Alzheimer’s disease is the most common type of dementia, and impairs the ability of patients to live independently. This neurodegenerative condition lacks effective treatments, with the antibody drugs Aduhelm and Leqembi being the only medicines cleared by the U.S. Food and Drug Administration (FDA) to change the course of the disease at an early stage.
To provide more treatment options in Alzheimer’s, Alzamend Neuro is developing a vaccine that boosts the immune system’s ability to fight the condition. This is based on a hypothesis that the immune system is naturally able to clear harmful plaques made of the protein amyloid-beta. As we age, however, this clearance slows, leading to plaque buildup and the development of Alzheimer’s. The aim is to therefore reinforce the immune system’s natural anti-amyloid response.
The vaccine consists of taking immune cells from the patient and culturing them to become dendritic cells, which are instrumental to alerting the immune system to the presence of pathogens. The company incubates the dendritic cells in the lab with amyloid-beta and then reinfuses them into the patient.
Once in the patient, the engineered dendritic cells orchestrate an immune response against amyloid-beta to reduce the symptoms of Alzheimer’s. At the same time, the infused cells are seen by the patient’s immune system as part of itself, reducing side effects. Additionally, the vaccine is designed to be used without an adjuvant, which can also risk side effects.
In October 2022, the FDA gave Alzamend the all-clear to begin its phase 1/2a trial in 20-30 patients with mild to moderate dementia of the Alzheimer’s type, and the company launched the placebo-controlled trial this month. The aim is to identify an appropriate dose of the vaccine for a larger phase 2b trial that will investigate the efficacy and safety of the vaccine. The larger trial is expected to begin within three months of receiving data from the initial trial.
Alzamend’s Nasdaq stock price was buoyed by the trial announcement, and jumped by more than 5% since yesterday to around $0.49.
“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,” said Stephan Jackman, Chief Executive Officer of Alzamend, in a public statement. “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.”
Alzamend says that its vaccine could have a longer-lasting effect than anti-amyloid-beta antibodies, meaning fewer visits to the clinic for patients.
Dendritic cell vaccines have been explored in the past, as their central role to the immune response makes them candidates for cancer immunotherapies. However, their application in treating disorders of the central nervous system is still at a very early stage.
In addition to its vaccine candidate, Alzamend is developing a patented form of lithium for the treatment of Alzheimer’s as well as for bipolar disorder, major depressive disorder and post-traumatic stress disorder. Lithium has been sold for decades as a medicine for psychiatric disorders, and the company plans to test its ability to protect brain tissue from Alzheimer’s. Topline data from a phase 2 trial for the candidate in Alzheimer’s disease are expected in June 2023.
In its latest quarterly financial report, Alzamend reported $7.4m in cash reserves as of January 31st, 2023. David Katzoff, Chief Financial Officer of Alzamend, explained that the firm expects another $14.8m in 2023 as a note receivable issued to them from a prior sale of their common stock. He added that the firm has maintained a low cash burn and capped its workforce to four full-time and three part-time employees.