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Xylonix, BioGemex Ink MOU to Develop Point-of-Care Cancer Immunotherapy-Response Diagnostic

NEW YORK — Xylonix, an immuno-oncology biotech, and cancer diagnostics firm BioGemex announced today a memorandum of understanding to codevelop a predictive cancer immunotherapy treatment response diagnostic. 

The companies will jointly develop XDX-01, a pretreatment point-of-care diagnostic to predict a patient's reaction to T-cell mediated cancer immunotherapies in solid tumors. 

The XDX-01 serum biomarker was developed by Xylonix, and the diagnostic will be developed as a cartridge-based modular system. The companies are partnering to scale the manufacturing of XDX-01 and conduct additional studies for a commercial launch next year, they said. 

They noted that the XDX-01 biomarker has demonstrated the ability to predict patient response and survival after PK-1 inhibitor treatment with prediction accountability of 88 percent and objective response rate (ORR) and progression-free survival (PFS) of 79 percent in site-agnostic manner. By comparison, tumor mutational burden, the standard predictive biomarker, has prediction accountability of 70 percent and ORR and PFS of 46 percent, the partners said. 

"The rising costs of cancer treatment remains a pressing global issue, but physicians, pharmaceutical companies and payors are yet to find a reliable tool to ensure that the right patients get the right treatments," Jinhyuk Chung, the founder and chief scientific officer of Xylonix, said in a statement. "We believe that XDX-01 has the potential to be the right decision-support tool."

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. 

Seoul, Korea-based BioGemex works to accelerate clinical investigations of cancer immunotherapies. The company also produces original design manufacturer and original equipment manufacturer pregnancy test kits.