Scholar Rock announced new data from its Phase 1 DRAGON proof-of-concept trial of SRK-181, a selective inhibitor of latency TGFb1 activation being developed with the aim of overcoming resistance to checkpoint inhibitor therapy in patients with advanced cancer. These data will be presented in two poster presentations during the Society for Immunotherapy of Cancer's (SITC) 38th Annual Meeting & Pre-Conference being held November 1 - 5th in San Diego. The first poster focuses on the safety, efficacy, and preliminary biomarker data in patients with anti-PD-1 resistant clear cell renal cell carcinoma (ccRCC) in Part A2 (dose escalation) and Part B (dose expansion) of the Phase 1 DRAGON trial.

The second poster focuses on preliminary biomarker data from part B of the trial in patients with multiple tumor types. Data presented continues to support proof of concept for SRK-181 in 28 heavily pretreated patients with ccRCC resistant to anti-PD-1. SRK-181 was generally well tolerated and showed promising anti-tumor activity in this patient population. 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 TGFb 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 has not been approved for any use by the FDA or any other regulatory agency.

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