Voronoi(310210) voluntarily withdrew its application for clinical trial application (CTA) approval in Canada for the Non-small cell lung cancer (NSCLC) treatment candidate "VRN110755" about a month after filing. The move followed a request from Canadian health authorities during the review process to update the investigator's brochure (IB).
According to the Financial Supervisory Service's electronic disclosure system on the 10th, Voronoi recently voluntarily withdrew its Phase 1/2 CTA application submitted to Health Canada for VRN110755. After submitting the application on the 7th of last month, the company withdrew it upon receiving a request to update the IB during the review.
Voronoi plans to resubmit the clinical trial plan to Health Canada after supplementing the related materials. This withdrawal is limited to the Canadian CTA application.
Voronoi previously obtained approvals for protocol amendments from the Taiwan Food and Drug Administration (TFDA), the Human Research Ethics Committee (HREC) in Australia, the Department of Health (DOH) in Hong Kong, the Health Sciences Authority (HSA) in Singapore, and the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia.
VRN110755 is a therapy under development for patients with epidermal growth factor receptor (EGFR) mutations in advanced Non-small cell lung cancer (NSCLC). The global Phase 1/2 trials are designed to evaluate safety and tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity.
About 391 people will participate in the trial. Phase 1a will escalate the dose stepwise to determine the maximum tolerated dose and dose-limiting toxicity, and Phase 1b will assess efficacy and safety to set the optimal therapeutic dose to be applied in Phase 2. Phase 2 will then further evaluate efficacy and safety. The total study period, including long-term follow-up, is set at up to six years.
Voronoi said it confirmed the drug's safety and tolerability in Phase 1a and observed initial signals of efficacy, expanding the existing Phase 1 study into a Phase 1/2. After applying for a protocol amendment with Taiwanese regulators in February, the company expanded the trial scope to Australia, Hong Kong, Singapore, and Malaysia.