UB-311 Vaccine Candidate Description 2022
Vaxxinity's UB-311 is a fully synthetic vaccine candidate that employs the UBITh platform technologies to target aggregated forms of beta-amyloid. UB-311 targets toxic forms of aggregated Aβ in the brain to fight Alzheimer’s. 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. Highly immunogenic with a high responder rate and antibodies that bind to the desired target.
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 Alzheimer’s patients. This designation will facilitate the development and expedite the review of UB-311
Texas-based Vaxxinity, Inc. (NASDAQ: VAXX) is a purpose-driven biotechnology company committed to democratizing healthcare across the globe. 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 and cognitive skills and eventually the ability to carry out simple tasks. The exact cause of AD is unknown, but genetic and environmental factors are established 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
May 9, 2022 - Vaxxinity, Inc. reported financial results for the first quarter ended March 31, 2022; cash and cash equivalents were $124.8 million, as compared to $144.9 million on December 31, 2021.
May 2, 2022 - “We are excited that the 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, Chief Executive Officer of Vaxxinity.
March 24, 2022 - Vaxxinity Corporate Overview presentation.
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.