Parkinson’s Patients Treatment Posts Positive Engagement

Vaxxinity, Inc. today announced new data from an early-stage clinical trial demonstrating that antibodies derived from its investigational immunotherapeutic for Parkinson's disease, UB-312, slows the seeding of alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) of patients as demonstrated using multiple target engagement assays.

These data signify that UB-312 has established clear target engagement in Parkinson's disease (PD) patient CSF.

Jean-Cosme Dodart, Ph.D., SVP of Research at Vaxxinity, commented in an email, “The more data we see from our UB-312 program, the more excited I get for the future of this vaccine and its potential positive impacts for patients with PD or other a-synucleopathies."

"Demonstrating target engagement in PD patients immunized with UB-312 is an exciting milestone which encourages us to push this program further into clinical development.”

UB-312 is a UBITh®-enhanced synthetic peptide-based vaccine designed to target aggregated forms of aSyn, the toxic species that underlies PD and other synucleinopathies.

"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, in a press release on July 17, 2023.

"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 clinical 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."

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.

Mark Frasier, Ph.D., Chief Scientific Officer of MJFF, commented, "Integration of critical biomarker insight into therapeutic development programs is essential for building confidence in the treatment approach and designing informative trials. We're pleased to support efforts of this kind that can have a major impact for people with Parkinson's disease."