Available Information Identifies the Reasons for the Past Clinical Setbacks and the Need for Effective Immunogens and a Sole Th2 Immunoresponse.

Qantu Therapeutics, Inc. announces the publication of the article "A retrospective analysis of the Alzheimer's disease vaccine progress - The critical need for new development strategies" in the peer-reviewed leading Journal of Neurochemistry. This review, authored by Dr. Dante Marciani, President and CSO of Qantu, examines the problems that have hindered this vaccine's development and discusses strategies to develop effective vaccines against this disease. In effect, the recovery of cognitive functions in patients with early stage of Alzheimer's and treated with aducanumab, supports the concept of preventive vaccines against this disease; i.e. this monoclonal antibody mimics natural protective antibodies against Alzheimer's disease. Moreover, the prevention/delay of Alzheimer's onset by prolonged pre-treatment of healthy individuals with immunoglobulins strengthens the protective role of natural immunity. Hence, effective vaccines should reproduce that natural protective immunity; an endeavor to which Qantu is committed by developing novel and proprietary anti-inflammatory vaccine adjuvants that act on the dendritic cells.

Reports that the immunogens used in Alzheimer's vaccines elicit an antibody response against monomeric, but not neurotoxic oligomeric amyloid-β, disagree with the fact that natural protective antibodies against this disease target the amyloid-β oligomers and not its monomers; a situation that raises questions about those immunogens' suitability. Besides, that inflammatory immunity is damaging in Alzheimer's, limits the useful response induced by these vaccines to a sole anti-inflammatory antibody-only one. Hence, a major obstacle in the development of useful Alzheimer's vaccines has been the scarcity of immunomodulators or adjuvants that elicit that required sole Th2 anti-inflammatory immunity. In fact, adjuvants are critical for vaccines, as they alone decide the nature of the immune response, directing the body to produce either Th2 humoral anti-inflammatory or Th1 pro-inflammatory cell-mediated immunity. But, the available adjuvants predominantly elicit an immunity that is a mixture of both Th1 and Th2, which is unacceptable for vaccines to prevent and/or treat proteinopathies like Alzheimer's disease.

The relevance of a procedure that prevents this disease, such as a vaccine, is shown by a report from the Alzheimer's Association, which estimates that a treatment that in 2025 delays the onset of this disease by five years would decrease the number of cases in the US from 8.2 million to 5.8 million. A change that would result in 2030 in savings in cost care of over $83 billion, benefits that would continue to increase with time. Thus, due to their cost effectiveness and convenient use, development of vaccines to prevent and/or delay the onset of Alzheimer's would be of major benefit worldwide.

Dr. Dante Marciani commented: "The article is the first to analyze and explain the errors that have besieged the AD vaccine development and led the researchers from the public and private sectors, as well as financial institutions, to reach the conclusion that such a vaccine is unfeasible. While I was responsible for initiating and directing the development of QS-21, I never was consulted by the different groups using it or equivalent products in AD vaccines. Indeed, I could have told them what a highly respected neurologist told me in the mid 1980s: use of QS-21 will result in serious damage to the brain; something that 15 years later after spending several hundred million dollars was confirmed. However, major problems were also derived from the selection of the antigen, which instead of inducing a protective immunity elicits a damaging one, as it has been shown recently by different groups."1

"A retrospective analysis of the Alzheimer's disease vaccine progress - The critical need for new development strategies" Dante J. Marciani. Journal of Neurochemistry, DOI: 10.1111/jnc.13608. Article first published online: 6 APR 2016.