Voronoi Receives Approval for Amendment of Phase 1/2 Trial of VRN110755 in EGFR-mutant NSCLC, Expanding to Australia for Global Development
Voronoi announced on May 27, 2026, that it received approval from Taiwan's TFDA and Australia's HREC for an amendment to the Phase 1/2 clinical trial of VRN110755 for non-small cell lung cancer (NSCLC).
With this approval, Australia is added as a trial site, expanding the study to a global multi-center trial covering North America, Asia, Oceania, and Europe.
Based on safety and early efficacy signals from the Phase 1a dose-escalation, the amended trial (Phase 1b/2) aims to evaluate optimal dosing and anti-tumor activity.
The target enrollment is approximately 391 patients, with a trial duration of up to 6 years (including long-term follow-up).
Statistically, the probability of final drug approval is only about 10%, requiring investor caution.
[AI Comprehensive Analysis]The approval of the clinical trial amendment is a positive sign for global expansion of VRN110755, but it remains an early stage with a long timeline and high risk of failure. Stock volatility is likely to be driven by future clinical data rather than short-term expectations.
KOSDAQ Filing Information
Filing: [Correction of Description] Major Management Matters Related to Investment Decisions (Approval of Clinical Trial Plan Change) (Phase 1/2 Clinical Trial of VRN110755)