Abion Applies for IND of Glioblastoma Treatment "Expanding Indications... Strengthening Negotiation Power for Technology Transfer"

ABION announced on the 6th that it has submitted an Investigational New Drug (IND) application for the Phase 2 clinical trial of 'Vabametkib (ABN401)', a treatment for glioblastoma (GBM), to the Ministry of Food and Drug Safety.

This clinical trial will be conducted as an Investigator-Initiated Trial (IIT). Through independent research led by investigators, the company expects to secure meaningful data that can be utilized in establishing a technology transfer strategy.

The trial targets 26 patients with high-grade glioma (HGG) accompanied by mesenchymal-epithelial transition (MET) gene alterations. According to the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria, the objective response rate (ORR) will be evaluated when Vabametkib is administered to HGG patients with MET gene alterations.

Glioblastoma is the most malignant grade 4 HGG originating from glial cells, characterized by rapid growth that can cause headaches, nausea, vomiting, and seizures due to increased intracranial pressure. Additionally, symptoms such as motor and sensory deficits, limb paralysis, and cognitive decline may occur due to tumor and brain edema. The average survival period is less than 2 years, with a 5-year survival rate below 10%, and more than 90% of patients experience recurrence after treatment, making it a highly malignant brain tumor with a very poor prognosis.

The company stated, "Based on Vabametkib's high selectivity and low side effects, it is highly likely to be an effective treatment option for glioblastoma patients with MET gene mutations," adding, "Since the approval of temozolomide, the first-line standard treatment for glioblastoma, no new drugs have been developed for over 20 years, so expanding Vabametkib's indications will strengthen our negotiating power for technology transfer."