Site-specific UBITh® amyloid-β vaccine for immunotherapy of Alzheimer's disease

The UBITh® AD immunotherapeutic vaccine for Alzheimer's disease uses an amyloid-β (Aβ) immunogen having two designer peptides that have been engineered to elicit anti-N terminal Aβ1–14 antibodies while minimizing potential for the generation of adverse anti-Aβ immune responses. The vaccine has been further designed for minimization of inflammatory reactivities through the use of a proprietary vaccine delivery system that biases Th2 type regulatory T cell responses in preference to Th1 pro-inflammatory T cell responses. In vitro studies and in vivo studies in small animals, baboons and macaques show that anti-Aβ antibodies are generated with the expected N-terminus site-specificity, and that these antibodies have functional immunogenicities to neutralize the toxic activity of Aβ and promote clearance of plaque deposition. The antibodies appear to draw Aβ from the CNS into peripheral circulation. Results indicate that the UBITh® AD vaccine did not evoke anti-Aβ cellular responses in a transgenic mouse model for AD. The vaccine was safe and well tolerated in adult Cynomolgus macaques during a repeat dose acute and chronic toxicity study.