Scholar Rock Achieves First Milestone in Strategic Fibrosis Collaboration with Gilead Sciences
January 09 2020 - 6:30AM
Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical
company focused on the treatment of serious diseases in which
protein growth factors play a fundamental role, today announced
that the Company has earned a $25 million milestone payment from
Gilead Sciences, Inc. (NASDAQ: GILD) for the successful
demonstration of efficacy in preclinical in vivo proof-of-concept
studies. This is the most advanced program of the collaboration
focused on the discovery and development of potent and selective
inhibitors of latent transforming growth factor beta (TGFβ)
activation for the treatment of fibrotic diseases.
“Achieving this important first milestone at the one year mark
of the collaboration is indicative of the progress we are making
together towards unlocking the potential of this novel approach to
TGFβ inhibition in the treatment of patients suffering from
fibrotic diseases,” said Nagesh Mahanthappa, Ph.D., President and
CEO of Scholar Rock. “This accomplishment further validates the
broad applicability of our platform by targeting the activation of
latent growth factors to overcome historic challenges with
selectivity and to discover and develop safe and effective
therapeutics to address a wide range of serious diseases, including
neuromuscular disorders, cancers, fibrosis, and anemia.”
The collaboration between Gilead and Scholar Rock was
established in December 2018 to discover and develop therapeutics
that target TGFβ-driven signaling, a central regulator of fibrosis.
Scholar Rock retains exclusive worldwide rights to discover,
develop, and commercialize certain TGFβ inhibitors for oncology and
cancer immunotherapy.
Scholar Rock received $80 million in upfront payments in
connection with the collaboration, comprised of $50 million cash
and $30 million purchase of Scholar Rock Holding Corporation common
stock. In addition to this one-time $25 million preclinical
milestone, Scholar Rock is eligible to receive up to an additional
$1,425 million in potential payments from Gilead aggregated across
all three programs based on the successful achievement of certain
research, development, regulatory and commercialization milestones.
Scholar Rock would also receive high single-digit to low
double-digit tiered royalties on sales of potential future products
originating from the collaboration.
Under the collaboration, Gilead has exclusive options to license
worldwide rights to product candidates that emerge from three
Scholar Rock TGFβ programs: inhibitors that target activation of
latent TGFβ1 with high affinity and specificity, inhibitors that
selectively target activation of latent TGFβ1 localized to
extracellular matrix, and a third TGFβ discovery program. Scholar
Rock is responsible for antibody discovery and preclinical research
through product candidate nomination, after which, upon exercising
the option for a program, Gilead will be responsible for the
program’s preclinical and clinical development and
commercialization.
About Scholar Rock Scholar Rock is a
clinical-stage biopharmaceutical company focused on the discovery
and development of innovative medicines for the treatment of
serious diseases in which signaling by protein growth factors plays
a fundamental role. Scholar Rock is creating a pipeline of novel
product candidates with the potential to transform the lives of
patients suffering from a wide range of serious diseases, including
neuromuscular disorders, cancer, fibrosis and anemia. The Company’s
two lead product candidates include SRK-015, a selective inhibitor
of the activation of myostatin, for the treatment of patients with
Spinal Muscular Atrophy and SRK-181, an isoform-selective inhibitor
of TGFβ1 activation as a cancer immunotherapy in combination with
anti-PD(L)1 antibodies. Scholar Rock’s newly elucidated
understanding of the molecular mechanisms of growth factor
activation enabled it to develop a proprietary platform for the
discovery and development of monoclonal antibodies that locally and
selectively target these signaling proteins at the cellular level.
By developing product candidates that act in the disease
microenvironment, the Company intends to avoid the historical
challenges associated with inhibiting growth factors for
therapeutic effect. Scholar Rock believes its focus on biologically
validated growth factors may facilitate a more efficient
development path.
For more information, please visit www.ScholarRock.com or
follow Scholar Rock on Twitter @ScholarRock and LinkedIn.
Scholar Rock® is a registered trademark of Scholar Rock,
Inc.
Forward-Looking StatementThis press release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including, but
not limited to, statements regarding Scholar Rock’s future
expectations, plans and prospects, including without limitation,
expectations regarding the potential of Scholar Rock’s platform,
TGFβ programs and molecules and progress made under Scholar Rock’s
collaboration with Gilead. The use of words such as “may,” “might,”
“will,” “should,” “expect,” “plan,” “anticipate,” “believe,”
“estimate,” “project,” “intend,” “future,” “potential,” or
“continue,” and other similar expressions are intended to identify
such forward-looking statements. All such forward-looking
statements 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 the risks that preclinical
data and results may not be predictive of clinical results or the
success of Scholar Rock’s platform or of Scholar Rock’s
collaboration with Gilead and those risks more fully discussed in
the section entitled "Risk Factors" in Scholar Rock’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2019, as
well as discussions of potential risks, uncertainties, and other
important factors in Scholar Rock’s subsequent filings with the
Securities and Exchange Commission. Any forward-looking statements
represent Scholar Rock’s views only as of today and should not be
relied upon as representing its views as of any subsequent date.
All information in this press release is as of the date of the
release, and Scholar Rock undertakes no duty to update this
information unless required by law.
Contacts Investors/Media: Catherine Hu
chu@scholarrock.com +1 917-601-1649
Media:Kathryn MorrisKathryn@theyatesnetwork.com +1
914-204-6412
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