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Dementia Immunotherapy Vaccine May Proceed in Phase 1/2a Study

October 31, 2022 • 10:10 am CDT
by Gundula Vogel
(Precision Vaccinations News)

Alzamend Neuro, Inc. announced today the receipt of a "Study May Proceed" letter from the U.S. FDA for a phase I/IIA clinical trial under its Investigational New Drug ("IND") application for ALZN002 to treat mild to moderate dementia of the Alzheimer's type.

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 patient that is 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.

"There remains a need to develop new therapies that alter the progression of Alzheimer's and prevent, reverse or slow neurodegeneration and cognitive decline," said Stephan Jackman, Chief Executive Officer of Alzamend, in a press release on October 31, 2022.

"We strongly believe that the ALZN002 patient-specific immunotherapeutic vaccine has the potential to achieve these objectives and bring aid to the millions of Americans afflicted with this devastating disease."

"We are advancing the process and expect that the first patient will be dosed in the first quarter of 2023."

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.

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 that reported encouraging Alzheimer's disease-related measurements and neurobehavioral effects.

Other Alzheimer's disease vaccine candidate news is posted at PrecisionVaccinations.com/Alzheimers.

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