Voronoi Releases 'VRN10' Phase 1 Data at SABCS 2025... "Antitumor Effect Confirmed from Initial Doses"
2025.12.12
■ 'Zero' cases of Grade 3 or higher toxicity up to the 240 mg dose group... Outstanding safety and early efficacy demonstrated
■ Unique 'HER2 degradation' mechanism elucidated... Rising expectations for combination synergy with ADCs such as Enhertu
Voronoi (310210, CEOs Daekwon Kim and Hyuntae Kim) announced that it presented the latest Phase 1 clinical results of VRN10, its HER2 solid tumor targeted therapy, on the 11th (local time) at the San Antonio Breast Cancer Symposium (SABCS 2025), held in the U.S. from December 9 to 12.
The Phase 1 clinical trial of VRN10 is under way in Korea and Australia in patients with HER2-positive or HER2-mutant solid tumors, and this presentation included data up to the 240 mg dose group, following the 80 mg and 160 mg dose data disclosed at the recent 'AACR-NCI-EORTC 2025.'
According to the presentation, VRN10 showed a remarkable antitumor effect despite the early doses. Tumor shrinkage was confirmed in 3 patients among the initial dose groups of 80 to 160 mg, and one of them achieved a partial response, with tumor size reduced by 30% or more. In particular, a HER2-mutant breast cancer patient who was refractory to existing therapies including Enhertu (trastuzumab deruxtecan) and whose tumor had progressed also showed tumor shrinkage of around -30%, demonstrating broad therapeutic potential.
Along with outstanding efficacy, excellent safety was also confirmed. A total of 12 patients have been dosed so far up to the 240 mg dose, and not a single Grade 3 or higher drug-related serious adverse event has been reported among them.
Voronoi cited VRN10's differentiated drug mechanism as the basis for these results. According to the non-clinical data disclosed at the symposium, unlike existing competing drugs such as tucatinib (Tukysa), zongertinib (Hernexeos), and sevabertinib (Hyrnuo), VRN10 not only inhibits HER2 signaling but also has a structure-specific mechanism that induces the internalization and degradation of HER2 on the surface of cancer cells.
Thanks to this mechanistic superiority, efficacy can be expected even in HER2-mutant cancers where a therapeutic effect was difficult to expect from existing HER2 tyrosine kinase inhibitors (HER2 TKIs) alone, and non-clinical data further confirmed that it can also produce high synergy when co-administered with ADC (antibody-drug conjugate) therapies such as Enhertu.
A Voronoi representative said, "Dose escalation to 320 mg is currently under way. Based on the pharmacokinetic (PK) and pharmacodynamic (PD) analysis results obtained, we plan to pursue not only monotherapy trials in HER2-mutant patients but also combination clinical development with existing antibody therapeutics and ADCs in patients with HER2-positive solid tumors."
■ Unique 'HER2 degradation' mechanism elucidated... Rising expectations for combination synergy with ADCs such as Enhertu
Voronoi (310210, CEOs Daekwon Kim and Hyuntae Kim) announced that it presented the latest Phase 1 clinical results of VRN10, its HER2 solid tumor targeted therapy, on the 11th (local time) at the San Antonio Breast Cancer Symposium (SABCS 2025), held in the U.S. from December 9 to 12.
The Phase 1 clinical trial of VRN10 is under way in Korea and Australia in patients with HER2-positive or HER2-mutant solid tumors, and this presentation included data up to the 240 mg dose group, following the 80 mg and 160 mg dose data disclosed at the recent 'AACR-NCI-EORTC 2025.'
According to the presentation, VRN10 showed a remarkable antitumor effect despite the early doses. Tumor shrinkage was confirmed in 3 patients among the initial dose groups of 80 to 160 mg, and one of them achieved a partial response, with tumor size reduced by 30% or more. In particular, a HER2-mutant breast cancer patient who was refractory to existing therapies including Enhertu (trastuzumab deruxtecan) and whose tumor had progressed also showed tumor shrinkage of around -30%, demonstrating broad therapeutic potential.
Along with outstanding efficacy, excellent safety was also confirmed. A total of 12 patients have been dosed so far up to the 240 mg dose, and not a single Grade 3 or higher drug-related serious adverse event has been reported among them.
Voronoi cited VRN10's differentiated drug mechanism as the basis for these results. According to the non-clinical data disclosed at the symposium, unlike existing competing drugs such as tucatinib (Tukysa), zongertinib (Hernexeos), and sevabertinib (Hyrnuo), VRN10 not only inhibits HER2 signaling but also has a structure-specific mechanism that induces the internalization and degradation of HER2 on the surface of cancer cells.
Thanks to this mechanistic superiority, efficacy can be expected even in HER2-mutant cancers where a therapeutic effect was difficult to expect from existing HER2 tyrosine kinase inhibitors (HER2 TKIs) alone, and non-clinical data further confirmed that it can also produce high synergy when co-administered with ADC (antibody-drug conjugate) therapies such as Enhertu.
A Voronoi representative said, "Dose escalation to 320 mg is currently under way. Based on the pharmacokinetic (PK) and pharmacodynamic (PD) analysis results obtained, we plan to pursue not only monotherapy trials in HER2-mutant patients but also combination clinical development with existing antibody therapeutics and ADCs in patients with HER2-positive solid tumors."