On October 19, 2023 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, reported 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) (Free SITC Whitepaper) 38th Annual Meeting in San Diego on November 1-5 (Press release, Scholar Rock, OCT 19, 2023, View Source [SID1234636162]). 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.
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"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 (Free SITC Whitepaper)’s website on Oct 31, 2023: View Source
The presentations will be made available in the Publications & Posters section of Scholar Rock’s website following the conference.
For conference information, visit View Source
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.