DURHAM, N.C.--(BUSINESS WIRE)--GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, announced today the initiation of its Alamance study, a multi-center bladder cancer study conducted in collaboration with investigators at Memorial Sloan Kettering Cancer Center and the University of Wisconsin – Madison Carbone Cancer Center. Results from the study will be used to provide further clinical and analytical validation of GeneCentric’s fibroblast growth factor receptor predictive response signature (FGFR-PRS), which is a multi-gene RNA expression test that may help identify a larger population of patients who may achieve greater clinical benefit from FGFR-targeted therapy than from currently available fusion- and/or DNA mutation-based tests. The FGFR-PRS test is being developed in collaboration with Labcorp.
“While there has been significant progress in developing new treatment options for patients with locally advanced or metastatic bladder cancer, there remains a need for better predictive biomarkers and tests that can inform the optimal treatment for individual patients,” said Gopa Iyer, M.D., Alamance Study Lead Investigator and Section Head, Urothelial Cancer at Memorial Sloan Kettering Cancer Center. “Data from the Alamance study will be invaluable in this endeavor, especially with regards to developing novel tests to guide the use of FGFR-targeted and other therapies.”
In this prospectively designed real-world evidence study, clinical response data and existing tumor samples are being collected from a multi-center cohort of approximately 250 patients with locally advanced or metastatic urothelial (bladder) cancer treated with FGFR-targeted therapy (e.g., erdafitinib) or other standards of care (e.g., anti-PD-(L)1 or platinum-based chemotherapy). When complete, the Alamance study will include the largest retrospective cohort of patients treated with FGFR-targeted therapies to date.
The highly curated real-world clinical and demographic data with bulk tumor RNA transcriptome analysis from the Alamance study will be analyzed using GeneCentric’s RNA-based Tumor and Immune Micro-Environment (rT(I)ME) Explorer platform. In addition to the application of the FGFR-PRS to urothelial cancer patients, the clinicogenomic data will also be used to evaluate other signatures and tests in the growing pipeline that GeneCentric is developing in collaboration with pharmaceutical and biotechnology partners, as well as commercial reference labs.
GeneCentric Therapeutics, Inc. is an RNA-based genomic solutions provider based in Durham, North Carolina. The company designed its technologies to parse the complexity of tumor and immune biology using its RNA-based Tumor and Immune Micro-Environment (rT(I)ME) Explorer platform to discover and develop signatures of responder populations to oncology therapeutics. GeneCentric commercializes its technology through strategic collaborations with pharmaceutical, biotechnology and diagnostics companies in applications throughout preclinical testing, clinical drug development and commercialization lifecycle phases. For more information, visit www.genecentric.com or follow us on LinkedIn.