Dawon Medax, Clinical IND Approval for Boron Neutron Capture Therapy in Glioblastoma

[Asia Economy Reporter Jang Hyowon] Daewon Medax, a subsidiary of Daewon Sys (CEO Park Seonsun), a KOSDAQ-listed company, announced on the 1st that it received approval from the Ministry of Food and Drug Safety on the 30th for the clinical trial plan (IND) of boron neutron capture therapy (BNCT) for glioblastoma (brain tumor) in South Korea.

The clinical trial will be conducted as a Phase 1 trial to evaluate the safety, tolerability, and pharmacokinetics of BNCT in glioblastoma patients, and a Phase 2a trial to explore efficacy, at Gachon University Gil Medical Center, National Cancer Center, and Severance Hospital in Sinchon.

The boron neutron capture therapy system developed by Daewon Medax over seven years uses boron drugs and medical accelerators to selectively destroy cancer cells by particle radiation energy generated from the nuclear reaction between boron and neutrons inside cancer cells. Due to the distinctive treatment principle, it enables cell-level treatment invisible to the naked eye, minimizing damage to normal cells while achieving a high cancer cell-killing effect. In previous animal efficacy tests, BNCT demonstrated a higher tumor suppression effect compared to control groups in glioblastoma cell line U87MG and head and neck cancer cell lines SAS and FaDu.

In March 2020, Japan became the first country in the world to approve a cyclotron-based boron neutron capture therapy product, and commercial treatment for head and neck cancer is underway. In South Korea, Daewon Medax was the first to complete the development of a linear accelerator-based BNCT device at the Songdo BNCT Center and was designated as an innovative medical device by the Ministry of Food and Drug Safety in 2020.

Notably, BNCT shows excellent therapeutic effects in brain tumors, head and neck cancers, and melanoma, which are difficult to treat with current medical technologies, and is expected to improve patients' quality of life by providing high cancer treatment efficacy with a single treatment session without surgery.

CEO Yoo Mooyoung of Daewon Medax stated, "We will promptly complete the procedures to start clinical trials and ensure that the first BNCT clinical trial conducted in Korea is safe. We will strive to expand indications and offer hope to cancer patients who are difficult to treat with existing therapies."

Daewon Medax plans to submit a technology evaluation to the Korea Exchange next week for KOSDAQ listing and also plans to apply for an IND for head and neck cancer clinical trials within the second half of the year.

This content was produced with the assistance of AI translation services.