Voronoi reports positive Phase 1 results for HER2-targeted drug VRN10

Voronoi has announced Phase 1 clinical trial results for its HER2-targeted anticancer candidate, VRN10, at the ESMO Congress in Madrid. The data highlights efficacy in patients with HER2 non-TKD mutations, a group for which no approved treatments currently exist.

Among patients with evaluable HER2 mutations, a 43% partial response rate was observed in the non-TKD mutation group. Notably, all three patients with HER2-mutant non-small cell lung cancer (NSCLC) achieved a partial response. The drug also showed efficacy in patients who had previously progressed on the antibody-drug conjugate Enhertu, demonstrating anti-tumor effects even in difficult-to-treat populations.

Clinical cases also demonstrated VRN10’s ability to penetrate the blood-brain barrier, with observed reductions in brain lesions for patients with brain metastases. Regarding safety, grade 3 or higher adverse events were reported in 6% of the 50 evaluated patients, with diarrhea being the most common side effect.

Voronoi plans to determine the recommended Phase 2 dose (RP2D) and proceed with Phase 1b trials, focusing on monotherapy cohorts for HER2-mutant NSCLC and combination therapy cohorts for HER2-positive solid tumors.