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Scholar Rock Presents Preclinical Data for SRK-181 at the TGFβ for Immuno-Oncology Drug Development Summit

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Scholar Rock (NASDAQ: SRRK) announced participation at the 2021 TGFβ for Immuno-Oncology Drug Development Summit. On January 28, 2021, they will present preclinical data on SRK-181, a selective inhibitor of TGFβ1, showing its potential to enhance the effects of checkpoint inhibitor therapy. The presentation indicates improved tumor growth control and a favorable toxicity profile. SRK-181 is currently undergoing a Phase 1 trial aimed at patients with advanced solid tumors, but it has not yet been approved by the FDA.

Positive
  • Presentation of promising preclinical data for SRK-181 at a prominent summit.
  • SRK-181 shows potential to enhance checkpoint inhibitor therapy effectiveness.
  • Ongoing Phase 1 trial indicates progress in SRK-181's development.
Negative
  • SRK-181 has not received FDA approval.
  • Effectiveness and safety of SRK-181 have not been established.

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 a presentation at the 2021 TGFβ for Immuno-Oncology Drug Development Summit.

“Inhibition of TGFβ1 Activation with SRK-181 Overcomes Primary Resistance to Checkpoint Inhibition Therapy” will be presented on January 28th, 2021 at 12:30 PM EST. The presentation will provide an overview of the preclinical data demonstrating selective inhibition of TGFβ1 activation with SRK-181-mIgG1 (murine version of SRK-181) induces combination treatment effects with anti-PD-1 on tumor growth in checkpoint inhibition therapy-resistant tumors as well as an improved preclinical toxicity profile compared to less selective TGFβ inhibition.

Scholar Rock will also be participating in a panel discussion titled “Debating the Best Approach to Target TGF-β” on January 27th, 2021 at 10:45 am EST.

About SRK-181

SRK-181 is a potent and highly 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 tumors, particularly for those tumors where checkpoint therapies are currently approved. Based on analyses of human tumors that are resistant to anti-PD-(L)1 therapy, data suggests TGFβ1 is a key contributor to excluding immune cell entry into the tumor microenvironment, thereby preventing normal immune function. Scholar Rock believes 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. By specifically targeting the latent TGFβ1 isoform, Scholar Rock hypothesizes that SRK-181 can increase the therapeutic window by potentially avoiding toxicities associated with non-selective TGFβ inhibition. A Phase 1 proof-of-concept clinical trial in patients with locally advanced or metastatic solid tumors is ongoing. The effectiveness and safety of SRK-181 have not been established and SRK-181 has not been approved for any use by the FDA or any other regulatory agency.

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 www.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 the potential of SRK-181 to address certain patient unmet needs and the ability of any product candidate to perform in humans in a manner consistent with earlier nonclinical, preclinical or clinical trial data. 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 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 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 September 30, 2020, 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.

FAQ

What is the purpose of SRK-181?

SRK-181 is developed to inhibit TGFβ1 and overcome resistance to checkpoint inhibitor therapy.

When is the presentation about SRK-181 scheduled?

The presentation is scheduled for January 28, 2021, at 12:30 PM EST.

What trial is currently ongoing for SRK-181?

A Phase 1 proof-of-concept clinical trial for SRK-181 is currently ongoing.

Has SRK-181 been approved by regulatory agencies?

No, SRK-181 has not been approved for any use by the FDA or other regulatory agencies.

What are the potential benefits of SRK-181?

SRK-181 aims to enhance tumor regression when used with anti-PD-(L)1 therapies while minimizing side effects.

Scholar Rock Holding Corporation

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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
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