Sangamo Announces Early Completion of Transfer to Pfizer of SB-525 Hemophilia A Gene Therapy IND & an Earned $25 Million Mile...
December 23 2019 - 6:50AM
Business Wire
- Pfizer advancing SB-525 for Hemophilia A to a
Phase 3 registrational study in 2020
Sangamo Therapeutics, Inc. (Nasdaq: SGMO) announced today the
completion of the transfer to Pfizer of the SB-525 Hemophilia A
gene therapy Investigational New Drug application (IND). Pfizer is
advancing SB-525 into a Phase 3 registrational clinical study in
2020 and has already commenced enrolling patients into a Phase 3
lead-in study. Sangamo has now earned a $25 million milestone
payment, per the terms of a December 2019 amendment to the parties’
collaboration agreement for the global development and
commercialization of gene therapies for Hemophilia A.
“I want to congratulate our team for their success in developing
SB-525 through to this important milestone where we have handed
over the IND to Pfizer for Phase 3 development,” said Sandy Macrae,
CEO of Sangamo. “We are thrilled to be in a partnership where both
parties have cooperated to accelerate study timelines, resulting in
completion of the IND transfer ahead of schedule. Pfizer and
Sangamo are united in our common interest to help patients with
Hemophilia A and will do everything that we can to safely and
expeditiously advance this promising gene therapy candidate for
patients in need.”
The SB-525 collaboration was established in May 2017. Under the
terms of the collaboration agreement, Sangamo has been responsible
for Phase 1/2 clinical development. Pfizer will be operationally
and financially responsible for subsequent research, development,
manufacturing and commercialization activities for SB-525. Sangamo
is eligible to receive total potential milestone payments of up to
$300 million for the development and commercialization of SB-525,
and up to $175 million for additional Hemophilia A gene therapy
product candidates that may be developed under the collaboration.
Sangamo will, additionally, receive tiered royalties starting in
the low teens and up to 20% of annual net sales of SB-525.
About Sangamo Therapeutics
Sangamo Therapeutics is committed to translating ground-breaking
science into genomic medicines with the potential to transform
patients’ lives using gene therapy, ex vivo gene-edited cell
therapy, and in vivo genome editing and gene regulation. For more
information about Sangamo, visit www.sangamo.com.
Sangamo Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of United States
securities law. These forward-looking statements include, but are
not limited to, the therapeutic potential of SB-525; the enrollment
of clinical trials and global registration and commercialization
and the expected timing for milestones the expected benefits of
Sangamo’s collaboration with Pfizer; the anticipated capabilities
of Sangamo’s technologies; and other statements that are not
historical fact. These statements are based upon Sangamo’s current
expectations and speak only as of the date hereof. Sangamo’s actual
results may differ materially and adversely from those expressed in
any forward-looking statements. Factors that could cause actual
results to differ include, but are not limited to, risks and
uncertainties related to dependence on the success of clinical
trials; the uncertain regulatory approval process; the costly
research and development process, including the uncertain timing of
clinical trials; whether interim, preliminary or initial data from
ongoing clinical trials will be representative of the final results
from such clinical trials; whether the final results from ongoing
clinical trials will validate and support the safety and efficacy
of product candidates; the risk that clinical trial data are
subject to differing interpretations by regulatory authorities; the
potential inability of Sangamo and its partners to advance product
candidates into registrational studies; Sangamo’s reliance on
itself, partners and other third-parties to meet clinical and
manufacturing obligations; Sangamo’s ability to maintain strategic
partnerships; competing drugs and product candidates that may be
superior to Sangamo’s product candidates; and the potential for
technological developments by Sangamo's competitors that will
obviate Sangamo's gene therapy technology. Actual results may
differ from those projected in forward-looking statements due to
risks and uncertainties that exist in Sangamo’s operations. These
risks and uncertainties are described more fully in Sangamo's
Annual Report on Form 10-K for the year ended December 31, 2018 as
filed with the Securities and Exchange Commission on March 1, 2019
and Sangamo's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2019 that it filed on or about November 6, 2019.
Except as required by law, we assume no obligation, and we disclaim
any intent, to update these statements to reflect actual
results.
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version on businesswire.com: https://www.businesswire.com/news/home/20191223005185/en/
Media and Investor Relations – Global McDavid Stilwell
510-970-6000, x219 mstilwell@sangamo.com
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