ADELAIDE, South Australia—As South Australia’s Flinders University notes, “With more than 7.5 million new cases of Alzheimer’s disease (AD) a year, the race to find a vaccine and effective treatment for dementia is growing by the day.” And with more than 48 million dementia cases in 2015, the university adds, it is emerging as one of the biggest costs to the world’s healthcare systems, especially in mature economies in western countries.
So, what to do about it? Well, for starters, don’t go it alone. Flinders University experts teamed up a U.S. research team composed of scientists at the Institute of Molecular Medicine (IMM) and the University of California, Irvine (UCI), to create a vaccine formulation that targets the abnormal beta-amyloid and tau proteins that are associated with AD. The results of this work were published in the journal Scientific Reports recently.
“If we are successful in preclinical trials, in three to five years we could be well on the way to one of the most important developments in recent medical history,” according to Prof. Nikolai Petrovsky of the Flinders University School of Medicine, who also is director of South Australian vaccine research company Vaxine Pty Ltd., an Australian biotech company focusing on development of innovative vaccine technologies.
“Along with our rapidly aging populations, we now know that the explosion in type 2 diabetes in the West is likely to further dramatically fuel the projected rise in the number of cases of dementia globally, with diabetes being the major risk factor for Alzheimer’s disease,” Petrovsky added.
The quest to develop treatments—or better yet, a cure—for AD is costly and lengthy, notes Flinders University, pointing out that in the decade leading up to 2012, 244 compounds were investigated in 413 clinical trials around the world, with only one new drug being approved for temporarily alleviating symptoms of the disease—a success rate of 0.4 percent.
While it isn’t a shoe-in yet to help raise that figure, U.S. researchers, with funding from the National Institutes of Health and the Alzheimer’s Association, developed an “exceptional” universal vaccine platform, called MultiTEP, to target aberrant beta-amyloid and tau proteins.
Using a combination of anti-amyloid-beta and anti-tau vaccines with “powerful and safe” adjuvant technology called Advax developed by Vaxine “shows promise for both preventive and therapeutic approaches in AD,” Prof. David Cribbs of the UCI Institute for Memory Impairments and Neurological Disorders told Bloomberg news.
The Advax adjuvant could be important, note the authors of the recent paper, who wrote, “Importantly, a pandemic influenza vaccine formulated with Advax was effective in human subjects up to 90 years of age, enhancing anti-influenza plasmablast and antibody responses across the whole age spectrum. The ability of this delta-inulin based adjuvant to help counter the normal age-related decline in plasmablast and antibody responses to influenza immunization is likely to be important for human AD vaccine development, as these will principally need to be administered to elderly subjects with immuno-senescence.”
Prof. Michael Agadjanyan, head of IMM’s Department of Molecular Immunology, has noted that the MultiTEP platform-based vaccines “do not induce potentially harmful auto-reactive cellular immune responses, while still generating antibodies that bind strongly to the amyloid and tau pathological molecules in brain tissue from AD patients.”
A co-author of the recent Scientific Reports paper, Anahit Ghochikyan, an IMM Department of Molecular Immunology associate professor, said: “This study suggests that we can immunize patients at the early stages of AD, or even healthy people at risk for AD, using our anti-amyloid-beta vaccine, and, if the disease progresses, then vaccinate with another anti-tau vaccine to increase effectiveness.”
She says the cooperative studies with IMM scientists and collaborators from UCI and the University of Southern California are working with experts from four companies to conduct nonclinical safety-toxicology studies to satisfy the standards for an Investigational New Drug application in the United States.
After completion of these preclinical studies, they plan to test the immunogenicity and efficacy of the new vaccines in human trials.