Scholar Rock Announces Issuance of U.S. Patent Protecting SRK-181, an Inhibitor of TGFβ1 Activation
September 28 2021 - 4:01PM
Business Wire
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 United States Patent and Trademark Office (USPTO) issued
U.S. Patent No. 11,130,803, with an expiry of May 2040, including
313 days of Patent Term Adjustment (PTA). This US patent includes
composition-of-matter claims, providing product protection for
SRK-181, a selective inhibitor of TGFβ1 activation that avoids
binding to latent TGFβ2, latent TGFβ3, or any of the three active
TGFβ growth factors. SRK-181 is an investigational clinical
candidate being developed to overcome primary resistance to and
increase the number of patients who could benefit from checkpoint
inhibitors, such as anti-PD-(L)1 therapies.
“This is another important addition to our patent portfolio
providing product protection for SRK-181 as we continue to progress
the DRAGON Phase 1 trial in patients with locally advanced or
metastatic solid tumors,” said Nagesh Mahanthappa, Ph.D., Interim
CEO of Scholar Rock. “As we observed in preclinical studies, our
hypothesis remains that a selective approach to targeting the TGFβ1
isoform could allow for an improved safety and efficacy profile
compared to non-selective approaches and we’re very excited to
continue pursuing our unique approach to provide potential clinical
benefit for patients who are resistant to treatment with PD-(L)1
inhibitors.”
SRK-181 is being evaluated in the two-part DRAGON trial
(NCT04291079) in patients with locally advanced or metastatic solid
tumors exhibiting primary resistance to anti-PD-(L)1 therapy. Part
A dose escalation is evaluating the safety and pharmacokinetics of
SRK-181 as a single-agent and in combination with anti-PD-(L)1
therapy to identify the recommended dose for Part B of the trial.
Part B dose expansion will consist of multiple cohorts, including
urothelial carcinoma, cutaneous melanoma, non-small cell lung
cancer, and other solid tumors and patients will be treated with
SRK-181 in combination with an anti-PD-(L)1 therapy. An update on
dose escalation and initial clinical data from Part A of the DRAGON
trial is anticipated by year-end.
About SRK-181
SRK-181 is a selective inhibitor of TGFβ1 activation and is an
investigational product candidate being developed to overcome
primary resistance to checkpoint inhibitor therapy, such as
anti-PD-(L)1 antibodies. TGFβ1 is the predominant TGFβ isoform
expressed in many human tumor types. Based on analyses of various
human tumors that are resistant to anti-PD-(L)1 therapy, data
suggest TGFβ1 is a key contributor to the immunosuppressive tumor
microenvironment, excluding and preventing entry of cytotoxic T
cells into the tumor, thereby inhibiting anti-tumor immunity (1).
Scholar Rock believes SRK-181, which specifically targets the
latent TGFβ1 isoform, has the potential to overcome this immune
cell exclusion and induce tumor regression when administered in
combination with anti-PD-(L)1 therapy while potentially avoiding
toxicities associated with non-selective TGFβ inhibition. The
DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) in
patients with locally advanced or metastatic solid tumors is
ongoing. The efficacy and safety of SRK-181 have not been
established. SRK-181 has not been approved for any use by the FDA
nor any other regulatory agency.
(1) Martin et al., Sci. Transl. Med. 12: 25 March 2020
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. Scholar Rock’s approach to targeting 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 https://scholarrock.com/ or follow Scholar Rock on
Twitter (@ScholarRock) and LinkedIn
(https://www.linkedin.com/company/scholar-rock/).
Scholar Rock® is a registered trademark of Scholar Rock,
Inc.
Forward-Looking Statements
This 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, Scholar Rock’s expectations regarding its growth,
strategy, progress and timing of its clinical trials for
apitegromab, SRK-181, and other product candidates and indication
selection and development timing, its cash runway, the ability of
any product candidate to perform in humans in a manner consistent
with earlier nonclinical, preclinical or clinical trial data, and
the potential of its product candidates and proprietary platform.
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 preclinical and clinical data, including the
12-month top-line results from the Phase 2 trial of apitegromab,
are not predictive of, are inconsistent with, or more favorable
than, data generated from future clinical trials of the same
product candidate, including the planned Phase 3 trial of
apitegromab in SMA, Scholar Rock’s ability to provide the financial
support, resources and expertise necessary to identify and develop
product candidates on the expected timeline, the data generated
from Scholar Rock’s nonclinical and preclinical studies and
clinical trials, information provided or decisions made by
regulatory authorities, competition from third parties that are
developing products for similar uses, Scholar Rock’s ability to
obtain, maintain and protect its intellectual property, the success
of Scholar Rock’s current and potential future collaborations,
including its collaboration with Gilead, Scholar Rock’s dependence
on third parties for development and manufacture of product
candidates including to supply any clinical trials, Scholar Rock’s
ability to manage expenses and to obtain additional funding when
needed to support its business activities and establish and
maintain strategic business alliances and new business initiatives,
and the impacts of public health pandemics such as COVID-19 on
business operations and expectations, as well as 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 June 30,
2021, 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.
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Scholar Rock Contacts: Investor Contact: Catherine
Hu chu@scholarrock.com Media Contact: Ariane Lovell Finn
Partners ariane.lovell@finnpartners.com 917-565-2204
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