Voronoi announced on the 7th that it has corrected its previous regulatory filing to reflect the completion of an Investigational New Drug (IND) application amendment submitted to Health Canada (HC) regarding the global Phase 1/2 clinical trial of 'VRN110755,' a drug candidate for the treatment of EGFR-mutant non-small cell lung cancer (NSCLC).

This correction was an action taken to add information about the Canadian clinical trial application that was omitted from the "Major Management Matters Related to Investment Decisions" disclosure published on July 8. The company stated that on August 7, 2026, it received notification from its CRO (Contract Research Organization) that the Phase 1/2 clinical trial application had been submitted to Health Canada.

As a result, Health Canada has been newly added to the list of regulatory authorities where global clinical trial applications for VRN110755 have been filed. This is in addition to the existing seven countries and regions: Taiwan Food and Drug Administration (TFDA), Australian Human Research Ethics Committee (HREC), Health Sciences Authority (HSA) of Singapore, European Medicines Agency (EMA), National Pharmaceutical Regulatory Agency (NPRA) of Malaysia, FDA Thailand, and Department of Health (DOH) of Hong Kong.

VRN110755 is currently undergoing a global Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy in patients with EGFR-mutant advanced non-small cell lung cancer. The trial will be conducted at multiple institutions across regions including North America, Asia, Oceania, and Europe. It targets a total of 391 subjects, with a maximum trial duration of six years, including long-term follow-up.

Voronoi stated that the key details of this Canadian clinical trial application are the same as those in the previous disclosure. The company also added that it plans to make an immediate public disclosure as soon as the relevant procedures are completed, should it receive clinical trial approval from Health Canada in the future.