Scholar Rock (NASDAQ: SRRK), a Phase 3, clinical-stage
biopharmaceutical company focused on the treatment of serious
diseases in which protein growth factors play a fundamental role,
today announced two upcoming presentations, – one at the American
College of Clinical Pharmacology Annual Meeting being held
September 25-27 in Bethesda, Maryland, and another at the 12th
Annual World Clinical Biomarkers & CDx Summit being held
September 26-29 in Boston, Massachusetts.
The presentations will provide insight into SRK-181, a selective
inhibitor of latent TGFβ1 activation being developed with the aim
of overcoming primary resistance to checkpoint therapy in advanced
cancer patients. Combination therapy with selective TGFβ1 blockade
may modulate the tumor microenvironment, allowing for immune cell
infiltration and potential improvements in the response rate and
survival time of cancer patients.
Specifically, the ACCP presentation will include new
pharmacokinetic data from the Phase 1 dose escalation study (DRAGON
Part A). The presentation at the World Clinical Biomarkers &
CDx Summit includes a discussion of pre-clinical validation studies
to assess biomarker utility, overcoming challenges and hurdles that
create barriers to assay translatability to the clinic, and early
clinical biomarker data including image-based analysis.
Details of the presentations are as follows:
ACCP Annual Meeting:
Title: Preliminary Population Pharmacokinetic Modeling of
SRK-181 from Phase 1 Dose Escalation Study Presentation
Type: Poster 015 Presenter: Amanda Hoerres, PharmD,
independent consultant for Scholar Rock and Senior Scientist II,
Clinical Pharmacologist, Vanadro Consulting Date/Time:
September 25, 5-7 p.m. ET
12th Annual World Clinical Biomarkers
& CDx Summit:
Title: Development of a Comprehensive Biomarker Strategy
for the Latent TGFβ1 Inhibitor SRK-181 Phase 1 Clinical Trial,
DRAGON Presentation Type: Oral Presenter: Si
Tuen Lee-Hoeflich, Senior Director, Translational Sciences at
Scholar Rock Date/Time: September 28, 3:25 p.m. ET
The presentations will be made available in the Publications
& Posters section of Scholar Rock’s website following the
conferences.
For conference information, visit https://accp1.org/ and
https://world-cdx.com/
About SRK-181
SRK-181 is a selective inhibitor of TGFβ1 activation 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. SRK-181 is an investigational product candidate and its
efficacy and safety 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, and
fibrosis. 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 www.ScholarRock.com or follow Scholar Rock on Twitter
(@ScholarRock) and LinkedIn
(https://www.linkedin.com/company/scholar-rock/). Investors and
others should note that we communicate with our investors and the
public using our company website www.scholarrock.com, including,
but not limited to, company disclosures, investor presentations and
FAQs, Securities and Exchange Commission filings, press releases,
public conference call transcripts, and webcast transcripts, as
well as on Twitter and LinkedIn. The information that we post on
our website or on Twitter or LinkedIn could be deemed to be
material information. As a result, we encourage investors, the
media and others interested to review the information that we post
there on a regular basis. The contents of our website or social
media shall not be deemed incorporated by reference in any filing
under the Securities Act of 1933, as amended.
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, and progress and indication selection and development
timing, 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,”
“could,” “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, without limitation, 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, and
Scholar Rock’s ability to manage expenses and to obtain additional
funding when needed to support its business activities, 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 March 31, 2022, 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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version on businesswire.com: https://www.businesswire.com/news/home/20220916005039/en/
Scholar Rock: Investors Rushmie Nofsinger Scholar Rock
rnofsinger@scholarrock.com ir@scholarrock.com 857-259-5573
Media Ariane Lovell Finn Partners ariane.lovell@finnpartners.com
media@scholarrock.com 917-565-2204
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