Immunis Bio, a specialist company in immune cell therapy, announced on the 23rd that it has been selected as a Bio Challenger by the Ministry of Food and Drug Safety to promote the development of innovative advanced biopharmaceuticals.
The Bio Challenger program selects advanced biopharmaceuticals under development in Korea based on criteria such as ▲the first domestically developed product ▲drugs with significantly expected safety or efficacy for the target disease ▲drugs used for life-threatening or serious diseases with no treatment alternatives ▲and innovation.
The Ministry of Food and Drug Safety actively supports the entire development process through the Bio Challenger project, including setting product development goals, designing clinical trials and commercialization processes. Selected companies receive differentiated support such as expedited product commercialization and priority review during approval applications.
Immunis Bio’s NK cell therapy ’MYJ1633’ is currently undergoing Phase 2 and Phase 1/2a clinical trials targeting gastric cancer, gastrointestinal cancer, and HER-2 breast cancer, based on activation technology including high expression of activating receptors.
Kang Jeong-hwa, CEO of Immunis Bio, said, "This selection recognizes the efficacy and innovation of the NK cell therapy ‘MYJ1633’ as a next-generation immune anticancer agent," adding, "It is highly significant in increasing the possibility of orphan drug designation after Phase 2 clinical trials."
She continued, "We will be able to accelerate development including clinical trials and commercialization process design for the autoimmune disease Treg cell therapy ‘MGY1838’."
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