Benzinga | Sep 28, 2021 04:03PM EDT

SCholar Rock Reports US Patent Issued Protecting SRK-181 As Inhibitor Of TGF1 Activation

Scholar 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 that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,130,803, with an expiry of May 2040, including 313 days of Patent Term Adjustment (PTA). This US patent includes composition-of-matter claims, providing product protection for SRK-181, a selective inhibitor of TGF?1 activation that avoids binding to latent TGF?2, latent TGF?3, or any of the three active TGF? growth factors. SRK-181 is an investigational clinical candidate being developed to overcome primary resistance to and increase the number of patients who could benefit from checkpoint inhibitors, such as anti-PD-(L)1 therapies.

"This is another important addition to our patent portfolio providing product protection for SRK-181 as we continue to progress the DRAGON Phase 1 trial in patients with locally advanced or metastatic solid tumors," said Nagesh Mahanthappa, Ph.D., Interim CEO of Scholar Rock. "As we observed in preclinical studies, our hypothesis remains that a selective approach to targeting the TGF?1 isoform could allow for an improved safety and efficacy profile compared to non-selective approaches and we're very excited to continue pursuing our unique approach to provide potential clinical benefit for patients who are resistant to treatment with PD-(L)1 inhibitors."

SRK-181 is being evaluated in the two-part DRAGON trial (NCT04291079) in patients with locally advanced or metastatic solid tumors exhibiting primary resistance to anti-PD-(L)1 therapy. Part A dose escalation is evaluating the safety and pharmacokinetics of SRK-181 as a single-agent and in combination with anti-PD-(L)1 therapy to identify the recommended dose for Part B of the trial. Part B dose expansion will consist of multiple cohorts, including urothelial carcinoma, cutaneous melanoma, non-small cell lung cancer, and other solid tumors and patients will be treated with SRK-181 in combination with an anti-PD-(L)1 therapy. An update on dose escalation and initial clinical data from Part A of the DRAGON trial is anticipated by year-end.