A novel treatment for Alzheimer’s, developed by one of Israel’s top scientists, is preparing to launch a Phase 1 clinical trial and, if successful, it could change the course of the disease and arrest its progression.
The therapy, developed by ImmunoBrain Checkpoint and based on 20 years of work by Prof. Michal Schwartz of the Weizmann Institute of Science demonstrating that the immune system is needed for the maintenance of healthy brain function and repair, would contribute to the understanding of the biology of Alzheimer’s disease.
The Phase I trial will specifically test ImmunoBrain Checkpoint’s proprietary antibody, IBC-Ab002, which is targeted to enhance the immune system and induce brain repair processes in individuals with Alzheimer’s disease. Earlier this month, the company won a $1 million grant from the Alzheimer’s Association to help get them closer to the trial.
Schwartz, who is now the company’s chief scientist, is considered one of Israel’s most renowned scientists. A recipient of the EMET Prize, she made revolutionary contributions to brain research, showing the role of the immune system in maintaining the brain’s health, and helping mitigate its dysfunction. Her studies led to her current approach of developing immunotherapies for Alzheimer’s disease and dementia that had not been considered before.
“The brain is isolated from the blood by barriers that are collectively called the blood brain barrier,” Schwartz explained. “Although the brain is the highest tissue in terms of consumption of oxygen and it is dependent on robust blood supply, there is no direct contact between the blood vessels and the brain’s tissue. Accordingly, the brain has long been considered to be isolated from the immune system.”
Since the middle of the last century, the dogma has been that immune cells are not allowed to enter the brain under any circumstances, and if they do enter, it is a sign of pathology. But Schwartz’s team challenged this dogma and broke it by discovering that there are beneficial and necessary relationships between the brain and the immune system in health and disease.
“My journey started more than 20 years ago,” she told The Jerusalem Post. “I was challenging the issue under the initial assumption that it does not make sense that the brain, the most precious and indispensable organ in our body, could not benefit from the immune system for support and repair.”
Ultimately, Schwartz discovered that cognitive performance of the brain is impaired if the immune system is compromised. Moreover, she found that in Alzheimer’s disease and dementia, the function of the immune system affects the timing of disease onset and the way it progresses, and that boosting the immune system can modify the disease.
“Through step-by-step understanding of the underlying mechanisms, we were able to propose and develop an immunotherapy that will empower the immune system to help the brain to combat Alzheimer’s disease, dementia and other diseases,” she said.
ImmunoBrain Checkpoint reached out to Schwartz and licensed her technology, moving it from the laboratory to the company.
Schwartz said that although this is only a Phase 1 study, it should prove both safety and proof of mechanism.
Currently, there are no approved therapies for Alzheimer’s disease that can modify the disease course, despite the illness plaguing so many people. According to Schwartz, as the population ages, Alzheimer’s is expected to be among the most prevalent diseases.
“There are no cures and the number of cases is going up,” she said. “And since it is not life-threatening like cancer – people live for several years not knowing their identity – it is terrible. It does not kill you, but it kills your personality and it is a burden on society.”
She recalled how when the late actor Robin Williams began developing dementia, he said that if he could not reboot his brain he would commit suicide, which is ultimately what he did.
“It is a devastating and insulting disease,” Schwartz said.
The Phase 1 trial will cost $16 million and Schwartz said that so far they have raised $4 million. The company is actively fundraising.
“It is not the best time for fundraising because of coronavirus – we have to do everything via Zoom,” she said. But she is not deterred. She said the company is submitting all of the paperwork to the Food and Drug Administration this month and they hope to be ready to start the trial in nine months. She assumes the Phase 1 trial itself will take another 10 months to a year to complete.
How long until it hits the market, if successful?
“It should not be very long, but we will know more after the Phase 1 trial,” she said.
