Alzamend submits IND application for Alzheimer’s vaccine trial

Alzamend Neuro has submitted an investigational new drug application to the FDA for its Alzheimer’s immunotherapeutic product, ALZN002, according to a company press release.

The application supports randomized, double-blind, placebo-controlled phase 1/2A clinical trials of the product candidate, which consists of autologous dendritic cells that attack amyloid-beta proteins as well as induce the patient’s own antibodies against Alzheimer’s disease.

The company explained in a press release that white blood cells are taken from each patient to be engineered outside of the body to attack the Alzheimer’s proteins. These autologous dendritic cells are pulsed with E22W, a novel amyloid-beta peptide, to bolster the ability of the patient’s immune system to fight Alzheimer’s disease.

Alzamend said in the release that the goal is to foster tolerance to the treatment while stimulating the immune system to reduce the brain’s beta-amyloid protein burden, which should result in reduced Alzheimer’s signs and symptoms.

“This IND submission represents a key milestone for Alzamend as we continue to advance our proprietary pipeline. There remains a need to develop new therapies that alter the progression of Alzheimer’s and prevent, reverse or slow neurodegeneration and cognitive decline,” Alzamend CEO Stephan Jackman said in the release. “We strongly believe that the ALZN002 patient-specific immunotherapeutic vaccine has the potential to achieve these objectives and bring aid to the 6-plus million Americans afflicted with this devastating disease.”