On September 28, 2021 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, reported 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) (Press release, Scholar Rock, SEP 28, 2021, View Source [SID1234590417]). This US patent includes composition-of-matter claims, providing product protection for SRK-181, a selective inhibitor of TGFβ1 activation that avoids binding to latent TGFβ2, latent TGFβ3, or any of the three active TGFβ 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.
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"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"
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"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 TGFβ1 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.
About SRK-181
SRK-181 is a selective inhibitor of TGFβ1 activation and is an investigational product candidate being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies. TGFβ1 is the predominant TGFβ isoform expressed in many human tumor types. Based on analyses of various human tumors that are resistant to anti-PD-(L)1 therapy, data suggest TGFβ1 is a key contributor to the immunosuppressive tumor microenvironment, excluding and preventing entry of cytotoxic T cells into the tumor, thereby inhibiting anti-tumor immunity (1). Scholar Rock believes SRK-181, which specifically targets the latent TGFβ1 isoform, 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 TGFβ inhibition. The DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) in patients with locally advanced or metastatic solid tumors is ongoing. The efficacy and safety of SRK-181 have not been established. SRK-181 has not been approved for any use by the FDA nor any other regulatory agency.
(1) Martin et al., Sci. Transl. Med. 12: 25 March 2020