UB-311 is a synthetic, peptide-based active immunotherapy that targets toxic beta-amyloid (Aβ) oligomers and fibrils and oligomers.
Two passive immunotherapies – monoclonal antibodies (mAbs) targeting Aβ – have recently been authorized by the FDA, validating Aβ as a target for disease-modifying immunotherapies of AD.
However, they have been associated with amyloid-related imaging abnormalities (ARIA), which can present as vasogenic edema or sulcal effusion (ARIA-E), or as hemosiderin deposits such as microhemorrhages and superficial siderosis (ARIA-H).
Furthermore, the FDA-licensed mAbs require IV infusions every two weeks, and are priced at $26,500 annually, which does not include the cost of administering them or monitoring for ARIA.
In contrast, Vaxxinity claims UB-311 has the potential to offer multiple competitive advantages, including lower rates of ARIA-E; improved convenience through less frequent dosing and ease of administration through intramuscular injection; as well as improved accessibility and cost-effectiveness.
The 78-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, study was conducted in Taiwan.
UB-311 elicited a robust, rapid, and titrated antibody response to Aβ and was generally well-tolerated, with no cases of ARIA-E and limited cases of asymptomatic ARIA-H.
Trends of slowing disease progression were also observed across key cognitive and functional measures for UB-311-treated versus placebo-treated participants.
Mei Mei Hu, CEO of Vaxxinity, said: “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."
“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.”
Jeffrey Cummings, director for transformative neuroscience at the University of Nevada and co-author of the paper, added: “The UB-311 Phase 2a program accomplished its goals of establishing safety and tolerability, while generating high levels of anti-amyloid antibodies.”
“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.”
