[Edaily Reporter Shin Ha-yeon ] Voronoi, Inc.(310210)announced on the 4th that its Investigational New Drug (IND) application for the Phase 1b/2 clinical trial of its next-generation EGFR-targeted therapy “VRN11” has been approved by the Hong Kong Department of Health.

With this approval, Voronoi, Inc. will conduct clinical trials in Hong Kong—following its trials in Australia—for treatment-naive patients with EGFR-mutated non-small cell lung cancer. The Hong Kong trial will be led by Professor Molly Li of Prince of Wales Hospital, a leading authority in the field of EGFR-mutated non-small cell lung cancer.

According to the company, VRN11 has demonstrated efficacy and tolerability in clinical trials involving patients whose disease progressed after prior treatment. In particular, the company reported cases of intracranial complete remission (CR) in patients who developed brain metastases following treatment with third-generation EGFR inhibitors such as Tagrisso, and noted that the median intracranial progression-free survival (PFS) had not yet been reached as of the current analysis date.

Voronoi, Inc. stated that with this IND approval in Hong Kong, VRN11 will now undergo full-scale validation as a next-generation therapy with the potential to surpass existing standard treatments in the first-line treatment of EGFR-mutated lung cancer.

Voronoi, Inc. spokesperson stated, “We are smoothly expanding our Phase 1b/2 clinical trials in major countries around the world,” adding, “In addition to the countries where INDs have already been approved, we are currently undergoing the national IND approval process in South Korea, Canada, Singapore, Malaysia, Spain, and France.”