Benzinga | Jul 30, 2021 08:02AM EDT

I-Mab Reports FDA Approved Its Investigational New Drug To Initiate Phase 1 Study For Protollin For Treatment Of Alzheimer's Disease

* Planning underway for a Phase 1 Trial to assess new immunotherapy aimed at stimulating the innate immune system to clear beta amyloid protein plaques in Alzheimer's Disease

SHANGHAI and GAITHERSBURG, Md., July 30, 2021 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) submission for Protollin, an investigational drug to treat Alzheimer's disease, enabling a Phase 1 clinical trial to be initiated. Worldwide, around 50 million people are living with Alzheimer's disease or other dementias, with no cure available.



"Advancing Protollin into clinic is a critical milestone in the search to develop novel therapies for this devastating disease, and we are honored to be engaging in a planning process with partners around the globe and contributing our expertise," said Dr. Jingwu Zang, Founder, Chairman and Director of I-Mab.

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 (formerly Biodextris) 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[1]. 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.

[1] https://www.i-mabbiopharma.com/en/article-304.aspx