Vaxxinity shares update about potential vaccine UB-312
Phase 1 clinical trial results of UB-312 for Parkinson's expected this summer
Results from a Phase 1 clinical trial testing the experimental vaccine UB-312 in people with Parkinson’s disease are expected this summer, according to the therapy’s developer Vaxxinity.
“Vaxxinity remains on track to meet critical milestones in 2023,” Mei Mei Hu, the company’s CEO, said in a press release.
“Our well-capitalized position allows us to pursue multiple catalysts across our chronic disease pipeline, including Phase 1 trial data readouts for our investigational vaccines including UB-313 for migraine and UB-312 for Parkinson’s disease,” Hu said.
Parkinson’s is characterized by the formation of aggregates, or clumps, of the protein alpha-synuclein in brain cells. These protein clumps are toxic to brain cells and they can spread in a prion-like fashion — meaning that clumps in one cell can trigger clumps to form in neighboring cells. It’s thought that the spread of these toxic clumps through the brain is one of the major biological drivers of brain degeneration in Parkinson’s.
The UB-312 vaccine is designed to trigger the body’s immune system to make antibodies that will bind to the disease-associated form of the alpha-synuclein protein to stop its toxic clumping. The experimental vaccine is now being tested in a first-in-human Phase 1 clinical trial (NCT04075318), sponsored by Vaxxinity (formerly known as United Neuroscience).
The first part of the Phase 1 study enrolled 50 healthy adult volunteers, who were given a placebo or injections of UB-312 at doses ranging from 40 to 2,000 micrograms. Dosing of the highest amounts was stopped after a patient developed serious flu-like symptoms, but results showed that doses up to 300 micrograms were tolerated well, with the most common side effects being headache or injection site reactions (e.g., pain or tenderness) that resolved in time.
Results from the healthy volunteers also suggested that the experimental vaccine triggered the development of antibodies against alpha-synuclein as designed.
Study goals
Vaxxinity now has completed dosing in the second portion of the trial, which is testing UB-312 at doses of 100 or 300 micrograms in people with early or mild-to-moderate Parkinson’s disease. As with the initial segment in healthy volunteers, the main goals of this study are to assess the safety profile of the experimental vaccine and to test whether it can trigger antibodies as intended.