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

Nuravax Acquires Rights for MultiTEP Vaccine Platform Tech

The nonprofit Institute for Molecular Medicine (IMM) has licensed its universal vaccine platform technology — called MultiTEP — to Nuravax, a biotech developing therapies for Alzheimer’s disease and other disorders of the central nervous system.
MultiTEP is a vaccine platform that can generate very high levels of antibodies against toxic proteins that clump together in the brains of older people, driving neurodegenerative diseases.
In the case of Alzheimer’s, the vaccines are targeted against toxic clumps of amyloid-beta and tau proteins, the two hallmarks of the disease.
According to the IMM, the platform combines a dozen antigen fragments (epitopes) used in previously established vaccines. An antigen is a molecule or a molecular structure that can bind to cells of the immune system and trigger an immune response. An epitope is the part of an antigen that is recognized by the immune system.
Together the epitopes induce a potent immune response and boost the production of high antibody titers by activating key cells of the immune system, namely T helper cells.

“The AD [Alzheimer’s disease] and PD [Parkinson’s disease] vaccines in development based on our MultiTEP platform contain 12 protein segments (epitopes) from vaccines that have been administered to the general population during their lifespans,” Michael Agadjanyan, PhD, vice-president of IMM, said in a press release.
“When linked together these epitopes strongly activate both naïve and memory T helper cells,” Agadjanyan said.
As people age, their immune systems produce fewer of these naïve T helper cells, which are key to recognizing antigens that will trigger an immune response. Besides naïve T helper cells, memory T helper cells are required for the generation and maintenance of a long-lived “immune memory” — the capacity of the immune system to “remember” and quickly trigger an immune response once in presence of a pathogen (a microbe or a virus, for example) or a previously seen antigen delivered via vaccine.
“T helper cells are part of the immune system and are crucial to stimulating the production of antibodies by B cells,” Agadjanyan said. “By leveraging existing memory T cells, we have seen that MultiTEP can elicit a high and quick production of antibodies that could block the accumulation of pathological amyloid beta and tau in the brains of vaccinated people at risk of [Alzheimer’s] and at least delay the disease onset.”
Prior preclinical studies showed that immunization with two experimental vaccines targeting the toxic forms of amyloid-beta and tau protein triggered an immune response that reduced the levels of both proteins in the brain of a mouse model of the Alzheimer’s.
According to Nuravax, the levels of antibodies detected in the blood of animals treated with its vaccines were significantly higher than 50,000, which is several times greater than the levels obtained with other vaccines being tested in clinical trials.
“As an entrepreneur, I have always made a point to purposely take leadership roles in my investments that have demonstrated a potential meaningful medical impact in a market with significant need and opportunity,” said Roman Kniazev, CEO of Nuravax.
Nuravax has appointed as its new medical director Lon Schneider, MD, director of USC State of California Alzheimer’s Disease Center, and Jim Calla, PhD, a vaccine clinical trial expert.
With the licensing agreement and its new leadership, Nuravax is “poised to change the landscape of neurodegenerative disease prevention,” Kniazev said.