On May 19, 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 a trials in progress poster presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held virtually from June 4-8, 2021 (Press release, Scholar Rock, MAY 19, 2021, View Source [SID1234580312]).
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The DRAGON Phase 1 proof-of-concept trial (NCT04291079) is evaluating 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. Dose escalation is progressing in Part A of the trial and the Company expects to advance to the Part B dose expansion portion of the trial in mid-2021.
The trials in progress e-poster will provide an overview of the design of the DRAGON Phase 1 trial and highlight the biomarker analysis being implemented to support the trial. Details of the poster presentation are as follows:
Session: Developmental Therapeutics–Molecularly Targeted Agents and Tumor Biology
Title: "First-in-Human Phase 1 Trial (DRAGON) of SRK-181: A Potential First-in-Class Selective Latent TGFβ1 Inhibitor, Alone or in Combination with Anti-PD-(L)1 Treatment in Patients with Advanced Solid Tumors" (TPS3146)
Date and Time: Friday, June 4, 11:00 AM – 2:00 PM EDT; Poster sessions available on demand in meeting library beginning 9:00 AM EDT on June 4, 2021.
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