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Scholar Rock Presents Data from Part A of the DRAGON Phase 1 Trial Evaluating SRK-181 as Monotherapy and in Combination with Anti-PD-(L)1 for the Treatment of Solid Tumors -- Announces Advancement into Part B
- Safety and pharmacokinetic results from Part A dose escalation supported Part B dose selection, which is estimated to offer drug exposure at levels
About this update from Scholar Rock Holding Corporation
[{"type":"text","content":"\n- Safety and pharmacokinetic results from Part A dose escalation supported Part B dose selection, which is estimated to offer drug exposure at levels exceeding those hypothesized as needed for anti-tumor effects\n\n- Part B dose expansion portion of the DRAGON trial has been initiated and will assess SRK-181 in combination with an approved anti-PD-(L)1 therapy across multiple solid tumor cohorts to test proof of concept; early efficacy and safety data anticipated in 2022 \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 presented initial clinical data from Part A of its DRAGON Phase 1 proof-of-concept trial (NCT04291079) at the ongoing 36th Society for Immunotherapy of Cancer (SITC) Annual Meeting (November 10-14, 2021), which supported dose selection and advancement into Part B. The DRAGON trial is investigating SRK-181, a selective inhibitor of TGFβ1 activation, in patients with locally advanced or metastatic solid tumors that have shown primary resistance to checkpoint inhibitor therapies.\n\nThe main objectives of DRAGON Part A are to evaluate the safety and tolerability of SRK-181 alone (Part A1) or in combination with anti-PD-(L)1 checkpoint inhibitor therapy (Part A2) and to determine the recommended dose for the Part B dose expansion phase. Part A1 enrolled patients who have experienced treatment failure from available standard of care therapy, and Part A2 enrolled patients who did not respond to prior anti-PD-(L)1 therapy. Based on the safety and pharmacokinetic data from Part A, Scholar Rock has initiated Part B, which is evaluating SRK-181 dosed 1500 mg every three weeks (Q3W) in patients receiving an approved anti-PD-(L)1 therapy dosed Q3W and 1000 mg every two weeks (Q2W) in patients receiving an approved anti-PD-(L)1 therapy dosed Q2W.\n\n“While checkpoint inhibitor therapy has definitely advanced the treatment of cancer, resistance to this type of therapy remains a very significant unmet medical need,” said Nagesh Mahanthappa, Ph.D., Interim CEO. “We are excited that the DRAGON Part A results support moving forward in Part B with a dose of SRK-181 aimed at robustly suppressing TGFβ1 signaling, and look forward to advancing our program to test ...