- Agreement grants Astellas rights to
employ Sangamo's novel proprietary capsid, STAC-BBB, for up to five
potential neurological disease targets -
- Sangamo to receive a $20 million upfront license fee and is eligible
to earn up to $1.3 billion in
additional licensed target fees and milestone payments across all
five potential disease targets, as well as tiered royalties on
potential net sales -
TOKYO and RICHMOND,
Calif., Dec. 19, 2024 /PRNewswire/ -- Astellas
Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Sangamo
Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company,
today announced they have entered into a license agreement allowing
Astellas to leverage Sangamo's novel proprietary neurotropic
adeno-associated virus (AAV) capsid, STAC-BBB, which has
demonstrated potent blood-brain barrier penetration and neuronal
transduction in nonhuman primates. The agreement grants Astellas a
worldwide exclusive license to utilize the STAC-BBB capsid for one
target, with the right to add up to four additional targets after
paying additional licensed target fees to deliver their
intravenously administered genomic medicines to treat certain
neurological diseases.
Sandy Macrae, Chief Executive
Officer, Sangamo
"We strongly believe in the potential of
STAC-BBB, our industry-leading, intravenously delivered AAV capsid,
to overcome the challenges associated with delivering therapies to
the central nervous system. This agreement underscores the
continued industry interest in our STAC-BBB capsid and reinforces
our ongoing commitment to partnering with collaborators who
understand its unique potential. We are delighted to license
STAC-BBB to Astellas to advance potential treatments for
neurological diseases with significant unmet medical needs."
Adam Pearson, Chief Strategy
Officer, Astellas
"Delivering treatments to the brain and
central nervous system remains a highly complex challenge in the
field of gene therapy. We believe that technologies such as
Sangamo's STAC-BBB capsid could prove critical in helping us
deliver effective transformational treatments to patients suffering
from serious genetic neurological conditions. We continue to build
a world-class gene therapy pipeline and end-to-end discovery,
development, manufacturing, and commercial capabilities. This
agreement is another example of our commitment to delivering
meaningful therapies for patients with genetic diseases."
Under the terms of the agreement, Sangamo is responsible for
completing a technology transfer related to the STAC-BBB
capsid. Astellas is responsible for all research, preclinical
and clinical development, regulatory interactions, manufacturing,
and global commercialization of the resulting gene therapy
products. Sangamo will receive a $20
million upfront license fee from Astellas and is eligible to
earn up to $1.3 billion in additional
licensed target fees and milestone payments across the five
potential neurology disease targets, as well as tiered mid-to-high
single digit royalties on potential net sales of such products,
subject to certain specified reductions.
About Astellas
Astellas is a global life sciences company committed to turning
innovative science into VALUE for patients. We provide
transformative therapies in disease areas that include oncology,
ophthalmology, urology, immunology and women's health. Through our
research and development programs, we are pioneering new healthcare
solutions for diseases with high unmet medical need. Learn more at
www.astellas.com.
About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence
developing genetic medicines with the potential to deliver
transformative value for patients. Our gene therapy drug discovery
engine is built around innovative science, a validated AAV
platform, and industry leading internal manufacturing capability
with a particular focus on rare diseases of the eye, CNS and
neuromuscular system. Astellas Gene Therapies will also be
advancing additional Astellas gene therapy programs toward clinical
investigation. Astellas Gene Therapies is based in South San Francisco, with manufacturing and
laboratory facilities in South San
Francisco, Calif., Sanford,
N.C. and Tsukuba, Japan.
About Sangamo Therapeutics
Sangamo Therapeutics is a
genomic medicine company dedicated to translating ground-breaking
science into medicines that transform the lives of patients and
families afflicted with serious neurological diseases who do not
have adequate or any treatment options. Sangamo believes that its
zinc finger epigenetic regulators are ideally suited to potentially
address devastating neurological disorders and that its capsid
discovery platform can expand delivery beyond currently available
intrathecal delivery capsids, including in the central nervous
system. Sangamo's pipeline also includes multiple partnered
programs and programs with opportunities for partnership and
investment. To learn more, visit www.sangamo.com and connect with
us on LinkedIn and Twitter/X.
Astellas Cautionary Notes
In this press release,
statements made with respect to current plans, estimates,
strategies and beliefs and other statements that are not historical
facts are forward-looking statements about the future performance
of Astellas. These statements are based on management's current
assumptions and beliefs in light of the information currently
available to it and involve known and unknown risks and
uncertainties. A number of factors could cause actual results to
differ materially from those discussed in the forward-looking
statements. Such factors include, but are not limited to: (i)
changes in general economic conditions and in laws and regulations,
relating to pharmaceutical markets, (ii) currency exchange rate
fluctuations, (iii) delays in new product launches, (iv) the
inability of Astellas to market existing and new products
effectively, (v) the inability of Astellas to continue to
effectively research and develop products accepted by customers in
highly competitive markets, and (vi) infringements of
Astellas' intellectual property rights by third parties.
Information about pharmaceutical products (including products
currently in development) which is included in this press release
is not intended to constitute an advertisement or medical
advice.
Sangamo Forward Looking Statements
This press release
contains forward-looking statements based on Sangamo's current
expectations. These forward-looking statements include, without
limitation, statements relating to the potential for Astellas to
develop genomic medicines to treat neurodegenerative diseases by
leveraging Sangamo's capsid delivery capabilities, the potential
for intravenously administered STAC-BBB to address challenges in
delivering therapeutics to the central nervous system, the
potential of Sangamo's capsids to deliver therapies treating
neurological diseases, the potential for Astellas to expand its
license to include additional targets and to perform research,
preclinical and clinical development, manufacturing and global
commercialization of licensed gene therapy products for each
licensed target, expectations concerning Sangamo's receipt of an
upfront license fee, the potential for Sangamo to receive
additional licensed target fees, manufacturing, development
and commercial milestone payments, and royalties, and other
statements that are not historical fact. These statements are not
guarantees of future performance and are subject to certain risks
and uncertainties that are difficult to predict. Factors that could
cause actual results to differ include, but are not limited to, the
research and development process, including the results of
preclinical studies and clinical trials; the regulatory approval
process for product candidates; the potential for technological
developments that obviate technologies used by Sangamo and its
partners; the potential for Astellas to breach or terminate its
agreement with Sangamo; and the potential for Sangamo to fail to
realize its expected benefits from the Astellas agreement;
Sangamo's inability to secure additional collaboration partners;
and Sangamo's need for substantial additional funding to operate as
a going concern. There can be no assurance that Sangamo will earn
any milestone or royalty payments under the Astellas agreement or
obtain regulatory approvals for product candidates arising from
this agreement. Actual results may differ from those
projected in forward-looking statements due to risks and
uncertainties that exist in Sangamo's and Astellas's operations and
businesses. These risks and uncertainties are described more fully
in Sangamo's Securities and Exchange Commission, or SEC, filings
and reports, including in its Annual Report on Form 10-K for the
year ended December 31, 2023, as
supplemented by its Quarterly Report on Form 10-Q for the quarter
ended September 30, 2024, each filed
with the SEC, and future filings and reports that Sangamo makes
from time to time with the SEC. Forward-looking statements
contained in this announcement are made as of this date, and
Sangamo undertakes no duty to update such information except as
required under applicable law.
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SOURCE Astellas Pharma Inc.