Vaxxinity, a “purpose-driven biotechnology company committed to democratizing healthcare across the globe,” announced that it has dosed its first patient with Parkinson’s disease in a Phase 1 study of the vaccine UB-312.
UB-312 stimulates the body to produce antibodies against misfolded alpha-synuclein, a protein implicated in neurodegeneration in diseases like Parkinson’s and other synucleinopathies. In a preclinical trial, UB-312 prevented the accumulation of alpha-synuclein and improved motor function in a mouse model of synucleinopathies.
Part A of the Phase 1 trial, which tested the vaccine in 40 healthy volunteers, showed that UB-312 was safe and well tolerated and that it effectively crossed the blood-brain barrier. Part B is now enrolling patients in the early to moderate stages of Parkinson’s disease and will evaluate the immunogenicity and safety of the vaccine. Additionally, in collaboration with Mayo Clinic and the University of Texas and with support from the Michael J. Fox Foundation, Vaxxinity will perform protein misfolding cyclic amplification to determine how well UB-312 breaks down alpha-synuclein.
UB-312 was granted orphan drug status for multiple system atrophy by the European Medicines Agency and will also be evaluated in dementia with Lewy bodies.