- Poster presentations to include safety,
efficacy, and biomarker data from Part A and B of the DRAGON trial
in patients with advanced solid tumors treated with SRK-181
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,
announced today that it will present data from DRAGON, a Phase 1
study of SRK-181 in patients with advanced solid tumors at the
Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in
San Diego on November 1-5. In one poster presentation, Scholar Rock
will share preliminary biomarker data from Part B of the trial, and
in a second poster presentation, provide safety, efficacy, and
biomarker results of SRK-181 in anti-PD-1 resistant metastatic
clear cell renal cell carcinoma (ccRCC) patients from both Parts A
and B.
“We are excited to present clinical and biomarker updates on the
DRAGON study, which build upon the safety and efficacy data to date
in the ccRCC cohort of the trial and support our goal of
establishing the proof of mechanism of SRK-181,” said Jay
Backstrom, M.D., MPH, President and Chief Executive Officer of
Scholar Rock. “As a selective latent TGFβ1 inhibitor, SRK-181 has
the potential to transform cancer immunotherapy by helping to
overcome resistance to checkpoint inhibitor therapy. This
investigational medicine demonstrates the promise of Scholar Rock’s
unique discovery platform.”
Details of the presentations are as follows:
Title: Establishing Proof of Mechanism in Patients:
Preliminary Biomarker Data of SRK-181 (a latent TGFβ1 inhibitor)
from DRAGON Study Presentation Type: Poster 726
Presenter: Susan Henry, PhD, Senior Director, Translational
Sciences, Scholar Rock, Inc. Location: Exhibit Halls A and
B1, San Diego Convention Center Date/Time: November 4, 11:55
AM – 1:25 PM PDT and 7 – 8:30 PM PDT
Title: Safety, efficacy, and biomarker results of
SRK-181, a latent TGFβ1 inhibitor, in anti-PD-1 resistant
metastatic ccRCC patients Presentation Type: Poster 666
Presenter: Timothy Yap, MBBS, PhD, FRCP, Medical Oncologist
and Physician-Scientist; and Associate Professor, Department of
Investigational Cancer Therapeutics, University of Texas MD
Anderson Cancer Center Location: Exhibit Halls A and B1, San
Diego Convention Center Date/Time: November 4, 11:55 AM –
1:25 PM PDT and 7 – 8:30 PM PDT
The abstracts for these presentations will be available on
SITC’s website on Oct 31, 2023:
https://www.sitcancer.org/2023/abstracts/abstract-titles-publications
The presentations will be made available in the Publications
& Posters section of Scholar Rock’s website following the
conference.
For conference information, visit
https://www.sitcancer.org/2023/home
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, in advanced cancer. 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 that 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) SRK-181 specifically
targets the latent TGFβ1 isoform in a context-independent manner,
designed to enable complete inhibition of TGFβ1 in all compartments
within the tumor microenvironment. Scholar Rock believes that
SRK-181 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 trial
is currently enrolling and dosing patients in multiple proof of
concept cohorts conducted in parallel, including urothelial
carcinoma (UC), cutaneous melanoma (MEL), non-small cell lung
cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and
clear cell renal cell carcinoma (ccRCC). 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 or 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/).
Availability of Other Information About 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, that
clinical data, including the results from the Phase 2 clinical
trial of apitegromab, or Part B of the Phase 1 clinical trial of
SRK-181, and are not predictive of, may be inconsistent with, or
more favorable than, data generated from future clinical trials of
the same product candidates, 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 June 30, 2023, 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/20231019350680/en/
Scholar Rock: Investors Rushmie Nofsinger Scholar
Rock rnofsinger@scholarrock.com ir@scholarrock.com 857-259-5573
Media Molly MacLeod Scholar Rock mmacleod@scholarrock.com
media@scholarrock.com 802-579-5995
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