Voronoi, Inc. Expands VRN11 Global Clinical Trials to Malaysia

[Financial News] Voronoi, Inc. is expanding the global clinical trial region for its next-generation EGFR-targeted therapy, 'VRN11,' to Malaysia.
According to a disclosure on the 8th, Voronoi, Inc. received approval from Malaysia's National Pharmaceutical Regulatory Agency (NPRA) for its global Phase 1b/2 Investigational New Drug (IND) application for VRN11.
With this approval, Malaysia has been added to the VRN11 global Phase 1b/2 clinical trial network, following Australia, Hong Kong, and Singapore. Voronoi, Inc. plans to conduct clinical trials in multiple countries to secure efficacy and safety data for VRN11 across diverse patient populations.
The Malaysian clinical trial will be conducted at four major local medical institutions. At Sarawak General Hospital, Professor Pei-Jye Voon, who has experience in anticancer drug clinical trials, will participate as the principal investigator (PI).
VRN11 is a therapy under development for EGFR-mutated non-small cell lung cancer. Its antitumor efficacy and safety profile were confirmed in the previously conducted Phase 1a trial.
In particular, it targets various EGFR mutations, including EGFR C797S, one of the major causes of resistance to third-generation EGFR-targeted therapies. Clinical trials are currently being conducted in patients whose disease has progressed after treatment with existing EGFR-targeted therapies. The development program will also be expanded to treatment-naive patients to assess VRN11's potential as a first-line treatment.
"With this approval, we have expanded VRN11's global clinical trial region to Malaysia," a Voronoi, Inc. official said. "We will work with major local medical institutions to secure efficacy and safety data across diverse patient populations."

[email protected] Jeong Sang-hee Reporter