Vaxxinity publishes positive results in Alzheimer’s trial

Immunotherapy drug found to be safe, well-tolerated and demonstrates trend for slowing cognitive decline in mild Alzheimer’s.

Immunotherapeutic vaccine developer Vaxxinity (Nasdaq: VAXX) has published Phase 2a clinical trial data for its active immunotherapy candidate, UB-311, in Alzheimer’s disease. The data, published in The Lancet’s eBioMedicine journal, shows that UB-311 “was safe and well-tolerated” and demonstrated a trend for slowing cognitive decline in mild AD.

The Phase 2a trial was a 78-week, randomized, double-blind, placebo-controlled study conducted in Taiwan. UB-311 demonstrated safety and tolerability, with no reported cases of ARIA-related edema and limited instances of asymptomatic ARIA-related hemosiderin deposits.

The trial was not designed to definitively establish efficacy, but trends were observed in slowing cognitive decline for UB-311-treated participants compared to those on placebo. Notably, participants in the UB-311 quarterly boosting group exhibited a 48% slowdown in decline on a key cognitive measure.

“The UB-311 Phase 2a program accomplished its goals of establishing safety and tolerability, while generating high levels of anti-amyloid antibodies,” said Dr Jeffrey Cummings of the University of Nevada, Las Vegas, and co-author of the paper. “The gradual, natural titration of antibody titers through this approach may have contributed to a lack of ARIA-E in this study. Vaccine approaches such as UB-311 represent important ways forward in advancing treatment and prevention of Alzheimer’s disease and offer the potential to transform the treatment landscape by providing participants with an accessible therapeutic option.”

UB-311 is a synthetic, peptide-based active immunotherapy designed to target toxic forms of beta-amyloid associated with AD. While recent FDA-approved passive immunotherapies have validated beta-amyloid as a target for AD treatment, Vaxxinity says that they are associated with imaging abnormalities and require frequent intravenous infusions. In contrast, the company says that UB-311 offers potential advantages, such as less frequent dosing, easier administration through intramuscular injection, and improved cost-effectiveness, which could increase patient accessibility.

“This publication supports the innovative work that we and our collaborators are conducting to advance UB-311 for the potential treatment, and even prevention, of Alzheimer’s disease,” said Mei Mei Hu, CEO of Vaxxinity. “Imagine expanding the addressable patient population of beta-amyloid immunotherapies by multiple orders of magnitude, potentially over 1,000x, and delivering life-changing medicine at a fraction of the cost. That is our vision for UB-311 and the potential power of active immunotherapies.”

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Photograph: Vaxxinity