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Recent Phase 1 DRAGON Data Show SRK-181 Continues to be Well Tolerated with Early Indications of Efficacy
- All doses were generally well tolerated, no dose limiting toxicities observed including at the Part B dose of 1500 mg - Biomarker data consistent with
About this update from Scholar Rock Holding Corporation
[{"type":"text","content":"\n- All doses were generally well tolerated, no dose limiting toxicities observed including at the Part B dose of 1500 mg\n\n- Biomarker data consistent with target engagement\n\n- Two confirmed partial responses observed in patients with anti-PD-1 resistant clear cell renal cell carcinoma\n\n- Enrollment of DRAGON Part B continues to progress\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nScholar 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, today announced early data from its Phase 1 DRAGON proof-of-concept trial of SRK-181, a selective inhibitor of latent TGFβ1 activation being developed with the aim of overcoming resistance to checkpoint therapy in patients with advanced cancer. The data were shared in a poster presentation during the Society for Immunotherapy of Cancer's (SITC) 37th Annual Meeting & Pre-Conference being held November 8-12 in Boston.\n\n“Resistance to checkpoint inhibitor therapy remains a significant challenge in the treatment of advanced cancer. The DRAGON trial is investigating our novel TGFβ1 selective monoclonal antibody, SRK-181, which was designed to address this challenge based on the strong, scientific rationale that TGFβ1 is a driving mechanism of resistance to checkpoint inhibitors. Our preclinical work suggests that SRK-181 may overcome this resistance and avoid the cardiotoxicities that have limited other non-selective approaches,” said Jay Backstrom, M.D., M.P.H., President and Chief Executive Officer of Scholar Rock. “These early DRAGON findings of safety, target engagement and indications of efficacy support our conviction around Scholar Rock’s differentiated approach and the potential role that SRK-181 may play in addressing the existing treatment hurdles. We are excited to continue advancing DRAGON and look forward to sharing additional data next year.”\n\nData continue to show SRK-181 is generally well tolerated\nSafety data from the dose escalation portion of the trial (Part A) continue to show SRK-181 is generally well tolerated when used alone or in combination with anti-PD-(L)1 checkpoint inhibitor therapy. No dose-limiting toxicities were observed in patients receiving SRK-181 as monotherapy (Part A1) when dosed up to 3000 mg once every three weeks (q3w) or 2000 m...