RESEARCH & DEVELOPMENT
Companion diagnostic for powering the cancer immunotherapy
T-cell mediated cancer immunotherapies such as PD-1/L1 inhibitors are increasingly becoming first line treatments in the treatment of solid cancer. While these breakthrough cancer treatments offer curative benefits in some patients, major challenges remain due to the high costs of treatment and low and unpredictable patient responses, leading to difficult issues surrounding insurance coverage and drug pricing policies for reimbursements by many governments.
Developed by Xylonix during its own immuno-oncology drug trial design optimization, the XDX-01 serum biomarker has demonstrated applicability in predicting the patient response and survival post PD-1 inhibitor treatments, with the prediction accountability of 88% and 79% for Objective Response Rate (ORR) and Progression-Free Survival (PFS), respectively, in site-agnostic manner. The current standard predictive biomarker, TMB, was shown to perform at 70% and 46%, respectively.
XDX-01 is being developed as a cartridge-based modular system on an FDA-approved point-of-care reader device. BioGemex and Xylonix are working together to jointly scale the manufacturing of XDX-01 and conduct broader clinical validation studies.
Singapore-based Xylonix is focused on "a new way of combating cancer through PARP-1 DNA-repair overdrive." Besides the XDX-01 biomarker, Xylonix's lead development candidates are onco-parthanatos agents C005D and C008D, which are being developed as monotherapies or for use with other immunotherapies.