Vaxxinity, Inc. announced the print publication of Phase 2a clinical trial data in The Lancet?s eBioMedicine (Volume 94, 104665, August 2023), 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 (AD). UB-311 is a synthetic, peptide-based active immunotherapy that targets toxic beta-amyloid (Aß) oligomers and fibrils and oligomers.

Two passive immunotherapies ? monoclonal antibodies (mAbs) targeting Aß ? have recently been authorized by the FDA, validating Aß as a target for disease-modifying immunotherapies of AD; however, these passive immunotherapies 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).1,2,3 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, 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; and overall improved accessibility and cost-effectiveness for patients and health systems. 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 Aß.

UB-311 was generally well-tolerated, with no cases of ARIA-E and limited cases of asymptomatic ARIA-H.