Voronoi announced on the 26th that it has received approval from the Ministry of Food and Drug Safety (MFDS) for the clinical trial application (IND) of VRN10, a HER2-positive solid tumor treatment, for Phase 1 clinical trials.
This approval from Korea's MFDS is the second following the IND approval from the Australian Human Research Ethics Committees (HREC) in December last year. This is expected to accelerate the progress of global clinical development.
The Phase 1 clinical trial of VRN10 will be conducted at five institutions in Korea and Australia, targeting approximately 72 patients with HER2-positive solid tumors, including breast cancer. Voronoi stated, "Since receiving the Phase 1 IND approval from the Australian Human Research Ethics Committees in December last year, patient dosing in Australia is progressing smoothly."
According to the nonclinical results presented by Voronoi at the ENA International Conference in October last year, VRN10 demonstrated high activity even against Enhertu-resistant breast cancer cells. There is currently no clear treatment for cancers resistant to Enhertu, a HER2-positive breast and gastric cancer-targeting antibody-drug conjugate (ADC), resulting in a significant unmet medical need. Additionally, VRN10 has shown excellent improvement in side effects such as diarrhea and dermatitis due to its high selectivity for HER2, and its brain penetration rate is reported to be superior compared to existing treatments.
Furthermore, VRN10 is an irreversible HER2-targeting TKI, which promotes the intracellular uptake of HER2 ADCs like Enhertu, suggesting that combination therapy with HER2 ADCs could produce synergistic therapeutic effects.
Voronoi also announced that it will present key pipeline research results, including nonclinical data of VRN10, at the 2025 American Association for Cancer Research (AACR) Annual Meeting 2025, to be held in Chicago, USA, starting from the 25th of next month.
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