Michael J. Fox Foundation Funds Parkinson’s Disease Vaccine Candidate

Vaxxinity, Inc. recently announced positive results from Part B of its Phase 1 clinical trial of UB-312, an investigational vaccine for Parkinson's disease (PD).

On June 22, 2023, the Company confirmed in a press release that UB-312 was well-tolerated and induced anti-alpha-synuclein (aSyn) antibody responses in participants with early PD, meeting the trial's primary objectives.

UB-312 is an investigational synthetic peptide vaccine targeting toxic aggregated aSyn forms to address PD and other synucleinopathies. Alpha-synuclein plays a central role in synaptic functions and regulation of neurotransmitter release.

The accumulation and aggregation of misfolded aSyn in the brain are key factors in PD's development and progression.

"This positive Phase 1 results demonstrate several important features necessary for an immunotherapy against Parkinson's disease and other synucleinopathies to be successful and represent a further proof-of-principle for Vaxxinity's platform in chronic disease," said Mei Mei Hu, CEO of Vaxxinity.

"UB-312 was observed to safely break immune tolerance, inducing antibodies against toxic aggregated forms of alpha-synuclein."

"Importantly, these antibodies crossed the blood-brain barrier, and the data also suggest potential target engagement in the periphery, where pathological alpha-synuclein is known to be concentrated."

"Together, these results support the further development of UB-312 in a Phase 2 clinical trial."

"We continue to view UB-312 as a promising candidate for the prevention or disease modification of Parkinson's disease globally."

This announcement is important since PD affects approximately one million people in the U.S. and more than 10 million worldwide.

The U.S. NIH says PD is a chronic brain and progressive neurodegenerative disorder that affects predominately dopamine-producing neurons in the substantia nigra area of the brain. 

Additionally, The Michael J. Fox Foundation is funding a 2-year collaborative project between Vaxxinity, the Mayo Clinic, and the University of Texas Houston. This work evaluates the potential of protein misfolding cyclic amplification to assess target engagement and will also aim to characterize the anti-aSyn antibodies produced after UB-312 administration.