Innovative Alzheimer's Disease Vaccine Candidate Can Add Value
While the U.S. government has recently licensed monoclonal antibody therapies (LEQEMBI®), anti-amyloid vaccines may offer a convenient, affordable, and accessible means of preventing and treating Alzheimer's Disease (AD).
The Lancet's eBioMedicine recently published a paper that concludes that UB-311, an immunotherapeutic vaccine candidate targeting toxic forms of aggregated beta-amyloid in the brain to treat and prevent AD, is the most advanced active immunotherapy targeting beta-amyloid in the clinic.
Published on July 29, 2023, this research paper concludes Vaxxinity, Inc. UB-311 is an active immunotherapy, "was safe and well-tolerated," with early clinical data demonstrating a trend for slowing cognitive decline in mild Alzheimer's disease (AD).
And UB-311 could offer multiple competitive advantages over licensed passive immunotherapies, including less frequent dosing, a more convenient mode of administration, improved accessibility, and cost-effectiveness.
Furthermore, UB-311 is designed to produce antibodies against toxic beta-amyloid (Aβ) oligomers and fibrils in the brain.
This phase 2a clinical study met its primary prespecified outcomes.
It indicated the safety of active immunotherapy with UB-311 in amyloid PET-positive individuals with mild Alzheimer's dementia taking multiple doses over an extended period.
Mei Mei Hu, Vaxxinity CEO, informed Precision Vaccinations on August 13, 2023, "Even with a fully FDA-approved mAb for Alzheimer's on the market, high unmet need remains that we believe only an active immunotherapy can address: specifically one that is more convenient, safe and accessible for patients, caregivers and health systems."
"Active immunotherapies like UB-311 have the potential to reach dramatically more people compared to costly monoclonals because they can be more affordable, dosed less frequently and not need to be administered at specialized infusion centers, and thus, be scaled to address the broadest patient population including ultimately for prevention."
"The recent peer-reviewed publication of our Phase 2a trial is a testament to our continued efforts to eradicate AD."
The limitations of this company-funded study include the small sample size, indicating that additional trials in a larger participant population will be needed to confirm the results.
Alzheimer's is a progressive neurodegenerative disease poised to be one of the most significant socioeconomic health burdens globally over the coming decades.
In the United States, about 11% of seniors (≥65 years) currently have Alzheimer's dementia, and this proportion is expected to grow with the aging population. The economic burden of AD is expected to surpass $2.8 trillion by 2030.
Recently, the AP reported on August 11, 2023, some private insurers are balking at paying for U.S.-approved Alzheimer's mAb therapies. These mAbs require IV infusions every two weeks, costing around $26,500 annually.
These insurers contrast Medicare, which previously announced it would cover most of the costs for patients who take these mAbs.
Note: The article was updated for content and clinical clarity on August 16, 2023.