Dawon Medax "Confirmed BNCT Scalability with Clinical Entry into Head and Neck Cancer"

Dawon Medax announced on the 27th that it has started treatment on the first patient in Phase 1 clinical trials for a new indication of Boron Neutron Capture Therapy (BNCT), targeting unresectable locally recurrent squamous/non-squamous cell head and neck cancer (hereinafter referred to as recurrent head and neck cancer).

Head and neck cancer refers to all malignant tumors occurring in the oral cavity, nasal cavity, tonsils, pharynx, larynx, and salivary glands. It is a cancer that is difficult to detect early due to the lack of specific symptoms and its occurrence deep in the neck, with more than half of patients diagnosed at an advanced stage and known to frequently recur. Due to the nature of the cancer's location, extensive resection is required upon recurrence; however, since this significantly reduces patients' quality of life, non-invasive treatments such as radiation therapy or drug therapy have been preferred. Nevertheless, radiation therapy is limited due to proximity to critical organs, and current drugs show only limited therapeutic effects.

According to the results of a Phase 2 clinical trial for recurrent head and neck cancer conducted by Sumitomo Heavy Industries in Japan using BNCT, excellent outcomes were observed with an objective response rate (ORR) of 71.4%, 1-year overall survival (OS) of 94.7%, 1-year progression-free survival (PFS) of 70.6%, and disease control rate (DCR) of 95.2%, while relatively low adverse events were reported. Considering that chemotherapy shows an ORR of 20-30%, this study demonstrated the superior therapeutic effect of BNCT, which led to product approval in Japan in 2020.

Yumoo Young, CEO of Dawon Medax, stated, “We possess the world’s best technology for generating neutrons suitable for treatment. You can expect better clinical results than our competitors.”

Currently, clinical trial institutions for recurrent head and neck cancer include Gachon University Gil Medical Center, The Catholic University of Korea Seoul St. Mary’s Hospital, and the National Cancer Center, which are also participating in clinical trials for recurrent high-grade glioma, with Seoul National University Hospital recently joining. The goal is to complete Phase 1 clinical trials within this year.

Meanwhile, Dawon Medax passed a technology evaluation in October last year and aims to be listed on the KOSDAQ market through a technology special listing within this year.