FDA OKs Phase 1 Trial of Nasal Spray Immunotherapy Protollin

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by Patricia Inacio, PhD |

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I-Mab will launch a Phase 1 clinical trial evaluating Protollin, its nasal spray immunotherapy candidate for Alzheimer’s disease.

The biotech company’s announcement follows the recent approval of an investigational new drug (IND) application for Protollin by the U.S. Food and Drug Administration (FDA).

“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,” Jingwu Zang, MD, PhD, founder, chairman and director of I-Mab, said in a press release.

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Alzheimer’s Disease, Clinical Trials, and You

The presence of abnormal clumps of beta-amyloid and tau protein tangles in the brain are two hallmarks of Alzheimer’s, causing a disruption in the communication between nerve cells and ultimately the problematic symptoms associated with the neurodegenerative disease.

As such, therapies that prevent or lessen the buildup of beta-amyloid protein plaques and subsequent tau tangles may help prevent disease progression.

Protollin is a new intranasal immunotherapy made of proteins derived from the outer membrane of certain bacteria. It works by stimulating the innate immune system — the part of the immune system that serves as the body’s first line of defense — to clear amyloid-beta plaques and tau tangles from the brain.

The therapy is delivered as a nasal spray that enables it to reach the brain, where it can mount the necessary immune response.

No further information was given as to when the clinical trial might start.

Previous preclinical studies have shown that nasal administration of Protollin activated a type of brain immune cells, called microglia, and prevented the accumulation of beta-amyloid plaques in young mice. Moreover, the immunotherapy candidate decreased beta-amyloid accumulation and improved memory function in an old mouse model of Alzheimer’s.

I-Mab and Jiangsu Nhwa Pharmaceutical (Nhwa) entered an agreement in 2019 for exclusive licenses to develop, manufacture, and commercialize Protollin. The deal was made with the therapy’s original developers, researchers at the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, in Boston, and Inspirevax (formerly Biodextris).

Nhwa will develop and commercialize the immunotherapy in China, Hong Kong, Macau, and Taiwan, while I-Mab is responsible for the treatment’s development and commercialization in the rest of the world.