Vaxxinity Demonstrates Target Engagement of Toxic Alpha-Synuclein in Parkinson’s Patients

Disease-modifying candidate UB-312 demonstrated target engagement of aggregated alpha-synuclein in cerebrospinal fluid of Parkinson’s patients

Data provide validation of the Vaxxinity platform’s ability to selectively target aggregated, toxic forms of neurodegenerative proteins

CAPE CANAVERAL, Fla., July 17, 2023 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of medicines, today announced new data from a Phase 1 clinical trial demonstrating that antibodies derived from its investigational immunotherapeutic for Parkinson’s disease (PD), UB-312, slows seeding of alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) of patients with PD as demonstrated using multiple target engagement assays. These data signify that UB-312 has established clear target engagement in PD patient CSF, and provides further validation of Vaxxinity’s platform technology in neurodegenerative disease.

“This is a major milestone for Vaxxinity in our quest to help Parkinson’s patients.  Our candidate has shown target engagement of the toxic species of alpha-synuclein in patients, demonstrating not only proof of our technology platform, but also proof of the mechanism of our vaccine-derived antibodies specifically engaging with the toxic target in vivo,” said Mei Mei Hu, CEO of Vaxxinity.  “Showing target engagement has always been a key challenge to overcome in neurodegeneration, and is of critical importance when demonstrated – a milestone worth celebrating.  It is beyond our expectation to see this in our Phase 1 trial.  We are endlessly grateful to the patients who participated, and to The Michael J. Fox Foundation and our collaborators for their work on these cutting-edge assays that supported this breakthrough.”

UB-312 is designed to target aggregated forms of aSyn, the toxic species that underlies Parkinson’s disease and other synucleinopathies. Last month, Vaxxinity announced clinical data from Part B of its Phase 1 clinical trial of UB-312 demonstrating that UB-312 was well-tolerated and induced anti-aSyn antibody responses in participants with early PD, and that antibodies were detectable in the CSF. As part of this trial, The Michael J. Fox Foundation (MJFF) funded a 2-year collaborative project between Vaxxinity, the Mayo Clinic, and UTHealth Houston to analyze CSF collected from patients, and to conduct exploratory research to characterize the anti-aSyn antibodies produced after UB-312 administration and assess target engagement.