Alzamend Neuro, Inc. has announced the initiation of a phase I/IIA clinical trial for its immunotherapy vaccine (ALZN002) to treat mild to moderate dementia of the Alzheimer’s type.
The purpose of the trial is to assess the safety, tolerability, and efficacy of multiple ascending doses of Alzamend Neuro’s ALZN002 compared with that of placebo in 20 to 30 subjects with mild to moderate morbidity. The primary goal of this clinical trial is to determine an appropriate dose of ALZN002 for treatment of patients with Alzheimer’s in a larger phase IIB efficacy and safety clinical trial, which Alzamend Neuro expects to initiate within three months of receiving data from the initial trial.
“Alzamend’s motto is ‘Making Alzheimer’s just a memory.’ There remains a need to develop new therapies that alter the progression of Alzheimer’s and prevent, reverse or slow neurodegeneration and cognitive decline. Today, we are on the threshold of importantly advancing the art and science of anti-beta amyloid therapy by treating each Alzheimer’s patient’s individual immune system,” said Stephan Jackman, chief executive officer of Alzamend Neuro.
“Intermittent use of our immunotherapeutic vaccine (ALZN002) may be expected to limit the number of infusions needed, may reduce the potential for adverse reactions, and provide more substantive cognitive and functional outcomes to the millions of Americans afflicted with this devastating disease.”
Alzamend Neuro’s ALZN002
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 taken from the patient that are then engineered outside of the body to attack Alzheimer’s-related amyloid-beta proteins.
These DCs are pulsed with a novel amyloid-beta peptide (E22W) designed to bolster the ability of the patient’s immune system to combat Alzheimer’s. The goal of this treatment approach is to foster tolerance to treatment for safety purposes while stimulating the immune system to reduce the brain’s beta-amyloid protein burden, resulting in reduced Alzheimer’s signs and symptoms.
The ALZN002 DC treatment is an individual-patient-specific therapy since these autologous DCs are administered to the same patient from whom they were removed. Each patient will undergo leukapheresis, which is the removal and return to the body of white blood cells. This procedure will isolate each patient’s peripheral blood monocytes from the obtained white blood cells. These are subsequently differentiated outside the body into DCs that are engineered to induce immunogenicity (search and destroy capability) towards amyloid, the protein associated with Alzheimer’s in the patient’s body, but to be otherwise tolerated as natural to the body to avoid adverse side effects.
Safe and effective
Compared to passive immunization treatment approaches that use foreign blood products (such as monoclonal antibodies), active immunization with Alzamend Neuro’s ALZN002 is anticipated to offer a more robust and long-lasting effect on the clearance of amyloid. This is expected to provide a safe and effective treatment for Alzheimer’s sufferers that requires considerably less frequent treatment visits compared to passive immunity approaches.
Multiple pre-clinical studies have been conducted using a transgenic (or genetically modified) mouse model of Alzheimer’s disease at the University of South Florida and Charles River Laboratories. These reported encouraging Alzheimer’s disease-related measurements and neurobehavioral effects, supporting this IND application. Strong evidence of significant ALZN002‑mediated amyloid plaque reductions was observed in mouse disease models.
There were no undue adverse findings in a good laboratory practices toxicology study, which consisted of five injections administered over a 90-day period and evaluated for 90 days after the last dose. Histopathology results demonstrated that there were no indications of T-cell infiltration or meningoencephalitis (inflammation of the membranes that surround the brain), suggesting that Alzamend Neuro’s ALZN002 is safe and tolerable.
In addition, there were no treatment-related mortalities or reports of adverse effects on clinical observations during the main study or the recovery phase.
Funding for Alzheimer’s
EQT Life Sciences recently closed its inaugural LSP Dementia Fund, raising approximately €260 million ($283 million) in fee-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.