Nov 01, 2022 6:30 AM
ALZN002 is believed to be the first autologous dendritic cell-based active immunotherapy vaccine candidate to be tested in humans to treat Alzheimer’s
ALZN002 is believed to be the first candidate autologous (uses the patient’s own cells) dendritic cell-based Alzheimer’s immunotherapy vaccine to be tested in humans that potentially fosters tolerance to treatment (for safety) while providing durable active immunity potential and fewer physician visits compared to passive (foreign to the patient) immunity treatments.
Alzamend reported that it expects to initiate the clinical trial in the first quarter of 2023.
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 each individual 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 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, by definition, 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, i.e., 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.
Compared to passive immunization treatment approaches that use foreign blood products (such as monoclonal antibodies), active immunization with 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.
The IND supports initial deployment of a Phase I/IIA clinical trial, ALZN002-01, a first-in-human, randomized, double-blind, placebo-controlled, parallel-group study. The purpose of this trial will be to assess the safety, tolerability, and efficacy of multiple ascending doses of ALZN002 compared with that of placebo in 20 to 30 subjects with mild to moderate dementia of the Alzheimer’s type. Also, the trial will be designed to determine the optimal dosage of ALZN002 for treatment of patients with Alzheimer’s in a larger Phase IIB efficacy and safety clinical trial (ALZN002-02), which Alzamend expects to initiate within three months of receiving data from the initial trial.
Milton “Todd” Ault, III, the Company’s Executive Chairman and the Founder and Chairman Emeritus of Alzamend, stated, “I could not be more pleased with the FDA’s ‘Study May Proceed’ allowing Alzamend to begin to test its immunotherapy vaccine in patients with Alzheimer’s. It has been a life-long goal of mine to help people suffering from Alzheimer’s. I believe that a vaccine will play the biggest role in the fight against Alzheimer’s.”
The Company has certain beneficial ownership and rights to further invest in Alzamend. The Company beneficially owns approximately 10.4 million shares and has the right to acquire 3.4 million shares of Alzamend common stock upon the exercise of warrants. In addition, the Company’s wholly owned subsidiary,
Should the Company exercise all warrants and options to invest, it would own approximately 23.8 million shares with an average cost of
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