Voronoi Receives Malaysian Phase 1b/2 IND Approval for EGFR Targeted Therapy VRN11... Expands Global Clinical Trial
2026.09.08
■ Clinical trial to be conducted at four major medical institutions in Malaysia... Expanding Southeast Asian clinical network
Voronoi (310210) announced through a disclosure on the 7th that the global Phase 1b/2 IND (clinical trial plan) for 'VRN11,' its next-generation EGFR targeted therapy, has been approved by Malaysia's National Pharmaceutical Regulatory Agency (NPRA).
With this approval, Malaysia has been added to VRN11's global Phase 1b/2 clinical network. The company plans to conduct global clinical trials in Australia, Hong Kong, Singapore, Malaysia, and elsewhere to secure efficacy and safety data on VRN11 across diverse patient groups.
The Malaysian trial will be conducted at four major local medical institutions. In particular, at Sarawak General Hospital (Hospital Umum Sarawak), Professor Pei-Jye Voon, who has participated in a wide range of anticancer drug clinical trials from early-phase to late-phase studies, will participate as Principal Investigator (PI).
VRN11 is a next-generation EGFR mutation targeted therapy under development for EGFR mutation non-small cell lung cancer, and has demonstrated an antitumor effect and an excellent safety profile in the previously conducted Phase 1a trial.
VRN11 is being developed to target a variety of EGFR mutations, including the EGFR C797S mutation, one of the major resistance mechanisms to third-generation EGFR targeted therapies. It is currently in clinical trials in patients whose disease has progressed after administration of existing EGFR targeted therapies, and clinical development is being expanded to treatment-naïve patients to also confirm its potential as a first-line treatment.
A Voronoi representative said, "With this approval, VRN11's global clinical trial has expanded to Malaysia. We will conduct the trial at four major medical institutions in Malaysia together with investigators experienced in a wide range of anticancer drug trials, and secure efficacy and safety data on VRN11."
Voronoi (310210) announced through a disclosure on the 7th that the global Phase 1b/2 IND (clinical trial plan) for 'VRN11,' its next-generation EGFR targeted therapy, has been approved by Malaysia's National Pharmaceutical Regulatory Agency (NPRA).
With this approval, Malaysia has been added to VRN11's global Phase 1b/2 clinical network. The company plans to conduct global clinical trials in Australia, Hong Kong, Singapore, Malaysia, and elsewhere to secure efficacy and safety data on VRN11 across diverse patient groups.
The Malaysian trial will be conducted at four major local medical institutions. In particular, at Sarawak General Hospital (Hospital Umum Sarawak), Professor Pei-Jye Voon, who has participated in a wide range of anticancer drug clinical trials from early-phase to late-phase studies, will participate as Principal Investigator (PI).
VRN11 is a next-generation EGFR mutation targeted therapy under development for EGFR mutation non-small cell lung cancer, and has demonstrated an antitumor effect and an excellent safety profile in the previously conducted Phase 1a trial.
VRN11 is being developed to target a variety of EGFR mutations, including the EGFR C797S mutation, one of the major resistance mechanisms to third-generation EGFR targeted therapies. It is currently in clinical trials in patients whose disease has progressed after administration of existing EGFR targeted therapies, and clinical development is being expanded to treatment-naïve patients to also confirm its potential as a first-line treatment.
A Voronoi representative said, "With this approval, VRN11's global clinical trial has expanded to Malaysia. We will conduct the trial at four major medical institutions in Malaysia together with investigators experienced in a wide range of anticancer drug trials, and secure efficacy and safety data on VRN11."