VRN10 / Voronoi - LARVOL DELTA

Preclinical and Clinical Activity of VRN101099, a Novel Covalent HER2 TKI for Metastatic HER2-Driven Solid Tumors (AACR-NCI-EORTC 2025) - "Although HER2-targeted therapies such as T-DXd and Zongertinib have demonstrated favorable outcomes in HER2-driven tumors, their efficacy remains limited, particularly in patients with brain metastasis and in those harboring specific activating mutations (e.g. S310F/Y). Pharmacokinetic analysis showed that VRN10 achieves sufficient target engagement at an 80mg Ctrough, and remains well tolerated up to 160mg, with no treatment-related adverse events (TRAEs). Together, preclinical and emerging clinical findings demonstrate VRN101099's promise as a therapeutic option for patients with HER2-positive or HER2-mutant solid tumors, including those with difficult-to-treat metastatic sites such as the brain and bone."

Late-breaking abstract • Metastases • Preclinical • Bladder Cancer • Brain Cancer • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pancreatic Cancer • Solid Tumor • HER-2

Voronoi confirms tumor reduction in all phase 1 VRN10 patients (Chosun Biz) - "In the phase 1a results, tumor reduction was confirmed in three patients at the first antitumor assessment, and among them, a patient with HER2-mutant lung cancer achieved a complete response in the target lung lesion six weeks after dosing. In addition, no serious drug-related adverse events have been reported in any patient to date."

P1 data • Lung Cancer • Solid Tumor • HER-2

Voronoi, HER2-positive solid tumor treatment 'VRN10' phase 1 clinical trial plan application [Google translation] (Money Today) - "Voronoi announced on the 29th that it has applied for approval of a phase 1 clinical trial plan (IND) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of the new drug candidate 'VRN10' for patients with HER2-positive and mutant solid cancer. The phase 1 clinical trial of VRN10 is scheduled to be conducted in five institutions in Korea and Australia with approximately 70 patients with solid cancer, including HER2-positive breast cancer. In the phase 1 clinical trial, not only safety such as adverse reactions of patients but also efficacy indicators such as objective response rate (ORR), progression-free survival (PFS), and intracranial response rate will be evaluated."

New P1 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Voronoi, stock price soars on expectations for new lung cancer drug… Market cap exceeds 2 trillion [Google translation] (Money Today) - "Voronoi is also preparing for the clinical trial of 'VRN10', a breast cancer treatment pipeline targeting HER2 (human epidermal growth factor receptor 2). It is a substance with higher blood-brain barrier permeability than existing treatments, and it was explained that it shows relatively high activity against resistant mutations caused by taking existing treatments. It plans to submit a phase 1 clinical trial plan (IND) within the year."

New trial • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

Voronoi approves phase 1 clinical trial plan for lung cancer new drug candidate in Taiwan [Google translation] (HIT News) - "In addition, the company plans to apply for IND approval in the second half of this year for 'VRN10', which specifically binds to HER2-positive protein, which is the cause of various solid cancers such as breast cancer, and penetrates the blood-brain barrier."

New trial • Oncology • Solid Tumor

Voronoi participates in Amgen Networking Day…“High interest from global big pharma companies such as VRN11” (Sedaily) - "Voronoi announced on the 18th that he was invited to a networking event hosted by the Ministry of Health and Welfare and co-hosted by the Korea Health Industry Development Institute and Amgen Korea and held at the Seoul Health Industry Promotion Agency Innovation and Startup Center on the 14th. At the event attended by Amgen's R&D and business development (BD) senior executives, Voronoi announced the development of new drugs based on artificial intelligence (AI) along with core pipelines such as VRN11, an EGFR mutation inhibitor for non-small cell lung cancer, and VRN10, a breast cancer HER2-positive protein inhibitor."

Clinical • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Voronoi paid-in capital increase success…KRW 61.3 billion will be spent on clinical trials for new lung cancer drugs [Google translation] (News1 Korea) - "Voronoi (310210)'s paid-in capital increase through shareholder allocation was a box office success, achieving better-than-expected results. The amount of financing increased from KRW 45 billion to KRW 61.3 billion as the issuance price of new shares increased...With funding secured, the development of 'VRN11', a new drug candidate for EGFR C797S mutated non-small cell lung cancer, and 'VRN10', a new drug candidate for HER2 mutated breast cancer, is expected to proceed until 2025...Voronoi plans to conduct phase 1 clinical trials of VRN11 in the second half of this year....The VRN10 phase 1a clinical trial is expected to be conducted on a total of 21 people in Korea."

Financing • New P1 trial • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2