Vaxxinity announces publication of Phase 2 trial of UB-311

Vaxxinity announced the print publication of Phase 2a clinical trial data in The Lancet’s eBioMedicine, stating that UB-311 “was safe and well-tolerated,” with early clinical data demonstrating a trend for slowing cognitive decline in mild Alzheimer’s disease. UB-311 is a synthetic, peptide-based active immunotherapy that targets toxic beta-amyloid (Abeta) oligomers and fibrils and oligomers. The Phase 2a data, which have been previously disclosed, describe the safety, tolerability, immunogenicity, and early clinical efficacy of UB-311 when evaluated with quarterly or biannual booster doses. 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 Abeta. UB-311 was generally well-tolerated, with no cases of ARIA-E and limited cases of asymptomatic ARIA-H. “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.” Although the trial was not powered to make conclusions about efficacy, secondary efficacy outcomes on cognitive, functional, behavioral, and global assessments such as ADAS-Cog, MMSE, ADCS-ADL and CDR-SB were evaluated. Trends of slowing disease progression were observed across key cognitive and functional measures for UB-311-treated versus placebo-treated participants over 78 weeks of observation, including a 48% slowing of decline on CDR-SB in the UB-311 quarterly boosting group.