On January 25, 2022 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 presentation at the 2nd Annual TGFβ for Immuno-Oncology Drug Development Summit (January 25-27, 2022) (Press release, Scholar Rock, JAN 25, 2022, View Source [SID1234606786]).
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"Development of a Comprehensive Biomarker Strategy to Support DRAGON, a Phase 1 Clinical Trial of SRK-181, the latent TGFβ1 Inhibitor" will be presented on January 27th, 2022, at 11:00 AM EST. The presentation, led by Si Tuen Lee-Hoeflich, Director, Translational Sciences at Scholar Rock, will discuss the SRK-181 biomarker strategy in relation to the DRAGON Phase 1 proof-of-concept trial (NCT04291079). The goal of the trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with an anti-PD-(L)-1 in adult patients with locally advanced or metastatic solid tumors. The biomarker strategy will focus on the evaluation of biomarkers relevant to the mechanism of action of SRK-181 to facilitate the clinical development of Scholar Rock’s immuno-oncology (IO) program and to identify the next wave of IO biomarkers that correlate with anti-tumor response.
"We are excited to be presenting at the TGFβ for Immuno-Oncology Drug Development Summit on our biomarker strategy for SRK-181 in support of DRAGON," said Gregory Carven, Ph.D., Chief Scientific Officer. "Our biomarker efforts play an important role in advancing our understanding of the mechanisms of action of selective inhibition of TGFβ1 and for facilitating the development of SRK-181, which we hope will positively impact the lives of those affected by cancers that are resistant to checkpoint blockade."
Initial Part A data from the ongoing DRAGON trial in patients with locally advanced or metastatic solid tumors were presented by Scholar Rock at the 36th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2021, supporting dose selection and advancement into Part B. Part B will assess SRK-181 in combination with an approved anti-PD-(L)1 therapy across multiple solid tumor cohorts to test proof of concept. To learn more about DRAGON, visit clinicaltrials.gov.
For Summit information, visit: www.tgf-beta-summit.com
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