Eutilex, a Korean biotechnology company that develops CAR-T therapy for liver tumors, including hepatocellular carcinoma (HCC), has been selected as a "BioChallenger" in 2024 by the National Institute of Food and Drug Safety Evaluation (NIFDS).
The BioChallenger program, a government-funded initiative, seeks to advance the development of cutting-edge biopharmaceuticals to meet unmet medical needs. Launched in 2020, it is overseen by the Ministry of Food and Drug Safety (MFDS) as part of a pilot project designed to accelerate the commercialization of innovative biopharmaceuticals developed domestically.
The project's selection criteria include products that will be the first of their kind to be developed in Korea; medicines used to treat life-threatening or serious diseases and patients with no treatment alternatives; medicines with significant expectations of safety or efficacy for the target disease based on non-clinical data; and demonstrate innovation in technology, indications, or treatment areas.
EU307, a CAR-T therapy for HCC, targets the glypican-3 (GPC3) cancer antigen specifically overexpressed in HCC without impacting normal liver cells. The therapy also aims to boost CAR-T cell function and improve the tumor microenvironment through interleukin-18 (IL-18) secretion. EU307 received Investigational New Drug (IND) approval in Korea in February 2023 and is currently in phase 1 clinical trials.
The BioChallenger program provides critical commercialization support, including dedicated reviewers' consultations on quality, safety, and efficacy.
“Being selected for the BioChallenger is another recognition of the value of EU307,” said Choi Yun, executive vice president of cell gene therapy (CGT) at Eutilex. “This support project will help us prepare for the commercialization of EU307.”
In addition, EU307 has been accepted for clinical design at the European Society for Medical Oncology (ESMO) 2024, which will be held September 13-17 in Barcelona, Spain.
On the news of the BioChallenger designation, Eutilex shares jumped 11.05 percent to 2,865 won at 1:57 p.m. on Monday.