Xylonix and BioGemex to Co-Develop Cancer Immunotherapy Response Diagnostic
Biotechnology firm Xylonix and diagnostic company BioGemex have signed a Memorandum of Understanding (MOU) to jointly develop XDX-01, a diagnostic test designed to predict patient response to cancer immunotherapies.
Singapore-based biotechnology firm Xylonix has entered into a Memorandum of Understanding (MOU) with South Korean diagnostic company BioGemex to jointly develop XDX-01. This diagnostic test aims to predict patient response to immunotherapies for solid tumors, particularly T-cell mediated treatments.
Cancer immunotherapies like PD-1 inhibitors have become increasingly common, but their high cost and unpredictable efficacy pose significant challenges. Many patients do not benefit, complicating insurance coverage and drug pricing. Xylonix developed the XDX-01 biomarker, which early validation studies suggest can predict patient response and survival following PD-1 inhibitor treatment. Its predictive accuracy for Objective Response Rate (ORR) reached 88%, and for Progression-Free Survival (PFS), it was 79%. The current standard, tumor mutational burden (TMB), achieves 70% and 46% respectively.
The collaboration aims to scale up the manufacturing of the XDX-01 test and conduct broader clinical validation studies, with a commercial launch targeted for the second half of 2020. Xylonix stated that XDX-01 could provide physicians, pharmaceutical companies, and payers with a reliable tool to ensure the right patients receive the right treatments.