Brigham and Women’s Hospital Initiates First Clinical Trial of Nasal Vaccine for Alzheimer’s Disease

The first human trial of a nasal vaccine for Alzheimer’s Disease (AD) is due to begin at Brigham and Women’s Hospital. The Phase 1 trial will test the safety and efficacy of the new shot to prevent or halt the progression of the neurodegenerative disease.

The launch is the culmination of nearly two decades of research led by Howard Wiener, co-director of the Ann Romney Center for Neurological Diseases at Brigham.

“The launch of the first human trial of a nasal vaccine for Alzheimer’s is a remarkable milestone,” said Weiner. “Over the last two decades, we’ve amassed preclinical evidence suggesting the potential of this nasal vaccine for AD.”

According to Weiner, if the clinical trials succeed, the vaccine could become a non-toxic treatment for AD and could also be given as an early prevention measure for those at risk of the disease.

A Vaccine that Activates the Immune System 

The vaccine uses Protollin, an immune modulator and investigational intranasal agent that activates the immune system to clear beta-amyloid, a hallmark of AD. Made of bacteria-based proteins, Protollin has been safely used as an adjuvant in other vaccines.

Following its delivery via the nasal route, Protollin travels to the lymph nodes on the sides and back of the neck and activates the white blood cells there. The activated immune cells would migrate to the brain and trigger clearance of beta-amyloid plaques.

“For 20 years, there has been growing evidence that the immune system plays a key role in eliminating beta-amyloid. This vaccine harnesses a novel arm of the immune system to treat AD,” said Tanuja Chitnis, MD, professor of Neurology at the Brigham and principal investigator of the trial. “Research in this area has paved the way for us to pursue a whole new avenue for potentially treating not only AD but also other neurodegenerative diseases.”

The Phase 1 trial will be a single ascending dose (SAD) trial involving 16 participants enrolled from the Ann Romney Center. These participants are expected to be 60 to 85 years of age with early signs and symptoms of AD and test positive for amyloid. Two doses of the vaccine will be given a week apart.

The trial will mainly test the vaccine for safety and tolerability, while the researchers will also check how Protollin affects the immune response, namely in the white blood cells.

Co-Developed by I-Mab and NHWA 

Protollin is licensed from Brigham and Inspirevax to I-Mab and Jiangsu Nhwa Pharmaceutical (NHWA) for development, manufacture, and commercialization. I-Mab has the rights to Protollin outside the Greater China territory, while NHWA has the rights to the drug in mainland China, Hong Kong, Macau, and Taiwan. The two companies are also funding the clinical trials of the nasal vaccine.

“We are thrilled to see Protollin approved to advance into clinical trials after many years of pioneering work, and we are honored to contribute our expertise in the global effort to develop novel therapies for this devastating disease,” said Dr. Jingwu Zang, founder, chairman, and director of I-Mab.

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Joy Lin

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