On October 31, 2024 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, reported 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) (Free SITC Whitepaper) 39th Annual Meeting in Houston on November 6–10 (Press release, Scholar Rock, OCT 31, 2024, View Source [SID1234647624]). 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.
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"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 (Free SITC Whitepaper)’s website on November 5, 2024: 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, 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.