[Edaily Reporter NA EUN-KYUNG ] Voronoi, Inc.(310210)has decided to voluntarily withdraw its Canadian Clinical Trial Application (CTA) for “VRN11,” a candidate drug for non-small cell lung cancer, and to resubmit it after supplementing the data.

Voronoi, Inc. announced on the 9th that it had been notified by its contract research organization (CRO) that the application for approval of the Phase 1 and 2 clinical trial plan submitted to Health Canada had been withdrawn. The company had submitted the clinical trial plan to Canadian health authorities last August.

According to the company, this voluntary withdrawal was prompted by a request from Health Canada during the review process to update the Investigator’s Brochure (IB). Voronoi, Inc. plans to resubmit the clinical trial application after supplementing the relevant data.

VRN11 is a drug candidate currently in development for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC). Having confirmed safety and tolerability and observed early signs of efficacy in Phase 1a, Voronoi, Inc. is expanding its development to Phase 1b and 2 trials to evaluate optimal dosage and efficacy. The global target patient enrollment for these trials is 391.

Global clinical trials outside of Canada are also underway. According to the regulatory filing, the regulatory authorities that have approved the clinical trials include those in Taiwan, Australia, Singapore, Europe, Malaysia, Thailand, and Hong Kong.

Voronoi, Inc. spokesperson stated, “This voluntary withdrawal was a procedural decision made to address requests from health authorities during the review process,” adding, “We plan to resubmit the clinical trial protocol after promptly finalizing the updates to the relevant data.”