Alzamend pushed for an Alzheimer’s vaccine trial
Alzamend Neuro, Inc. has announced the start of a phase I/IIA clinical trial for its immunotherapy vaccine (ALZN002) to treat mild to moderate dementia of the Alzheimer’s type.
The aim of this trial was to assess the increased safety, tolerability, and efficacy of dual-dose ALZN002 compared with placebo in 20 to 30 subjects with mild to moderate morbidity. The main goal of this clinical trial is to determine the appropriate dose of ALZN002 for the treatment of patients with Alzheimer’s in a larger phase IIB efficacy and safety clinical trial, which Alzamend is expected to begin within three months of receiving data from the initial trial.
“Alzamend’s motto is ‘Make Alzheimer’s just a memory.’ There is still a need to develop new therapies that modify the development of Alzheimer’s and prevent, reverse or slow down neurodegeneration and cognitive decline. Today, we are on the important threshold of advancing the art and science of anti-beta amyloid therapy by treating the individual immune system of each Alzheimer’s patient,” said Stephan Jackman, chief executive of Alzamend.
“Intermittent use of our immunotherapy vaccine (ALZN002) can be expected to limit the number of infusions needed, can reduce the potential for adverse reactions, and provide more substantive cognitive and functional outcomes to the millions of Americans suffering from this devastating disease.”
ALZN002 from Alzamend
ALZN002 is a proprietary ‘active’ immunotherapy product, which means it is produced by each patient’s immune system. It consists of autologous dendritic cells (DCs), which are activated white blood cells harvested from patients that are then engineered outside the body to attack the Alzheimer’s-associated amyloid-beta protein.
These DCs are filled with a new amyloid-beta peptide (E22W) designed to enhance a patient’s immune system’s ability to combat Alzheimer’s. The goal of this treatment approach is to develop tolerance to the medication for safety purposes while stimulating the immune system to reduce the brain’s beta-amyloid protein load, thereby reducing the signs and symptoms of Alzheimer’s.
The treatment of ALZN002 DC is individual patient-specific therapy because these autologous DCs are administered to the same patients from whom they were excluded. Each sufferer will experience leukapheresis, which is the removal and return of white blood cells into the body. This procedure will isolate each patient’s peripheral blood monocytes from the white blood cells obtained. These are then differentiated outside the body into DCs that are engineered to induce immunogenicity (the ability to seek and destroy) against amyloid, a protein associated with Alzheimer’s in patients’ bodies, but are otherwise tolerated as natural in the body to avoid adverse side effects.
Safe and effective
Compared to passive immunization treatment approaches using foreign blood products (such as monoclonal antibodies), active immunization with ALZN002 is anticipated to have a more potent and lasting effect on amyloid clearance. This is expected to provide a safe and effective treatment for Alzheimer’s sufferers who require treatment visits that are far less frequent than passive immune approaches.
Several pre-clinical studies have been conducted using transgenic (or genetically modified) mouse models of Alzheimer’s disease at the University of South Florida and Charles River Laboratories. This is reported to drive Alzheimer’s disease-related measures and neurobehavioral effects, supporting this application of IND. Strong evidence of significant ALZN002-mediated reduction of amyloid plaques was observed in a mouse model of the disease.
There were no undue adverse findings in the good practice laboratory toxicology study, which consisted of five injections given over a 90-day period and evaluated 90 days after the last dose. Histopathological results showed that there was no indication of T cell infiltration or meningoencephalitis (inflammation of the membranes surrounding the brain), indicating that ALZN002 is safe and well tolerated.
Additionally, there were no treatment-related deaths or reports of adverse events at clinical observations during the main study or recovery phase.
Funding for Alzheimer’s
EQT Life Sciences recently closed its inaugural LSP Dementia Fund, raising approximately €260 million ($283 million) in cost-generating assets under management.
The LSP Dementia Fund is dedicated to investing in companies that are developing breakthrough drug therapies and medical technologies across the spectrum of neurodegenerative diseases.