Vaxxinity Announces Publication of UB-311 Safety, Tolerability, Immunogenicity, and Clinical Efficacy Data from Phase 2a Trial in Alzheimer’s Disease

Phase 2a data published in The Lancet’s eBioMedicine supports further development of UB-311

The paper concludes that UB-311 is the most advanced active immunotherapy targeting beta-amyloid in the clinic

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, and potentially lower rates of ARIA-E

CAPE CANAVERAL, Fla., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of medicines, today 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 (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, 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 Aβ. UB-311 was generally well-tolerated, with no cases of ARIA-E and limited cases of asymptomatic ARIA-H.