November 29, 2021

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Alzheimer’s disease vaccine is coming and Phase 2 clinical trials are safe

Alzheimer’s disease vaccine is coming and Phase 2 clinical trials are safe

 

 

Alzheimer’s disease vaccine is coming and Phase 2 clinical trials are safe .  The Alzheimer’s disease vaccine is here! Phase 2 clinical trials are safe and can induce immune responses in patients

On June 7, 2021, the FDA announced the accelerated approval of Biogen’s monoclonal antibody aducanumab for the treatment of Alzheimer’s induced mild cognitive impairment (MCI) and mild Alzheimer’s disease. This is the first new drug approved by the FDA for the treatment of Alzheimer’s disease since 2003, and it is also the first drug that can prevent the progression of the disease.

The FDA’s approval caused fierce controversy, including excitement, surprise, and many disappointments.

Alzheimer’s disease (Alzheimer’s disease, AD), commonly known as “Alzheimer’s disease”, is a severe neurodegenerative disease. Patients usually suffer from symptoms such as memory decline, weakened learning ability, and emotional regulation. Obstacles and loss of athletic ability greatly affect the development of individuals, families and even society.

Currently, about 50 million people worldwide suffer from Alzheimer’s disease. As the average life expectancy of human beings increases and the aging society intensifies, the prevalence of Alzheimer’s disease is also rising. It is estimated that by 2050, Alzheimer’s patients will increase to more than 150 million.

The cause of Alzheimer’s disease is complex, and the scientific community has not yet deciphered the specific mechanism of Alzheimer’s disease. Initially, scientists believed that the cause of Alzheimer’s disease was the nerves caused by β-amyloid protein (Aβ) deposition. Yuan died in large numbers. However, many pharmaceutical giants, including Pfizer, Roche, and Merck, spent billions of dollars on Aβ, but they all lost their lives. The FDA-approved Biogen monoclonal antibody drug aducanumab also targets Aβ, so it is widely controversial.

In addition, more and more studies have shown that Tau protein deposition is the main cause of cognitive decline in patients with Alzheimer’s disease. Therefore, if a preventive vaccine is developed for Tau protein, can it train the immune system to attack and remove Tau protein, thereby preventing it from depositing and harming neurons, thereby preventing Alzheimer’s disease?

On June 14, 2021, Axon Neuroscience published a clinical trial report titled ADAMANT: a placebo-controlled randomized phase 2 study of AADvac1, an active immunotherapy against pathological tau in Alzheimer’s disease in the journal Nature Aging, a subsidiary of Nature.

The results of this phase 2 clinical trial show that the AADvac1 vaccine targeting Tau protein is safe and can induce immune responses in patients with mild Alzheimer’s disease. However, the specific impact of the AADvac1 vaccine on the cognitive decline of patients with Alzheimer’s disease has not yet been determined.

 

Alzheimer's disease vaccine is coming and Phase 2 clinical trials are safe

The toxic form of Tau protein will accumulate and spread in the brains of Alzheimer’s patients, which is also a significant pathological feature of Alzheimer’s. In patients with Alzheimer’s disease, Tau protein loses its natural flexible structure, presents a stronger structure, and forms Tau protein aggregates, resulting in neurofibrillary tangles observed in the patient’s brain, causing nerves Yuan died in large numbers, which eventually led to the decline of patients’ cognitive ability.

Professor Michal Novak is one of the first scientists to discover the influence of Tau protein on the development of Alzheimer’s disease. He founded Axon Neuroscience in 1999 and is committed to reducing the level of Tau protein through immunotherapy to help slow the development of Alzheimer’s disease. Cognitive decline.

Alzheimer's disease vaccine is coming and Phase 2 clinical trials are safe Alzheimer's disease vaccine is coming and Phase 2 clinical trials are safe
Professor Michal Novak, founder of Axon Neuroscience

 

15-20 years ago, it was difficult for research on Tau protein to be included in top academic journals, because Aβ was the mainstream at that time, and many pharmaceutical giants invested huge amounts of money in Aβ, and they had to continue to advance. But now, at least 50% of Alzheimer’s research is related to Tau protein. In recent years, many pharmaceutical giants have turned to the development of Tau protein, and at least 10 Tau protein antibodies are currently undergoing clinical trials.

In 2013, Axon Neuroscience launched the first clinical trial of the vaccine for 30 patients with mild to moderate Alzheimer’s disease. The test results showed that the vaccine is safe and well tolerated by patients. A very high immune response to Tau protein was also observed in patients.

In 2020, Axon Neuroscience completed a phase 2 randomized placebo-controlled trial of the vaccine, enrolling 196 patients with mild Alzheimer’s disease (mean age 71.4 years; 45.1% male; 100% white). Researchers injected these patients with multiple doses of a peptide vaccine called AADvac1 or a placebo, and monitored the safety, immunogenicity (that is, the ability of the vaccine to induce an immune response) and clinical efficacy of the vaccine over a period of two years.

The research team found that the vaccine is safe as a whole, and the vaccination group can produce a large number of antibodies to the peptides of the vaccine. However, this vaccine did not have a statistically significant positive or negative effect on the cognitive function of the entire study sample.

Exploratory analysis showed that AADvac1 can slow down the accumulation of neurofilament light chain (NfL)-NfL is a marker of neurodegeneration. The research team believes that this shows that the use of the vaccine can slow down neurodegeneration.

Alzheimer's disease vaccine is coming and Phase 2 clinical trials are safe

 

The research team concluded that although patients tolerate AADvac1 well and can produce an immune response to tau protein, the vaccine cannot produce statistically significant cognitive benefits, which may be due to the lack of Tau protein pathological manifestations in some patients , Or because the sample size of the study is small.

Therefore, it is still necessary to conduct larger-scale stratified trials based on the existence of disease biomarkers, repeat the above research results and fully evaluate the possible clinical efficacy of AADvac1.

 

It is reported that Axon Neuroscience is now preparing to start phase 3 clinical trials, and if successful, it will promote the launch of the vaccine. The company has been funded by private investors from the beginning, but the leadership team said it is now looking to work with larger players to help the vaccine enter the U.S. and European markets in 2025.

 

(source:internet, reference only)


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