Planningunderwayfor 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, China and GAITHERSBURG, MD., July 30, 2021- I-Mab (the 'Company') (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, developmentand 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 drugto treat Alzheimer's disease, enabling a Phase 1 clinical trialto be initiated. Worldwide, around 50 million people are living with Alzheimer's disease or other dementias, with no cure available.
'Advancing Protollininto clinic is a critical milestone in the search to develop novel therapies for this devastating disease, and we are honoredto be engaging in a planning process with partners around the globe and contributingour expertise,' said Dr.Jingwu Zang, Founder, Chairman and Director of I-Mab.
Protollinis a new type of immunotherapy aimed at stimulating the innate immune system to activate a response against the build-upof beta amyloid protein plaques and subsequent tau tangles that cause memory loss.
Brigham and Women's Hospitaland Inspirevax(formerly Biodextris) granted I-Mab and Nhwaglobal exclusive licenses to develop, manufacture, and commercialize Protollin, and Biodextriswill manufacture and supply Protollinfor preclinical and clinical studies until the recruitment of the first patient in the Phase 1b MAD study. I-Mab will develop and commercialize Protollinoutside of the Greater China territory, while Nhwawill develop and commercialize the drug in mainland China, Hong Kong, Macau, and Taiwan.
Protollinis a novel immunotherapy aimed at stimulating the innate immune system. It is composed of outer membrane proteins of bacteria complexed with lipopolysaccharides (LPS). There are preclinical data indicating that it can modulate immune cells and has the potential to treat disorders with an immune component. Delivery of Protollinthrough nasal spray will enable the molecule reach brain and stimulate the expected immune response. The initial data support its potential application in neurodegenerative diseases such as Alzheimer's disease.
I-Mab (Nasdaq: IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon,commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transition from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facilities and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.comand follow I-Mab on LinkedIn, Twitterand WeChat.
Special Note Regarding Forward-Looking Statements
This press release includes certain disclosures which contain 'forward-looking statements.' You can identify forward-looking statements because they contain words such as 'anticipate' and 'expected.' Forward-looking statements are based on I-Mab, Jiangsu Nhwa, and Inspirevax's(formerly Biodextris)current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in filings with the U.S. Securities and Exchange Commission. I-Mab, Jiangsu Nhwa, and Inspirevax(formerly Biodextris)undertake no obligation to publicly update or revise any forward-looking statements, whether as a result ofnew information, future events or otherwise, except as may be required by law.
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I-Mab published this content on 30 July 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 July 2021 14:28:04 UTC.