Voronoi announced that it has voluntarily withdrawn its Phase 1/2 clinical trial application to Health Canada (HC) for 'VRN110755', which is being developed as a treatment for non-small cell lung cancer.

■ Reason and Background of the Voluntary Withdrawal According to the regulatory filing, the voluntary withdrawal came in response to a request from Canadian health authorities during the review process to update the Investigator's Brochure (IB).

The company submitted an application for voluntary withdrawal of the clinical trial plan approval to Health Canada on September 8, local Canadian time, or September 9, Korean time. It was then notified by its CRO on September 9 that the withdrawal of the clinical trial plan approval application to Health Canada had been completed. Voronoi had previously submitted the clinical trial plan approval application to Health Canada on August 7.

■ Overview of the Clinical Trial The trial is a global Phase 1/2 study evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic properties, and anti-tumor efficacy of VRN110755 in patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR mutations. The target number of participants is 391, and the trial duration, including long-term follow-up, is up to 6 years.

■ No Changes to Trials in Other Countries The company stated that there are no changes to the ongoing clinical trials approved by Taiwan Food and Drug Administration (TFDA), Australia's Human Research Ethics Committee (HREC), Hong Kong Department of Health (DOH), Singapore Health Sciences Authority (HSA), and Malaysia's National Pharmaceutical Regulatory Agency (NPRA).