Voronoi has expanded the global clinical trial for its lung cancer treatment candidate 'VRN110755' to Europe.

On the 22nd, Voronoi announced through a corrective disclosure that it has added the European Medicines Agency (EMA) as an approval authority for the Phase 1/2 clinical trial of VRN110755. This reflects the EU Clinical Trial Application (CTA) submission in the previously disclosed application for approval of clinical trial plan amendments on June 10.

According to the company, on June 19, it received notification from its Contract Research Organization (CRO) that the EU CTA submission to the EMA had been completed. The key details of the clinical trial plan remain the same as previously disclosed.

Accordingly, the number of regulatory authorities to which the VRN110755 clinical trial plan has been submitted has expanded to a total of four:

• Taiwan Food and Drug Administration (TFDA)
• Australia Human Research Ethics Committee (HREC)
• Singapore Health Sciences Authority (HSA)
• European Medicines Agency (EMA)

The clinical trial will be conducted across North America, Asia, Oceania, and Europe.

Phase 1/2 Trial Enrolling 391 Patients... Up to 6 Years of Follow-Up

VRN110755 is a global Phase 1/2 clinical trial evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy in patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC). The trial will enroll a total of 391 patients and consists of dose-escalation and dose-expansion phases.

• Phase 1a: Determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT)
• Phase 1b: Confirm the optimal dose for Phase 2
• Phase 2: Additional evaluation of efficacy and safety

The clinical trial period, including long-term follow-up, is up to 6 years.

Voronoi explained that as safety and tolerability were confirmed and early efficacy signals were observed in Phase 1a, it applied for an amendment approval to expand into Phase 1b/2 to evaluate the optimal dose and efficacy in the target patient population.

The company also plans to apply for amendment approvals in South Korea, Hong Kong, and Australia, where the clinical trial plan was previously approved. The company added that it will promptly disclose any significant developments regarding the EU CTA review results and approval status.