[Edaily Reporter Kim Hyung-il ] Voronoi, Inc.(310210)announced on the 8th that it has added Malaysia to the list of regions for global clinical trials of its next-generation epidermal growth factor receptor (EGFR) targeted therapy, “VRN11.”

Voronoi, Inc. announced that the Investigational New Drug (IND) application for the global Phase 1b/2 clinical trial of VRN11 has been approved by the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia. With this approval, the Phase 1b/2 clinical trial of VRN11 will now proceed in Malaysia, following trials in Australia, Hong Kong, and Singapore.

The Malaysian trial is scheduled to take place at four major local medical institutions. At Hospital Umum Sarawak, Professor Pei-Jye Voon, who has participated in various anticancer drug clinical trials ranging from early- to late-stage trials, will serve as the principal investigator (PI).

Voronoi, Inc. plans to conduct global clinical trials in Australia, Hong Kong, Singapore, and Malaysia to gather efficacy and safety data on VRN11 across diverse patient populations.

VRN11 is a next-generation EGFR mutation-targeted therapy currently in development for EGFR-mutated non-small cell lung cancer. It demonstrated antitumor activity and a favorable safety profile in a previously conducted Phase 1a trial.

VRN11 is being developed to target various EGFR mutations, including the EGFR C797S mutation, which is one of the major mechanisms of resistance to third-generation EGFR-targeted therapies. Currently, clinical trials are underway in patients whose disease has progressed after receiving existing EGFR-targeted therapies, and the company is expanding clinical development to include treatment-naïve patients to evaluate its potential as a first-line therapy.

Voronoi, Inc. spokesperson stated, “With this approval, the global clinical trial for VRN11 has expanded to Malaysia,” adding, “We will conduct the trial in collaboration with researchers at four major medical institutions in Malaysia who have extensive experience in clinical trials of various anticancer drugs to gather data on the efficacy and safety of VRN11.”