The U.S. Food and Drug Administration has cleared the Investigational New Drug submission for Protollin, an investigational drug to treat Alzheimer's disease, enabling a Phase 1 clinical trial to be initiated, I-Mab (IMAB) said in a statement.
Protollin is a new type of immunotherapy aimed at stimulating the innate immune system to activate a response against the build-up of beta amyloid protein plaques and subsequent tau tangles that cause memory loss.
Brigham and Women's Hospital and Inspirevax granted I-Mab and Nhwa global exclusive licenses to develop, manufacture, and commercialize Protollin, and Biodextris will manufacture and supply Protollin for preclinical and clinical studies until the recruitment of the first patient in the Phase 1b MAD study.
I-Mab will develop and commercialize Protollin outside of the Greater China territory, while Nhwa will develop and commercialize the drug in mainland China, Hong Kong, Macau, and Taiwan.
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