Immunotherapeutic vaccine company Vaxxinity Inc. (VAXX:NASDAQ), which is engaged in developing vaccines to treat neurodegenerative, chronic and infectious diseases, today announced that "the first patient with Parkinson's disease (PD) has been dosed with UB-312 in Part B of a double-blinded, placebo-controlled Phase 1 clinical trial, following completion of Part A of the Phase 1 trial in healthy volunteers."
The firm indicated that "UB-312 is a synthetic peptide vaccine targeting toxic forms of aggregated α-synuclein (aSyn), a protein that plays a central role in synaptic functions and regulation of neurotransmitter release at the synapse."
The company explained additionally that, "mutations of aSyn increase the risk of developing PD and other synucleinopathies, including dementia with Lewy bodies (DLB) as well as multiple system atrophy (MSA)."
Vaxxinity advised the European Medical Agency (EMA) has previously issued UB-312 orphan designation for use in MSA.
The company's CEO Mei Mei Hu commented, "We are delighted to achieve another milestone for Vaxxinity as we initiate the next part of our clinical program in Parkinson's, an indication with clear unmet needs for a large patient population…Part A of our Phase 1 study demonstrated that UB-312 was generally safe and well tolerated at multiple dose levels, and that it successfully generated robust levels of titers against aggregated aSyn that crossed the blood brain barrier at meaningful levels of approximately 0.2%. "
The report stated that the ongoing study, which is being conducted in the Netherlands at the Center for Human Drug Research, will enroll up to 20 patients who have been previously diagnosed with PD, Hoehn and Yahr stage ≤ III. The participants will be split into two groups with the primary goal of determining the safety and immunogenicity of UB-312. In addition, Vaxxinity advised that the study will also investigate potential biomarker endpoints for target engagement including Protein Misfolding Cyclic Amplification. The study is backed by a grant from the Michael J. Fox Foundation and is being carried out in partnership with both the Mayo Clinic and the University of Texas.
The report explained that Parkinson's disease affects around one million people in the U.S. and greater than ten million globally. The chronic and progressive neurodegenerative condition affects predominately dopamine-producing neurons in the substantia nigra area of the brain. At present, there are not any approved disease-modifying therapeutic treatments available.
Vaxxinity is a biotechnology company engaged in development of new classes of synthetic, peptide-based immunotherapeutic vaccines engineered to disrupt current standard approaches to treating chronic diseases. The firm noted that presently the field is increasingly centered around and dominated by monoclonal antibody treatments that are often cost prohibitive and difficult to administer.
The company's vaccine pipeline includes prospective treatments for chronic diseases such as Alzheimer's, hypercholesterolemia, migraine and Parkinson's. The firm is also utilizing its synthetic, modular technology in its phase 1 and phase 2 COVID-19 vaccine studies.
Vaxxinity started the day with a market cap of around $727.3 million with approximately 124.8 million shares outstanding. VAXX shares opened 4.5% higher today at $6.09 (+$0.26, +4.46%) over yesterday's $5.83 closing price. The stock has traded today between $6.01 and $7.46 per share and is currently trading at $7.20 (+$1.37, +23.50%).
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