- Updated safety and efficacy results on
SRK-181 will be featured in an oral presentation on Monday, June
3rd, at 1:50 p.m CDT/2:50 p.m. EDT - Company will host conference
call to discuss the data on Tuesday, June 4th at 7:00 a.m. CDT/8:00
a.m. EDT
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, today announced it will present new data from its Phase 1
DRAGON proof-of-concept trial of SRK-181 in combination with
pembrolizumab in patients with advanced solid tumors in an oral
presentation during the American Society of Clinical Oncology
(ASCO) Annual Meeting being held May 31 – June 4 in Chicago. Those
data will be discussed further during a webcast on June 4th at 7
a.m. CDT/8 a.m. EDT that includes Jing Marantz, M.D., Ph.D., Chief
Medical Officer at Scholar Rock, and Dr. Toni Choueiri, M.D.,
Director of the Lank Center for Genitourinary (GU) Oncology at
Dana-Farber Cancer Institute (DFCI).
“We continued to observe encouraging responses and tolerability
in heavily pretreated patients across multiple cancer types,
providing further evidence of SRK-181’s potential to overcome
resistance to immune checkpoint inhibitors,” said Jay Backstrom,
M.D., M.P.H., President and Chief Executive Officer of Scholar
Rock. “In addition, biomarker data indicated that treatment with
SRK-181 is associated with an enhanced proinflammatory
microenvironment and increased anti-tumor activity. Together, these
new data provide further validation of the selective approach of
our TGFβ platform. We look forward to sharing additional updated
data at ASCO.”
Data highlights are as follows:
- SRK-181 continued to be well tolerated in
the dose expansion portion of the DRAGON trial (Part B).
- Encouraging responses were observed across
multiple cancer types, including clear cell renal cell carcinoma
(ccRCC), head and neck squamous cell carcinoma (HNSCC), melanoma
(MEL), and urothelial carcinoma (UC).
- Biomarker data showed that the SRK-181 +
pembrolizumab treatment combination created an enhanced
proinflammatory microenvironment in anti-PD-(L)1 resistant
patients.
- Patients with ccRCC whose tumors were
infiltrated at baseline by CD8+ T cells and/or regulatory T cells
showed positive correlations between infiltration of each cell type
and response rate. This positive correlation between baseline
infiltration status type and response rate suggests a potential
patient selection strategy.
These results will be presented at the ASCO Annual Meeting in an
oral presentation, details of which can be found below.
Title: Phase 1 study (DRAGON) of SRK-181 (linavonkibart),
a latent TGFβ1 inhibitor, combined with pembrolizumab in anti-PD1
resistant patients with advanced solid tumors: Updated results of
expansion part Oral Session: Developmental
Therapeutics—Immunotherapy Presenter: Ulka N. Vaishampayan,
MD, Division of Hematology/Oncology, University of Michigan
Location: Hall D2 Date/Time: June 3, 1:50 p.m.
CDT
Conference Call Information Scholar Rock will host a
conference call on June 4 at 8 a.m. EDT that can be accessed by
registering in advance at the Events and Presentations page of
Scholar Rock’s website. Members of Scholar Rock’s executive
management team will be joined by Dr. Toni Choueiri, M.D., Director
of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber
Cancer Institute (DFCI).
The abstracts for these presentations are available on ASCO’s
website https://conferences.asco.org/am/abstracts. The
presentations will be made available in the Publications &
Posters section of Scholar Rock’s website following the
conference.
For conference information, visit
https://conferences.asco.org/.
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. (2)
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. 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.
Scholar Rock is the only company to show clinical proof of
concept for a muscle-targeted treatment in spinal muscular atrophy
(SMA). 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 preclinical and 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 March 31, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240528070137/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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