Allogene Therapeutics and Notch Therapeutics Announce Collaboration to Research and Develop Induced Pluripotent Stem Cell (iP...
November 05 2019 - 6:28AM
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) therapies for cancer, and Notch Therapeutics Inc.,
an immune cell therapy company creating universally compatible,
allogeneic T cell therapies for the treatment of diseases of high
unmet need, today announced an exclusive worldwide collaboration
and license agreement to research and develop induced pluripotent
stem cell (iPSC) AlloCAR™ therapy products for initial application
in non-Hodgkin lymphoma, leukemia and multiple myeloma. Under the
partnership, Allogene and Notch will create allogeneic cell therapy
candidates from T cells or natural killer (NK) cells using Notch’s
Engineered Thymic Niche (ETN) platform. Notch was established in
2018 by Juan Carlos Zúñiga-Pflücker, Ph.D. and Peter Zandstra,
Ph.D., recognized pioneers in iPSC and T cell differentiation
technology. Notch is developing a next-generation approach to
differentiating mature immune cells from iPSCs. The Notch ETN
technology platform offers potential flexibility and scalability
for the production of stem cell-derived immune cell therapies.
iPSCs may provide renewable starting material for AlloCAR T
therapies that could allow for improved efficiency of gene editing,
greater scalability of supply, product homogeneity and more
streamlined manufacturing.
“This collaboration exemplifies Allogene’s long-term commitment
to advancing the field of cancer treatment as we continue to expand
and progress our innovative pipeline of off-the-shelf AlloCAR
candidates,” said David Chang, M.D., Ph.D., President, CEO and
Co-Founder of Allogene Therapeutics. “The scientific founders of
Notch Therapeutics are among the most respected experts in the
field of stem cell biology and its applications to generating T
cells and other functional immune cells. We are confident that
their technology and expertise, combined with Allogene’s leadership
in AlloCAR therapies, has the potential to unlock future
generations of cell therapy treatments for patients.”
“Renewable-source, off-the-shelf cell therapies that may produce
cells with greater consistency and at industrial scale have long
been the dream for people working in this field,” said Ulrik
Nielsen, Ph.D., Executive Chairman of Notch. “We are delighted to
spring into the research collaboration for iPSC-based AlloCAR
therapies with Allogene, a leader in the allogeneic CAR T field,
with the goal of expanding options for patients.”
Under the terms of the agreement, Notch will be responsible for
preclinical research of next-generation iPSC AlloCAR T™ cells.
Allogene will clinically develop the product candidates and holds
exclusive worldwide rights to commercialize resulting products.
Allogene will provide to Notch an upfront payment of $10 million.
Notch will be eligible to receive up to $7.25 million upon
achieving certain agreed research milestones, up to $4.0 million
per exclusive target upon achieving certain pre-clinical
development milestones, and up to $283 million per exclusive target
and cell type upon achieving certain clinical, regulatory and
commercial milestones as well as tiered royalties on net sales in
the mid to high single digits. In addition to this collaboration
and license agreement, Allogene has acquired a 25 percent equity
position in Notch and will assume a seat on Notch’s Board of
Directors. “Master cell banks of genetically modified, induced
pluripotent stem cells could provide an inexhaustible source of
cell therapies that may improve outcomes and expand applicability
to new areas,” said Notch Co-Founder Juan Carlos Zúñiga-Pflücker,
Ph.D., a senior scientist at Sunnybrook Research Institute and a
Professor and Chair of the Department of Immunology at the
University of Toronto.
“This work with Allogene may also pave the way for additional
off-the-shelf cell therapeutics that are custom-designed to treat
other immunity-related diseases such as infectious diseases,
autoimmune diseases and aging,” said Notch Co-Founder and Chief
Scientific Officer Peter Zandstra, Ph.D., a Professor at the
University of British Columbia and University of Toronto.
About Notch Therapeutics (www.notchtx.com)Notch
is an immune cell therapy company creating universally compatible,
allogeneic (off-the-shelf) T cell therapies for the treatment of
diseases of high unmet medical need. Notch’s technology platform
uses genetically tailored stem cells as a renewable source for
creating allogeneic T cell therapies that expand treatment options
and deliver safer, consistently manufactured and more
cost-effective cell immunotherapies to patients. At the core of
Notch’s technology is the synthetic Engineered Thymic Niche (ETN)
platform, which drives the expansion and differentiation of stem
cells in scalable, fully defined, feeder-free and serum-free
cultures into T cells that can be genetically tailored for any T
cell-based immunotherapeutic application. This technology was
invented in the laboratories of Juan-Carlos Zúñiga-Pflücker, Ph.D.
at Sunnybrook Research Institute and Peter Zandstra, Ph.D., FRSC at
the University of Toronto. Notch was founded by these two
institutions, in conjunction with MaRS Innovation (now Toronto
Innovation Acceleration Partners) and the Center for
Commercialization of Regenerative Medicine (CCRM) in Toronto.
About Allogene Therapeutics Allogene
Therapeutics, with headquarters in South San Francisco, is a
clinical-stage biotechnology company pioneering the development of
allogeneic chimeric antigen receptor T cell (AlloCAR T™)
therapies for cancer. Led by a world-class management team with
significant experience in cell therapy, Allogene is developing
a pipeline of “off-the-shelf” CAR T cell therapy candidates
with the goal of delivering readily available cell therapy
on-demand, more reliably, and at greater scale to more
patients. For more information, please visit www.allogene.com,
and follow @AllogeneTx on Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes
of the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. The press release may, in some cases, use terms
such as "predicts," "believes," "potential," "proposed,"
"continue," "estimates," "anticipates," "expects," "plans,"
"intends," "may," "could," "might," "will," "should" or other words
that convey uncertainty of future events or outcomes to identify
these forward-looking statements. Forward-looking statements
include statements regarding intentions, beliefs, projections,
outlook, analyses or current expectations concerning, among other
things: the ability to progress the research collaboration, Notch’s
ability to develop a next-generation approach to differentiating
mature immune cells from iPSCs, the ability to develop and
manufacture new therapies from Notch technology, and the potential
benefits of Notch technology and AlloCAR T therapy. Various factors
may cause differences between Allogene’s expectations and actual
results as discussed in greater detail in Allogene’s filings with
the Securities and Exchange Commission (SEC), including
without limitation in its Form 10-Q for the quarter ended June
30, 2019. Any forward-looking statements that are made in this
press release speak only as of the date of this press release.
Allogene assumes no obligation to update the forward-looking
statements whether as a result of new information, future events or
otherwise, after the date of this press release.
Allogene Media/Investor Contact:Christine
CassianoChief Communications Officer(714)
552-0326Christine.Cassiano@allogene.com
Notch Media Contact:Mary MoynihanM2Friend
Biocommunications802-951-9600mary@m2friend.com
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