SOURCE: Capo Therapeutics, Inc.

July 05, 2016 16:12 ET

Unique Alzheimer's Disease Vaccines Show Great Potential in Pre-Clinical Studies

High Titers Are Achieved Through Proprietary Composition

OCEANSIDE, CA --(Marketwired - July 05, 2016) - Capo Therapeutics, Inc., announced today that researchers at The Institute of Molecular Medicine in Huntington Beach, CA, along with collaborators at the University of California at Irvine, Irvine, CA and at Flinders University in Adelaide, Australia have created a unique vaccine formulation and approach that may overcome historical problems with vaccines against the proteins which drive Alzheimer's Disease (AD).

Alzheimer's Disease is the most common cause of dementia. Immunotherapeutic strategies targeting two central pathological proteins, B-amyloid (AB) and tau, have displayed strong disease-modulating effects in animal models of AD, leading to attempts by industry to use anti-AB or anti-tau therapeutics in clinical trials. Unfortunately, the majority of active vaccines targeting AB pathology have failed in clinical trials likely because (i) they were not initiated as early as possible in people who are at AD risk, are prodromal, or have mild AD and (ii) they were not successful at inducing therapeutically potent concentrations of anti-AB antibodies.

The research team in this study used several steps to optimize their approach and overcome traditional roadblocks. First they decided to target B cell antigenic epitopes from AB and tau proteins that are found in the disease state. Then, these were fused to a universal vaccine platform that is based on a string of Th foreign epitopes, called Multi-TEP. Next, an inulin-based adjuvant was added and finally, they suggested that in future clinical trials the timing of vaccination be controlled by using a sequential strategy. In other words, the authors concluded that an optimal AD vaccine formulation, adjuvant selection and targeting of the right pathological molecules at the right stage of disease will be crucial to a successful immunotherapeutic approach.

The result of this approach yielded very high therapeutic titers of anti-AB and anti-tau antibodies as well as inducing powerful cellular immune responses in animal models. The antibodies generated bound strongly to brain tissue from AD cases indicating the therapeutic potential of these antibodies. Immune sera from animals vaccinated with both anti-tau and anti-AB vaccines, or with a dual vaccine targeting both pathological molecules, recognized AB and tau simultaneously in human brains from AD cases. This approach may be especially beneficial in the elderly because the vaccine utilizes memory T cells that are in abundance in elderly patients instead of relying on activation of naive T cells, which decline with age.

"This study suggests that we can immunize patients with early stages of AD with our anti-AB vaccine and, if it progresses, then vaccinate with our anti-tau vaccine," says Dr. Michael Agadjanyan, Professor and Head of Immunology at the Institute for Molecular Medicine and faculty at the Institute for Memory Impairments and Neurological Disorders, UCI, and one of the senior authors of the study. "No other studies have achieved the level of effective antibody titers we have achieved so I am excited to take this into the clinic. It is a completely novel approach."

Furthermore, Dr. Agadjanyan said, "Any vaccine will not be effective if it is not inducing therapeutically potent concentrations of antibodies. To generate an immunogenic formulation of AD vaccines we tested various GMP-grade adjuvants and selected a novel pharmaceutical-grade adjuvant, called AdvaxCpG. This adjuvant derived from delta inulin provides optimal immune enhancement for all types of AD vaccines based on the MultiTEP platform. Importantly, our MultiTEP platform-based vaccines are not inducing potentially harmful autoreactive cellular immune responses."

The composition of matter, formulation and methods of use have been submitted to the US patent office and has been exclusively licensed to Capo Therapeutics, Inc., a company started to commercialize this approach.

Study results appear in the Nature Publishing Group journal of Scientific Reports
http://www.nature.com/articles/srep28912

About Capo Therapeutics, Inc.

Capo Therapeutics, Inc. is a company focused on bringing to the clinic vaccination strategies for various neurological disorders, in particular Alzheimer's Disease, Lewy Body Dementia, Traumatic Brain Injury, as well as Parkinson's Disease, and Huntington Disease. www.capotherapeutics.com

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