleashes
potent NK cell-mediated anti-tumor responses including direct lysis
of target cells and cytokine secretion for adaptive immune cell
recruitment. The Company’s hnCD16 receptor, which is licensed
exclusively from UMN, incorporates two unique modifications
designed to enhance the anti-tumor activity of NK cells. The
receptor has been modified to augment its binding affinity to
certain monoclonal antibodies, and also to prevent its shedding
from the surface of NK cells upon activation which can otherwise
diminish effector function.
In preclinical studies, the Company has shown that its
hnCD16-iNK cell product candidate exhibits potent and persistent
anti-tumor activity in vitro and in vivo in multiple tumor cell
recognition and killing assays:
- hnCD16-iNK cells exhibit superior ADCC when combined with
cetuximab, as compared to conventional NK cells sourced from
peripheral blood and cord blood, in an in vitro killing assay of a
human ovarian cancer cell line that is positive for EGFR
expression;
- hnCD16-iNK cells show a dose-dependent killing response in
combination with rituximab in vitro in a CD20+ human
lymphoblast-derived B-lymphocyte cell line killing assay; and
- hnCD16-iNK cells augment anti-tumor activity in combination
with trastuzumab in vivo, as compared to mice treated with
trastuzumab alone, in a HER2+ ovarian cancer model, where the
anti-tumor effect at Week 6 of hnCD16-iNK plus trastuzumab was
durable with no tumor detectable by imaging in 80% of the mice as
compared to trastuzumab alone where all mice displayed tumor
burden.
The collaboration is being led by renowned NK cell biologist
Jeffrey S. Miller, M.D., Deputy Director of the Masonic Cancer
Center, University of Minnesota. The Company has exclusively
licensed from UMN foundational intellectual property covering
compositions of a modified CD16 as well as certain chimeric antigen
receptors and of immune cells expressing such receptors, and also
maintains an option to exclusively license all intellectual
property arising from research and development activities under the
collaboration.
In addition to its collaboration with UMN, Fate Therapeutics has
also partnered with Memorial Sloan Kettering Cancer Center for the
development of off-the-shelf T-cell product candidates using
engineered iPSCs. Research and development activities are being led
by Michel Sadelain, M.D., Ph.D., Director of the Center for Cell
Engineering and the Stephen and Barbara Friedman Chair at Memorial
Sloan Kettering Cancer Center.
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 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 StatementsThis release contains
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
regarding the impact, benefits, timing, and conduct of the
partnership between the Company and UMN, as well as the
capabilities, expertise, and responsibilities of each, and the
therapeutic potential of any cellular immunotherapies developed
under the partnership. 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, risks associated with the success, cost,
and timing of research and product development activities under the
collaboration, the risk of cessation or delay of any development
activities under the collaboration for a variety of reasons,
including any inability to develop or manufacture off-the-shelf NK
cell products, and the risk that any off-the-shelf NK cell
therapies developed under the collaboration may not be suitable for
therapeutic applications and may not provide the anticipated
therapeutic benefits. 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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