Voronoi Releases Clinical Data on HER2-Targeting Therapy VRN10... Tumor Shrinkage Confirmed Without Side Effects from Initial Doses
2025.10.26
■ Antitumor effect confirmed in Enhertu-refractory patients and HER2-mutant solid tumors
■ Draws attention for superior safety compared with competing drugs
Voronoi (310210, CEOs Daekwon Kim and Hyuntae Kim) announced that, following its presentation of VRN11 clinical data on the 23rd, it presented Phase 1 clinical data on VRN10 on the 25th (local time in Boston, U.S.) at the AACR-NCI-EORTC International Conference 2025, a global conference co-hosted by the American Association for Cancer Research (AACR), the National Cancer Institute (NCI), and the European Organisation for Research and Treatment of Cancer (EORTC).
VRN10 is a pipeline program in a Phase 1a clinical trial in Korea and Australia in patients with HER2 solid tumors (including breast cancer), and the data disclosed this time are initial efficacy and safety evaluation data from the 80 mg and 160 mg dose groups.
According to the presentation, tumor shrinkage was confirmed in 3 patients at the first antitumor assessment, and among them, one HER2-mutant lung cancer patient was reported to have reached complete remission in the lung lesion, the target lesion, after only 6 weeks of dosing.
<VRN10 Efficacy data>
In addition, no Grade 3 or higher drug-related adverse events have been reported to date in any patient.
<VRN10 Safety data>
Image source/data provided by: Voronoi website, Voronoi
VRN10 had previously demonstrated an antitumor effect in an Enhertu (T-Dxd) refractory model at the preclinical stage, and in this clinical trial an antitumor response was reproduced in a patient who received VRN10 after Enhertu treatment, carrying the preclinical results through into the clinic.
In particular, tumor shrinkage was observed at the first assessment in all 3 patients with HER2-mutant solid tumors, drawing attention to VRN10 as a meaningful new drug candidate in the field of HER2-mutant solid tumors, where currently approved treatment options are limited.
Daekwon Kim, CEO of R&D at Voronoi, said, "VRN10 is a meaningful drug candidate that has demonstrated an antitumor effect even in Enhertu-refractory patients, and the responses confirmed in HER2-mutant solid tumors in particular will serve as an important foundation for future clinical expansion. Unlike the safety issues such as diarrhea and hepatotoxicity reported for competing drugs, VRN10 has shown an excellent safety profile to date."
Voronoi is currently dosing at the 240 mg level, and plans to proceed with combination therapy with antibody therapeutics and ADCs (antibody-drug conjugates) based on the pharmacokinetic (PK) and pharmacodynamic (PD) analysis results of the Phase 1a trial.
■ Draws attention for superior safety compared with competing drugs
Voronoi (310210, CEOs Daekwon Kim and Hyuntae Kim) announced that, following its presentation of VRN11 clinical data on the 23rd, it presented Phase 1 clinical data on VRN10 on the 25th (local time in Boston, U.S.) at the AACR-NCI-EORTC International Conference 2025, a global conference co-hosted by the American Association for Cancer Research (AACR), the National Cancer Institute (NCI), and the European Organisation for Research and Treatment of Cancer (EORTC).
VRN10 is a pipeline program in a Phase 1a clinical trial in Korea and Australia in patients with HER2 solid tumors (including breast cancer), and the data disclosed this time are initial efficacy and safety evaluation data from the 80 mg and 160 mg dose groups.
According to the presentation, tumor shrinkage was confirmed in 3 patients at the first antitumor assessment, and among them, one HER2-mutant lung cancer patient was reported to have reached complete remission in the lung lesion, the target lesion, after only 6 weeks of dosing.
<VRN10 Efficacy data>
In addition, no Grade 3 or higher drug-related adverse events have been reported to date in any patient.
<VRN10 Safety data>
Image source/data provided by: Voronoi website, Voronoi
VRN10 had previously demonstrated an antitumor effect in an Enhertu (T-Dxd) refractory model at the preclinical stage, and in this clinical trial an antitumor response was reproduced in a patient who received VRN10 after Enhertu treatment, carrying the preclinical results through into the clinic.
In particular, tumor shrinkage was observed at the first assessment in all 3 patients with HER2-mutant solid tumors, drawing attention to VRN10 as a meaningful new drug candidate in the field of HER2-mutant solid tumors, where currently approved treatment options are limited.
Daekwon Kim, CEO of R&D at Voronoi, said, "VRN10 is a meaningful drug candidate that has demonstrated an antitumor effect even in Enhertu-refractory patients, and the responses confirmed in HER2-mutant solid tumors in particular will serve as an important foundation for future clinical expansion. Unlike the safety issues such as diarrhea and hepatotoxicity reported for competing drugs, VRN10 has shown an excellent safety profile to date."
Voronoi is currently dosing at the 240 mg level, and plans to proceed with combination therapy with antibody therapeutics and ADCs (antibody-drug conjugates) based on the pharmacokinetic (PK) and pharmacodynamic (PD) analysis results of the Phase 1a trial.