Voronoi announced on April 30 that the company has demonstrated the potential of a safe targeted anticancer therapy through early clinical data for its EGFR non-small cell lung cancer targeted therapy, VRN11, which was presented at the American Association for Cancer Research (AACR2025).
According to the Phase 1 clinical data, Voronoi reported that during the dose escalation phase of the trial, not a single drug-related adverse event of Grade 2 or higher occurred, even at doses where anticancer efficacy was confirmed. This is considered an unusual result, given that most currently approved anticancer drugs are accompanied by a certain level of serious adverse events (Grade 3 or higher).
According to the criteria of the US National Cancer Institute (NCI), Grade 2 refers to adverse events that cause some interference with daily activities but do not require hospitalization. Grade 3 indicates a serious level that causes significant disruption to daily life or requires hospitalization. In this context, VRN11 is being evaluated as demonstrating excellent safety, even in patients who have failed multiple prior treatments.
The high selectivity observed in preclinical studies, and the resulting safety, have been successfully translated into clinical data. In the preclinical stage (animal studies), VRN11 did not cause any serious adverse events even when administered at exposure levels five to seven times higher than the therapeutic dose required for complete tumor eradication, for a period of three months.
The initial Phase 1 clinical data confirm that the excellent safety profile observed in preclinical studies is maintained in human trials. It is expected that VRN11 can continue to be developed at even higher doses without serious safety issues.
The VRN11 clinical trial is about to begin dosing at 240mg, and will proceed up to 320mg, which is eight times the dose at which outstanding efficacy was observed (40mg). If dose-limiting toxicity (DLT) does not occur at 320mg, the trial is designed to allow further increases in 80mg increments.
A Voronoi representative stated, "VRN11 has not only proven to be a highly safe drug, but has also consistently demonstrated in both preclinical and clinical studies that high selectivity is an essential factor for safety."
The representative added, "VRN11 has shown the potential to become a new targeted anticancer therapy that can work effectively for non-small cell lung cancer patients without safety issues," expressing confidence that "it can make a significant contribution to improving patients' quality of life."
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