FDA’s Decision to Approve New Treatment for Alzheimer’s Disease

The Institute for Molecular Medicine has Received a Total $7.7M From NIH to Develop a First-of-its-Kind Vaccine Targeting Both Hallmarks of Alzheimer's Disease

Newswise — HUNTINGTON BEACH, Calif., Nov. 22, 2021 /PRNewswire/ -- The Institute for Molecular Medicine (IMM), a non-profit research organization established in 1996 with the goal of understanding, preventing, and curing chronic diseases, including neurodegenerative disorders, today announced that it has been awarded an additional $3 million to the previously awarded $4.7 million grant from the National Institutes of Aging (NIA) of the NIH. The funding will support the manufacturing of a first-of-its-kind clinical cGMP grade dual vaccine, Duvax, that targets both pathological hallmarks of Alzheimer's disease (AD), amyloid beta plaques (Aβ) and neurofibrillary tangles (tau). 
First clinical trials of a dual vaccine for Alzheimer's disease to begin in 2023
Current clinical data on AD biomarkers found in the brain and cerebrospinal fluid demonstrate that Aβ accumulation can precede tau pathology and cognitive decline by sometimes more than a decade. The IND-enabling safety/toxicology studies with a cGMP grade recombinant protein vaccine targeting tau, AV-1980R, has been recently completed using the NIA funding and is currently on track for a Phase 1 clinical trial to evaluate its safety, tolerability, and immunogenicity. The additional funding is being used to manufacture a clinical grade recombinant protein vaccine targeting pathological Aβ, AV-1959R, and test its safety in animal models of AD. This vaccine will be tested in 2022 in a clinical setting. Importantly, the additional funding will also be used to manufacture Duvax for use in phase 1 trials that are expected to be completed in 2023.
"Supported by strong pre-clinical data, we believe that Duvax will induce high titers of anti-Aβ and anti-tau antibodies that could inhibit or reduce the accumulation of both pathological molecules and halt or at least delay downstream pathological processes, such as inflammation and neurodegeneration, which would otherwise lead to an irreversible onset of AD in asymptomatic people at risk," said Vice President of IMM and Head of Immunology Michael Agadjanyan.
All vaccines are based on IMM's proprietary MultiTEP platform technology, recently licensed to its commercial entity, Nuravax, that has demonstrated therapeutic efficacy and immunogenicity in special transgenic mouse models of AD, rabbits, and non-human primates with human-like immune systems.
"With three INDs, two single-target vaccines and Duvax, we will be able to continue developing a pipeline that could prevent Alzheimer's disease from multiple angles," said Nuravax CEO Roman Kniazev.
About MultiTEP
The universal proprietary MultiTEP carrier platform is the key feature of IMM's vaccine candidates for Alzheimer's disease (AD) and Parkinson's disease (PD). Elderly immune systems are characterized by a deficiency of naïve T helper cells but fortunately, exhibit an increase of memory T helper cells. MultiTEP technology-based vaccines should overcome the shortcomings of aged immune systems by activating not only naïve but also memory T helper cells and mount a strong antibody response, especially in the elderly.
About the IMM
The Institute for Molecular Medicine (IMM) is a non-profit organization created with the goal of understanding, preventing, and curing chronic human diseases, including Alzheimer's disease and Parkinson's disease. IMM is advancing MuliTEP, a universal vaccine platform technology that supports the development of multiple vaccine designs based on DNA, RNA, or recombinant proteins.
About Nuravax
Nuravax is licensed for the patented MultiTEP platform technology for the commercialization of prophylactic vaccines against all neurodegenerative disorders. Nuravax is responsible for implementing co-development and sub-licensing agreements with larger biotech and pharmaceutical companies, and for further clinical validation of products. For more information, please visit www.nuravax.com and follow us on LinkedIn.