UB-311 Vaccine Candidate 2023
Vaxxinity Inc.'s UB-311 is a fully synthetic peptide-based active immunotherapy candidate that employs the UBITh® platform technologies to target aggregated forms of beta-amyloid (AB). The UBITh platform can generate a high-precision molecular vaccine with a high responder rate, strong on-target immunogenicity, and potential for cognition improvement, which supports UB-311 for active immunotherapy in early-to-mild AD patients. UB-311 targets the brain's toxic forms of aggregated Aβ (oligomers and fibrils and oligomers) to fight Alzheimer's disease (AD). Phase 1, Phase 2a, and Phase 2a LTE trials have shown UB-311 to be well tolerated in early AD subjects over three years of repeat dosing, with a safety profile comparable to placebo, with no cases of amyloid-related imaging abnormalities-edema (ARIA-E) in the main study. The Vaxxine Platform is designed to harness the immune system to convert the body into its own natural "drug factory," stimulating the production of antibodies.
UB-311 received the U.S. FDA Fast Track Designation for Alzheimer's Disease on May 2, 2022. The FDA's determination that UB-311 could potentially address a serious unmet medical need was based on preclinical and clinical data in AD patients. This designation will facilitate the development and expedite the review of UB-311. On August 10, 2023, Vaxxinity announced the 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 AD.
Florida-based Vaxxinity, Inc. (NASDAQ: VAXX) is a purpose-driven biotechnology company committed to democratizing healthcare globally. The company is pioneering a new class of synthetic, peptide-based immunotherapeutic vaccines to disrupt the existing treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer from prohibitive costs and cumbersome administration.
UB-311 is indicated for treating Alzheimer's disease (AD), the most common form of dementia. AD is a progressive neurodegenerative disorder that slowly destroys memory, cognitive skills, and the ability to carry out simple tasks. The exact cause of AD is unknown, but genetic and environmental factors are contributors. AD affects more than six million people in the United States and 44 million worldwide.
UB-311 is administered as an intramuscular injection.
UB-311 Vaccine Candidate News
August 10, 2023 - Jeffrey Cummings, M.D., Ph.D., Director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada, Las Vegas, and co-author of the paper, commented in a press release, "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."
May 2, 2022 - "We are excited that the U.S. FDA has granted UB-311 Fast Track Designation, as it recognizes the evidence demonstrating the potential for UB-311 to address a serious unmet medical need for patients with Alzheimer's disease," said Mei Mei Hu, CEO of Vaxxinity.
March 24, 2022 - Vaxxinity Corporate Overview presentation was posted.
April 14, 2017 - The AZ Association published: UB-311, a novel UBITh® amyloid β peptide vaccine for mild Alzheimer's disease. UB-311 reduced the levels of Aβ1-42 oligomers, protofibrils, and plaque load in hAPP751 transgenic mice in a clinical trial. Safe and well-tolerated UB-311 generated considerable site-specific (Aβ1-10) antibodies across all animal species examined. In AD patients, UB-311 induced a 100% responder rate; injection site swelling and agitation were the most common adverse events (4/19 each). A slower rate of increase in ADAS-Cog from baseline to week 48 was observed in the subgroup of mild AD patients (MMSE ≥ 20) compared with the moderate AD subgroup, suggesting that UB-311 may have a potential for cognition improvement in patients with early stage of Alzheimer's dementia.
UB-311 Vaccine Clinical Trial
Clinical Trial NCT03531710: An Extension Study of a Phase IIa Study in Patients With Mild Alzheimer's Disease to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311). The top-line Phase 2a data met the primary aims of safety and immunogenicity with a 96% response rate. In addition, all secondary endpoints - including Amyloid PET burden, CDR-SB, ADCS-ADL, ADAS-Cog, and MMSE - pointed directionally in favor of UB-311, though not statistically significant with the study sample size.