[Edaily Reporter Shin Ha-yeon ] Voronoi, Inc.(310210)announced on the 18th that it has received approval from Singapore’s Health Sciences Authority (HSA) for the global Phase 1b/2 clinical trial plan (IND) for “VRN11,” its next-generation epidermal growth factor receptor (EGFR) targeted therapy for non-small cell lung cancer.

With this approval, the list of countries participating in the first-line clinical trial for treatment-naive patients with EGFR-mutated non-small cell lung cancer has expanded to include Singapore, in addition to Australia and Hong Kong.

Voronoi, Inc. is also expanding its clinical trial scope to North America. On the 7th, Voronoi, Inc. submitted an IND for the Phase 1b/2 trial of VRN11 to Health Canada.

The National Cancer Center Singapore (NCCS) and Tan Tock Seng Hospital are participating in the Singapore clinical trial. Dr. Aaron Tan, a thoracic oncologist at NCCS, and Dr. Puey Ling Chia at Tan Tock Seng Hospital will serve as the principal investigators (PIs), respectively.

VRN11 is also undergoing a Phase 1a clinical trial in patients whose disease has progressed after treatment with existing EGFR-targeted therapies. According to the company, this trial confirmed efficacy and tolerability, and demonstrated intracranial antitumor activity even in patients with brain metastases.

Voronoi, Inc. spokesperson stated, “With the approval of the IND in Singapore, we have further expanded our global clinical network for first-line treatment,” adding, “We are proceeding smoothly with the global clinical development of VRN11 by sequentially expanding clinical trials in key countries.”

The representative added, “We will continue to gather clinical data from both treatment-naive patients and those whose disease has progressed following prior treatment to demonstrate VRN11’s differentiated efficacy and safety.”