Back to top

Image: Bigstock

Vaxxinity (VAXX) Starts Dosing in Parkinson's Disease Study

Read MoreHide Full Article

Vaxxinity, Inc.’s (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.

Zacks Investment ResearchImage 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 Alkermes (ALKS - Free Report) , BioNTech (BNTX - Free Report) and Vir Biotechnology (VIR - Free Report) , each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ earnings per share estimates for 2022 have increased from $0.70 to $0.71 in the past 30 days. Shares of Alkermes have risen 11% in the past year.

Earnings of Alkermes beat estimates in all the last four quarters, delivering a surprise of 147%, on average.

BioNTech’s earnings per share estimates for 2022 have increased from $30.97 to $32.52 in the past 30 days. Shares of BioNTech have risen 115.3% in the past year.

Earnings of BioNTech beat estimates in all the last four quarters, delivering a surprise of 132.4%, on average.

Vir Biotechnology’s bottom-line estimates for 2022 have been revised from a loss of $0.01 per share to earnings of $4.77 in the past 30 days. Shares of Vir Biotechnology have risen 12.5% in the past year.

Earnings of Vir Biotechnology beat estimates in two of the last four quarters while missing on the other two occasions, delivering a surprise of 13%, on average.