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Scholar Rock Announces Initiation of Patient Dosing in Phase 1 Proof-of-Concept Immuno-Oncology Trial of SRK-181 to Overcome Primary Resistance to Anti-PD-(L)1 Therapy
- Dosing of patients with locally advanced or metastatic solid tumors has commenced in the DRAGON Phase 1 clinical trial of SRK-181, a highly specific
About this update from Scholar Rock Holding Corporation
[{"type":"text","content":"\n- Dosing of patients with locally advanced or metastatic solid tumors has commenced in the DRAGON Phase 1 clinical trial of SRK-181, a highly specific inhibitor of latent TGFβ1 activation\n\n\n- Update on dose escalation is expected in the fourth quarter of 2020; clinical response and safety data anticipated in 2021\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nScholar 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 the initiation of patient dosing in the DRAGON Phase 1 dose escalation and dose expansion clinical trial of SRK-181 in patients with locally advanced or metastatic solid tumors. SRK-181 is a potent and highly selective inhibitor of latent TGFβ1 activation and is being developed to increase responses to immunotherapy by overcoming primary resistance to anti-PD-1 or anti-PD-L1 antibody therapy.\n\n\n“Based on emerging evidence in the field from human and preclinical data implicating TGFβ1 as a key culprit in primary resistance to anti-PD-(L)1 therapy, we are excited to be investigating a rational approach to combination immunotherapy,” said Yung Chyung, M.D., Chief Medical Officer of Scholar Rock. “Our team’s focus and determination to advance SRK-181 and this Phase 1 trial, particularly as the evolving COVID-19 pandemic has resulted in various challenges, has been truly impressive. We remain committed to our mission of developing important therapies for patients and the initiation of dosing in this proof-of-concept trial represents an important milestone for us and our TGFβ1 platform.”\n\n\nDRAGON Phase 1 Proof-of-Concept Trial\n\n\nThe DRAGON Phase 1 open-label, dose escalation and dose expansion clinical trial is evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 in adult patients with locally advanced or metastatic solid tumors enrolled across multiple sites in the U.S. The two-part trial consists of a dose escalation portion (Part A) for SRK-181 as both a single agent and in combination with approved anti-PD-(L)1 therapy, followed by a dose expansion portion (Part B) evaluating SRK-181 in combination with approved anti-PD-(L)1 therapy in multiple tumor-specific cohorts. Intravenous (IV) SRK-181 is administered every 3 weeks (Q3W) ...