I-Mab Announces IND Approval by FDA to Initiate Phase 1 Study for Protollin for the Treatment of Alzheimer's Disease

Rhea-AI Summary

I-Mab (Nasdaq: IMAB) announced FDA clearance of its Investigational New Drug (IND) application for Protollin, a promising immunotherapy for Alzheimer's disease. The Phase 1 trial will assess Protollin’s ability to clear beta amyloid plaques, a hallmark of the disease. Around 50 million individuals suffer from Alzheimer's, with no current cure. Protollin is designed to stimulate the innate immune system to combat these plaques. Collaboration with Brigham and Women's Hospital and Inspirevax ensures global licensing for development and manufacturing.

Positive

• FDA clearance for Protollin's IND application enables Phase 1 clinical trial initiation.
• Protollin targets beta amyloid plaques, addressing a major cause of Alzheimer's disease.
• Collaborative global licensing agreements enhance development and commercialization prospects.

Negative

• None.

• 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

About Protollin

Protollin is 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 Protollin through 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.

About I-Mab

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.com and follow I-Mab on LinkedIn, Twitter and 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 of new information, future events or otherwise, except as may be required by law.

For more information, please contact:

I-Mab

Jielun Zhu, Chief Financial Officer
E-mail: jielun.zhu@i-mabbiopharma.com 
Office line: +86 21 6057 8000

Gigi Feng, Chief Communications Officer
E-mail: gigi.feng@i-mabbiopharma.com 
Office line: +86 21 6057 5709

Investor Inquiries:

The Piacente Group, Inc.
Emilie Wu
E-mail: emilie@thepiacentegroup.com 
Office line: + 86 21 6039 8363

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SOURCE I-Mab

FAQ

What is the significance of the FDA's IND approval for I-Mab's Protollin?

The FDA's IND approval allows I-Mab to start Phase 1 clinical trials, crucial for testing Protollin's effectiveness in treating Alzheimer's disease.

What does Protollin aim to achieve in Alzheimer's treatment?

Protollin aims to stimulate the immune system to clear beta amyloid protein plaques that are associated with Alzheimer's disease.

When does I-Mab plan to begin the Phase 1 trial for Protollin?

The Phase 1 trial for Protollin is set to begin following FDA clearance, with patient recruitment for the study anticipated shortly.

Who are I-Mab's partners in the development of Protollin?

I-Mab collaborates with Brigham and Women's Hospital and Inspirevax, which provide global exclusive licenses for Protollin's development.

How many people are affected by Alzheimer's disease globally?

Approximately 50 million people globally live with Alzheimer's disease or other dementias.