- Poster presentation to include new safety, efficacy, and
biomarker data from the long-term expansion phase of the DRAGON
trial in patients with advanced solid tumors treated with
SRK-181
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical
company focused on advancing innovative treatments for spinal
muscular atrophy (SMA), cardiometabolic disorders, and other
serious diseases where protein growth factors play a fundamental
role, announced today that it will present data from the Phase 1
DRAGON trial of SRK-181, an investigational selective inhibitor of
latent TGFβ1 activation, in patients with advanced solid tumors at
the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting
in Houston on November 6–10. In a poster presentation, Scholar Rock
will share updated safety, efficacy, and biomarker results for
SRK-181 in anti-PD-1 resistant patients with advanced solid tumors
from the expansion phase (Part B) of the DRAGON trial.
“These promising new clinical and biomarker data from the DRAGON
trial build upon our robust safety and efficacy data on SRK-181 in
multiple solid tumor types,” said Jay Backstrom, M.D., MPH,
President and Chief Executive Officer of Scholar Rock. “We are
excited to share these updates, which support the potential of our
highly selective approach to inhibiting TGFβ1 with durable
responses observed in heavily pretreated patients. While DRAGON
completed enrollment last year, patients have remained on therapy,
and we look forward to providing additional updates.”
Details of the presentations are as follows:
Title: DRAGON Trial: Durable remission rate with the
latent TGFβ1 inhibitor linavonkibart (SRK-181) and pembrolizumab in
patients with immune checkpoint inhibitor resistant advanced
cancers Presentation Type: Poster 812 Presenter:
Timothy A. Yap, M.D., The University of Texas MD Anderson Cancer
Center Location: Level 1, Exhibit Halls AB, George R. Brown
Convention Center, Houston, TX Date/Time: November 9, 2024,
7:10-8:30 p.m. CST
The abstracts for these presentations are available on SITC’s
website on November 5, 2024:
https://www.sitcancer.org/2024/abstracts/titles-and-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/2024/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,
as well as suppressing T cell activity, thereby inhibiting
anti-tumor immunity.
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 immunosuppressive tumor microenvironment and induce tumor
regression when administered in combination with anti-PD-(L)1
therapy while potentially avoiding toxicities associated with
non-selective TGFβ inhibition. Enrollment of the DRAGON Phase 1
proof-of-concept clinical trial (NCT04291079) was completed in
December 2023, and patients who remain on the study continue to be
treated. The trial enrolled 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.
About Scholar Rock
Scholar Rock is a biopharmaceutical company that discovers,
develops, and delivers life-changing therapies for people with
serious diseases that have high unmet need. As a global leader in
the biology of the transforming growth factor beta (TGFβ)
superfamily of cell proteins and named for the visual resemblance
of a scholar rock to protein structures, the clinical-stage company
is focused on advancing innovative treatments where protein growth
factors are fundamental. Over the past decade, Scholar Rock has
created a pipeline with the potential to advance the standard of
care for neuromuscular disease, cardiometabolic disorders, cancer,
and other conditions where growth factor-targeted drugs can play a
transformational role.
This commitment to unlocking fundamentally different therapeutic
approaches is powered by broad application of a proprietary
platform, which has developed novel monoclonal antibodies to
modulate protein growth factors with extraordinary selectivity. By
harnessing cutting-edge science in disease spaces that are
historically under-addressed through traditional therapies, Scholar
Rock works every day to create new possibilities for patients.
Learn more about our approach at ScholarRock.com and follow
@ScholarRock and on LinkedIn.
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, progress and timing of its clinical trials for SRK-181,
and indication selection and development timing, including the
therapeutic potential, clinical benefits and safety thereof,
expectations regarding timing, success and data announcements of
current ongoing clinical trials, 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 preclinical and clinical data, including
the results from the Phase 1 clinical trial of SRK-181, are not
predictive of, may be inconsistent with, or more favorable than,
data generated from future or ongoing 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; 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; Scholar
Rock’s dependence on third parties for development and manufacture
of product candidates including, without limitation, to supply any
clinical trials; and 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; 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, 2024,
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241031472436/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
Scholar Rock (NASDAQ:SRRK)
Historical Stock Chart
Von Nov 2024 bis Dez 2024
Scholar Rock (NASDAQ:SRRK)
Historical Stock Chart
Von Dez 2023 bis Dez 2024