Voronoi Applies for Phase 1 Clinical Trial of Lung Cancer Treatment 'VRN11'

Voronoi announced on the 28th that it has submitted an Investigational New Drug (IND) application for the Phase 1 clinical trial of the non-small cell lung cancer (NSCLC) treatment 'VRN11' to the Ministry of Food and Drug Safety.

This clinical trial will be conducted to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of VRN11 in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer. It will involve about 50 NSCLC patients across more than 10 institutions in Korea, the United States, and Taiwan. In addition to safety assessments such as adverse reactions in patients, efficacy indicators including objective response rate (ORR), progression-free survival (PFS), and intracranial response rate will also be evaluated.

In particular, this clinical trial aims to confirm the therapeutic effect of VRN11 on NSCLC patients with the EGFR C797S mutation, which arises due to resistance to existing drug treatments for EGFR mutant NSCLC. VRN11 demonstrated 100% brain penetration in preclinical studies, raising expectations that it will be effective in treating brain metastases, which affect about half of EGFR NSCLC patients.

Daegwon Kim, Head of Research at Voronoi, stated, "VRN11 shows strong activity not only against EGFR C797S but also against primary tumors, so we expect an expansion of indications. We hope that the clinical success of VRN11 will help EGFR mutant NSCLC patients to be relieved from their suffering as soon as possible."

Meanwhile, Voronoi plans to disclose preclinical data of VRN11 at the IASLC WCLC 2023, the World Conference on Lung Cancer, to be held in Singapore this September.

This content was produced with the assistance of AI translation services.