Vaxxinity Announces Positive Target Engagement Data from Phase 1 Clinical Trial for Parkinson’s Disease at AD/PD 2024

UB-312 is first immunotherapy to show reduction of pathological alpha-synuclein in cerebrospinal fluid of Parkinson’s patients

LISBON, Portugal, March 07, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (NASDAQ: VAXX), a U.S. company pioneering the development of a new class of medicines, announced positive clinical data from its UB-312 program in Parkinson’s disease (PD) presented by Jean-Cosme Dodart, PhD, SVP of Research at Vaxxinity in an oral session at the AD/PD 2024 International Conference on Alzheimer’s and Parkinson’s Disease, held virtually and in Lisbon, Portugal from March 5 to March 9, 2024. UB-312 is the first active immunotherapy candidate to show reduction of pathological alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) of PD patients.

UB-312 is designed to target aggregated forms of aSyn, the toxic species that underlies PD and other synucleinopathies. As part of the randomized, double-blind, placebo-controlled Phase 1 clinical 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 assess target engagement.

The UB-312-induced antibodies showed preferential binding to aggregated aSyn and almost no binding to normal monomeric aSyn, as measured by dot blot. After a single priming regimen, those treated with UB-312 in the 300/100/100µg dosing group showed a 20% decrease from baseline in aggregated aSyn in the CSF compared to a 3% increase in the placebo group (p<0.05), as measured by a Seed Amplification Assay (SAA). Further, a post hoc analysis showed that patients with detectable UB-312-induced antibodies in the CSF exhibited improvement in activities of daily living as measured by the MDS-UPDRS II clinical scale (p<0.01). These data also suggest a correlation between reduction in aggregated aSyn in the brain and change in MDS-UPDRS II (R=0.52, p=0.001).

“What we see from our UB-312 program is the potential to change the whole conversation around Parkinson’s treatment and prevention,” says Lou Reese, Co-Founder and Executive Chairman of Vaxxinity. “Our findings suggest UB-312 could transform Parkinson’s care, offering hope for improved outcomes with a disease-modifying treatment. The future isn’t decades away: today’s Parkinson’s patients may have hope for the near, not distant future.”