On May 28, 2024 Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, reported it will present new data from its Phase 1 DRAGON proof-of-concept trial of SRK-181 in combination with pembrolizumab in patients with advanced solid tumors in an oral presentation during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 31 – June 4 in Chicago (Press release, Scholar Rock, MAY 28, 2024, View Source [SID1234643758]). Those data will be discussed further during a webcast on June 4th at 7 a.m. CDT/8 a.m. EDT that includes Jing Marantz, M.D., Ph.D., Chief Medical Officer at Scholar Rock, and Dr. Toni Choueiri, M.D., Director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber Cancer Institute (DFCI).
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"We continued to observe encouraging responses and tolerability in heavily pretreated patients across multiple cancer types, providing further evidence of SRK-181’s potential to overcome resistance to immune checkpoint inhibitors," said Jay Backstrom, M.D., M.P.H., President and Chief Executive Officer of Scholar Rock. "In addition, biomarker data indicated that treatment with SRK-181 is associated with an enhanced proinflammatory microenvironment and increased anti-tumor activity. Together, these new data provide further validation of the selective approach of our TGFβ platform. We look forward to sharing additional updated data at ASCO (Free ASCO Whitepaper)."
Data highlights are as follows:
– SRK-181 continued to be well tolerated in the dose expansion portion of the DRAGON trial (Part B).
– Encouraging responses were observed across multiple cancer types, including clear cell renal cell carcinoma (ccRCC), head and neck squamous cell carcinoma (HNSCC), melanoma (MEL), and urothelial carcinoma (UC).
– Biomarker data showed that the SRK-181 + pembrolizumab treatment combination created an enhanced proinflammatory microenvironment in anti-PD-(L)1 resistant patients.
– Patients with ccRCC whose tumors were infiltrated at baseline by CD8+ T cells and/or regulatory T cells showed positive correlations between infiltration of each cell type and response rate. This positive correlation between baseline infiltration status type and response rate suggests a potential patient selection strategy.
These results will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting in an oral presentation, details of which can be found below.
Title: Phase 1 study (DRAGON) of SRK-181 (linavonkibart), a latent TGFβ1 inhibitor, combined with pembrolizumab in anti-PD1 resistant patients with advanced solid tumors: Updated results of expansion part
Oral Session: Developmental Therapeutics—Immunotherapy
Presenter: Ulka N. Vaishampayan, MD, Division of Hematology/Oncology, University of Michigan
Location: Hall D2
Date/Time: June 3, 1:50 p.m. CDT
Conference Call Information
Scholar Rock will host a conference call on June 4 at 8 a.m. EDT that can be accessed by registering in advance at the Events and Presentations page of Scholar Rock’s website. Members of Scholar Rock’s executive management team will be joined by Dr. Toni Choueiri, M.D., Director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber Cancer Institute (DFCI).
The abstracts for these presentations are available on ASCO (Free ASCO Whitepaper)’s website View Source The presentations will be made available in the Publications & Posters section of Scholar Rock’s website following the conference.
For conference information, visit 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, in advanced cancer. 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 that 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. (2) SRK-181 specifically targets the latent TGFβ1 isoform in a context-independent manner, designed to enable complete inhibition of TGFβ1 in all compartments within the tumor microenvironment. Scholar Rock believes that SRK-181 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. Enrollment of the DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) was completed in December 2023, and patients who remain on the study continue to be treated. The trial enrolled patients in multiple proof of concept cohorts conducted in parallel, including urothelial carcinoma (UC), cutaneous melanoma (MEL), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and clear cell renal cell carcinoma (ccRCC). 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 or any other regulatory agency.