(Health Korea News / Lee Soon-ho) Immune Bio, a company specializing in immune cell therapy, announced on the 23rd that its NK cell therapy ‘MYJ1633’, which it is developing, was selected as a Bio Challenger by the Ministry of Food and Drug Safety to promote the development of innovative, advanced biopharmaceuticals.
According to the company, BioChallenger is selected based on the following criteria: ▲products developed for the first time in Korea among cutting-edge biopharmaceuticals under development in Korea ▲medicines with significant safety or efficacy expectations for target diseases ▲medicines used for patients with life-threatening or serious diseases for which there are no alternative treatments ▲innovation.
Through the Bio Challenger Project, the Ministry of Food and Drug Safety actively participates in the entire development process, including setting product development goals, clinical trials, and designing commercialization processes, to provide practical support for product development. Companies selected for this project receive differentiated support, such as support for rapid product development and priority review when applying for approval.
The NK cell therapy ‘MYJ1633’ of ImmuneSbio, which was selected this time, is currently undergoing phase 2 clinical trials and phase 1/2a clinical trials targeting gastric cancer, gastrointestinal cancer, and HER-2 breast cancer based on technology such as high expression of activating receptors.
ImmunisBio CEO Kang Jeong-hwa said, “With this selection, ‘MYJ1633’ has been recognized for its value as a next-generation immune anticancer drug in terms of efficacy and innovation, and has increased the possibility of being designated as an orphan drug after phase 2 clinical trials.” He added, “We will now be able to accelerate development, including clinical trials and commercialization process design for ‘MGY1838,’ a Treg cell therapy for autoimmune diseases.”
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Source: www.hkn24.com
