Voronoi has drawn attention by voluntarily withdrawing its IND application for the non-small cell lung cancer (NSCLC) treatment candidate, VRN110755, from the U.S. FDA just a month after submission.

Voronoi announced on the 15th that it had withdrawn the IND application for Phase 1a/b trials of VRN110755 on July 13. The application was initially submitted on June 20.

The clinical trial was designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor efficacy of VRN110755 in patients with advanced NSCLC who have EGFR mutations. 

The trial was set to proceed in two stages: a dose-escalation Phase 1a to determine the maximum tolerated dose and dose-limiting toxicity, and a dose-expansion Phase 1b to establish the optimal therapeutic dose based on efficacy and safety.

Voronoi explained that the voluntary withdrawal was due to differences in dose escalation plans between the U.S. FDA and the ongoing trials in Korea and Taiwan. The FDA recommended more dose levels for Phase 1a than those being tested in Korea and Taiwan, which would slow the overall trial progress. 

As a result, Voronoi decided to withdraw the U.S. application to focus on speeding up the trials in Korea and Taiwan, with plans to resubmit the IND to the FDA once the optimal dose is confirmed.

A company representative stated, "We are currently escalating doses in the Phase 1a trials in Korea and Taiwan, with increases of 100%, 100%, 100%, and 50%. In contrast, the FDA recommended dose increases of 100%, 67%, 50%, and 33%, based on the Fibonacci model. To avoid delays in the overall trial progress, we made the decision to withdraw the U.S. application."