Immunization Strategy as a Potential Approach to Slowing Cognitive Decline in AD: Jean-Cosme Dodart, PhD

WATCH TIME: 9 minutes

"The paper that was published includes all the methods and data that we collected in a phase 2 clinical trial in early Alzheimer disease. We designed the trial well; it was a very small cohort that led to very encouraging results. We tried 2 different treatment regimens of the same dose of our vaccine and we confirmed that first it was safe and well tolerated."

UB-311 (Vaxxinity), a synthetic, peptide-based active immunotherapy, is designed to combat toxic amyloid-ß oligomers and fibrils, with potential benefits for patients with Alzheimer disease (AD). These benefits encompass reduction in incidence of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), convenience because of less frequent dosing, and simplicity of administration through intramuscular injection. Furthermore, the vaccine therapy aims to elevate both patient access and cost-effectiveness, which can be also beneficial for both patients and healthcare systems.¹

Vaxxinity’s phase 2 study (NCT02551809), recently published in Lancet Neurology, assessed UB-311 among individuals with mild AD and demonstrated a safe and tolerable profile, with positive trends on several secondary outcomes of cognitive, functional, behavioral, and global assessments.² Performed in Taiwan, the randomized, double-blind, placebo-controlled, parallel-group study randomly assigned 43 individuals with mild AD 1:1:1 to receive either 7 intramuscular injections of UB-311 (Q3M arm), 5 doses of UB-311 with 2 doses of placebo (Q6M arm) or 7 doses of placebo.

Recently, Jean-Cosme Dodart, PhD, senior vice president of research, Vaxxinity, sat down in an interview with NeurologyLive® to discuss how using a vaccine approach for AD is different from other traditional monoclonal antibody treatments. He also talked about the main findings from the phase 2 clinical trial investigating UB-311 as a potential treatment for AD, as well as shared future plans are for advancing the therapy in its clinical development.

REFERENCES
1. Vaxxinity announces publication of UB-311 safety, tolerability, immunogenicity, and clinical efficacy data from phase 2a trial in Alzheimer disease. News release. August 10, 2023. Accessed August 16, 2023. https://www.globenewswire.com/news-release/2023/08/10/2722636/0/en/Vaxxinity-Announces-Publication-of-UB-311-Safety-Tolerability-Immunogenicity-and-Clinical-Efficacy-Data-from-Phase-2a-Trial-in-Alzheimer-s-Disease.html#:~:text=(Nasdaq%3A%20VAXX)%2C%20a,clinical%20data%20demonstrating%20a%20trend
2. Yu HJ, Dickson SP, Wang P, et al. Safety, tolerability, immunogenicity, and efficacy of UB-311 in participants with mild Alzheimer’s disease: a randomized, double-blind, placebo-controlled, phase 2a study. The Lancet. 2023;94:104665. Doi:10.1016/j.ebiom.2023.104665