Voronoi Releases 'VRN10' Clinical Data at AACR 2026... Presents New Possibilities for HER2 Treatment
2026.04.20
■ Differentiated 'HER2 degradation' mechanism elucidated... Rising expectations for combination synergy with ADCs such as Enhertu
■ Phase 1b/2 dose-optimization trials of VRN10 monotherapy and in combination with Enhertu planned within the year
Voronoi (310210, CEOs Daekwon Kim and Hyuntae Kim) announced that on the 17th (local time) it presented the mechanism of action and Phase 1 clinical data of VRN10, its HER2 solid tumor targeted therapy, at the American Association for Cancer Research Annual Meeting (AACR 2026). The presentation included VRN10's differentiated mechanism of action on HER2, along with the results of a correlation analysis between PK (pharmacokinetics, drug exposure), PD (pharmacodynamics, biomarkers), and tumor response in Phase 1 patients.
The core of the presentation is VRN10's unique mechanism of action. VRN10 was confirmed not merely to inhibit the tumor proliferation signaling of the HER2 protein, but also to strongly induce the internalization and degradation of the HER2 protein.
In particular, when VRN10 is combined with Enhertu, the process by which the HER2/Enhertu complex is degraded by lysosomes within the cell is promoted, which was confirmed to increase the release of Enhertu's payload (DXd), which induces cancer cell death. This mechanism is regarded as a strength that clearly differentiates VRN10 from existing competing drugs such as tucatinib (Tukysa), zongertinib (Hernexeos), and sevabertinib (Hyrnuo).
Voronoi views this conference as an opportunity to enhance the clinical value of VRN10 by elucidating the correlation between PK, PD, and tumor response based on blood data from patients dosed with VRN10. By measuring the concentration of VRN10 in patients' blood, treating HER2-positive breast cancer cells with those blood samples, and analyzing the degree of signaling inhibition, the company demonstrated a clear positive correlation between this indicator and the actual degree of tumor shrinkage, thereby securing both the clinical efficacy and the predictability of VRN10.
Voronoi is currently proceeding with dose escalation of VRN10 to 480 mg, and the data obtained are expected to serve as key indicators for accelerating the clinical trials to come.
Image source: Voronoi (AACR 2026)
A Voronoi representative said, "Through this AACR, we have demonstrated VRN10's differentiated mechanism and clinical potential to the global market. Based on the analysis results obtained, we plan to simultaneously initiate within the year Phase 1b/2 dose-optimization trials for both monotherapy in HER2-mutant patients and combination therapy with Enhertu in patients with HER2-positive solid tumors."
■ Phase 1b/2 dose-optimization trials of VRN10 monotherapy and in combination with Enhertu planned within the year
Voronoi (310210, CEOs Daekwon Kim and Hyuntae Kim) announced that on the 17th (local time) it presented the mechanism of action and Phase 1 clinical data of VRN10, its HER2 solid tumor targeted therapy, at the American Association for Cancer Research Annual Meeting (AACR 2026). The presentation included VRN10's differentiated mechanism of action on HER2, along with the results of a correlation analysis between PK (pharmacokinetics, drug exposure), PD (pharmacodynamics, biomarkers), and tumor response in Phase 1 patients.
The core of the presentation is VRN10's unique mechanism of action. VRN10 was confirmed not merely to inhibit the tumor proliferation signaling of the HER2 protein, but also to strongly induce the internalization and degradation of the HER2 protein.
In particular, when VRN10 is combined with Enhertu, the process by which the HER2/Enhertu complex is degraded by lysosomes within the cell is promoted, which was confirmed to increase the release of Enhertu's payload (DXd), which induces cancer cell death. This mechanism is regarded as a strength that clearly differentiates VRN10 from existing competing drugs such as tucatinib (Tukysa), zongertinib (Hernexeos), and sevabertinib (Hyrnuo).
Voronoi views this conference as an opportunity to enhance the clinical value of VRN10 by elucidating the correlation between PK, PD, and tumor response based on blood data from patients dosed with VRN10. By measuring the concentration of VRN10 in patients' blood, treating HER2-positive breast cancer cells with those blood samples, and analyzing the degree of signaling inhibition, the company demonstrated a clear positive correlation between this indicator and the actual degree of tumor shrinkage, thereby securing both the clinical efficacy and the predictability of VRN10.
Voronoi is currently proceeding with dose escalation of VRN10 to 480 mg, and the data obtained are expected to serve as key indicators for accelerating the clinical trials to come.
Image source: Voronoi (AACR 2026)
A Voronoi representative said, "Through this AACR, we have demonstrated VRN10's differentiated mechanism and clinical potential to the global market. Based on the analysis results obtained, we plan to simultaneously initiate within the year Phase 1b/2 dose-optimization trials for both monotherapy in HER2-mutant patients and combination therapy with Enhertu in patients with HER2-positive solid tumors."