Vaxxinity, Inc.’s ( VAXX Quick Quote VAXX - Free Report) shares rose 29.7% after it announced that it has initiated part B of the phase I study that is evaluating UB-312, its investigational immunotherapeutic vaccine, in patients with Parkinson’s Disease (PD).
UB-312 is a synthetic peptide vaccine developed to target toxic forms of α-synuclein (aSyn) proteins in the brain, which, if left untreated, increases the risk of acquiring PD.
Vaxxinity has designed the phase I study to evaluate the safety, tolerability and immunogenicity of UB-312 in PD. While part A of the study evaluated the vaccine in healthy participants, part B of the study will evaluate UB-312 in PD patients.
We note that the dosing of patients in Part B was initiated after the completion of the part A portion of the study. Data from part A of the study demonstrated that treatment with UB-312 produced sustainable and sufficient antibody levels against toxic aSyn proteins to cross the blood brain barrier at meaningful levels of approximately 0.2%. UB-312 had a well-tolerated safety profile at multiple dose levels.
Part B of the study will enroll up to 20 patients and consist of two cohorts to assess the safety and immunogenicity of the vaccine. The study will also explore biomarker endpoints for target engagements like Protein Misfolding Cyclic Amplification in PD patients.
Vaxxinity’s shares have plunged 54.3% in the trailing 12 months in comparison with the
industry’s 31.4% decline. Image Source: Zacks Investment Research
Per management estimates, approximately a million people in the United States and more than 10 million people globally suffer from PD. Although medications are available for PD, they are designed to counter the symptoms of the indication and become less effective over the course of time. The successful development of a disease modifying vaccine like UB-312 will help meet the needs of this uncatered population.
Apart from PD, UB-312 is also being developed for two other indications, dementia with Lewy Body (DLB) and multiple system atrophy (MSA), which result from an aggregation of toxic aSyn. In fact, the European Medical Agency has granted orphan designation to Vaxxinity’s UCB-312 in MSA indication.
Apart from UB-312, Vaxxinity is developing vaccines for other indications. The company is evaluating UB-612 and UB-311 vaccine candidates for COVID-19 and Alzheimer’s disease in early- and mid-stage clinical studies. Vaxxinity is also developing vaccines for hypercholesterolemia and migraines.
We remind investors that Vaxxinity began trading on the NASDAQ on Nov 11, 2021.
Zacks Rank & Key Picks
Vaxxinitycarries a Zacks Rank #3 (Hold) at present. Some better-ranked stocks in the overall healthcare sector include
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