On September 16, 2022 Scholar Rock (NASDAQ: SRRK), a Phase 3, clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported two upcoming presentations, – one at the American College of Clinical Pharmacology Annual Meeting being held September 25-27 in Bethesda, Maryland, and another at the 12th Annual World Clinical Biomarkers & CDx Summit being held September 26-29 in Boston, Massachusetts (Press release, Scholar Rock, SEP 16, 2022, View Source [SID1234619621]).
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The presentations will provide insight into SRK-181, a selective inhibitor of latent TGFβ1 activation being developed with the aim of overcoming primary resistance to checkpoint therapy in advanced cancer patients. Combination therapy with selective TGFβ1 blockade may modulate the tumor microenvironment, allowing for immune cell infiltration and potential improvements in the response rate and survival time of cancer patients.
Specifically, the ACCP presentation will include new pharmacokinetic data from the Phase 1 dose escalation study (DRAGON Part A). The presentation at the World Clinical Biomarkers & CDx Summit includes a discussion of pre-clinical validation studies to assess biomarker utility, overcoming challenges and hurdles that create barriers to assay translatability to the clinic, and early clinical biomarker data including image-based analysis.
Details of the presentations are as follows:
ACCP Annual Meeting:
Title: Preliminary Population Pharmacokinetic Modeling of SRK-181 from Phase 1 Dose Escalation Study
Presentation Type: Poster 015
Presenter: Amanda Hoerres, PharmD, independent consultant for Scholar Rock and Senior Scientist II, Clinical Pharmacologist, Vanadro Consulting
Date/Time: September 25, 5-7 p.m. ET
12th Annual World Clinical Biomarkers & CDx Summit:
Title: Development of a Comprehensive Biomarker Strategy for the Latent TGFβ1 Inhibitor SRK-181 Phase 1 Clinical Trial, DRAGON
Presentation Type: Oral
Presenter: Si Tuen Lee-Hoeflich, Senior Director, Translational Sciences at Scholar Rock
Date/Time: September 28, 3:25 p.m. ET
The presentations will be made available in the Publications & Posters section of Scholar Rock’s website following the conferences.
For conference information, visit View Source and View Source
About SRK-181
SRK-181 is a selective inhibitor of TGFβ1 activation 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. SRK-181 is an investigational product candidate and its efficacy and safety 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