In June 2024 Vaxxinity announced the publication of “groundbreaking exploratory data” from a Phase I clinical trial of UB-312 in patients with Parkinson’s disease (PD). UB-312 is an active immunotherapy medicine (AIM) designed to “slow or stop” the progression of Parkinson’s by “addressing the root cause”. The trial was a 44-week, randomised, placebo-controlled, double-blind, single-centre Phase I study to investigate the safety, tolerability, and immunogenicity of UB-312.
Tackling the root cause
The authors state that Parkinson’s disease (PD) is “characterised by progressive deterioration of motor, cognitive, behavioural, and autonomic function”. While mechanisms of dopaminergic cell loss are “not fully understood”, it is known that α-synuclein (αSyn) has a “central role” in neurodegeneration, and the team believes that targeting pathological, aggregation-prone forms of αSyn has potential for therapeutic approaches.
UB-312 was chosen from over 60 synthetic peptide immunogens and has already demonstrated high immunogenicity in preclinical studies across species. Antibodies induced by UB-312 selectively targeted pathological oligomeric and fibrillar αSyn forms, binding specifically to αSyn inclusions in postmortem brain sections from patients with PD. Additionally, UB-312-derived antibodies demonstrated neuroprotective effects in vitro, reduced αSyn in the brain and gut, and prevented motor function deficits in a transgenic synucleinopathy mouse model.
The study
In Part A of the study, escalating doses of UB-312 were tested against a placebo in healthy volunteers aged 4-85 years, which suggested that it was “safe and well tolerated” up to 300/300/300 μg three-dose ‘prime-boost’ regimen. Prime-boost regimens of 300/100/100 μg and 300/300/300 μg were selected based on safety and immunogenicity profile for evaluation in patients with PD. This was followed by Part B, designed to assess the safety, tolerability, and immunogenicity of the two chosen UB-312 regimens in patients with PD.
The trial in patients with PD met the primary outcomes and showed that UB-312 was “generally safe and well tolerated” and generated a time-dependent increase in anti- αSyn antibodies in both serum and cerebrospinal fluid (CSF). Vaxxinity infers from this that UB-312 can “help to eliminate the buildup of harmful, toxic forms of the protein αSyn in the brain”. Patients with detectable UB-312-induced antibodies in CSF exhibited “significant improvement in motor experiences of daily living” according to the MDS-UPDRS Part II.
Leading the charge
Lou Reese, Co-Founder and Executive Chair of Vaxxinity, suggests that the publication of the team’s data “immortalises the profound impact of UB-312, leading the charge against the very core of Parkinson’s”.
“It sparks a beacon of hope and anticipation for a future where Parkinson’s no longer determines the trajectory of lives. This is more than just a scientific breakthrough; it’s a battle cry for change, declaring that the status quo in Parkinson’s care is no longer acceptable.”
Professor Geert Jan Groeneveld, neurologist and principal investigator of the trial at the Centre for Human Drug Research in Leiden, states that UB-312 “has the potential to become an important and potent disease-modifying therapy”.
“It would be truly amazing if we could vaccinate people against Parkinson’s disease in the future!”
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