DALLAS, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (NASDAQ: VAXX), a clinical-stage biotech company pioneering a new class of immunotherapeutic vaccines to treat and prevent chronic neurological diseases, including Alzheimer’s and Parkinson’s, has announced that the company has been awarded a grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) for the exploration of markers for target engagement in individuals with Parkinson’s disease (PD).
Vaxxinity is developing its PD vaccine candidate UB-312, which has completed Part A of a first-in-human study in healthy volunteers and is advancing to Part B in Parkinson’s patients. This award from MJFF will support the discovery and development of relevant pharmacodynamic markers. Specifically, the funds will be used to investigate whether Protein Misfolding Cyclic Amplification (PMCA) could be implemented as a robust method to assess target engagement in subjects immunized with UB-312. In recent years, PMCA has demonstrated excellent sensitivity and specificity for the detection of pathological forms of α-synuclein (aSyn) in the cerebrospinal fluid (CSF) of PD patients and has been shown to discriminate accurately between those with synucleinopathies, including PD and Multiple System Atrophy (MSA), versus healthy individuals.
UB-312 is designed to target pathological forms of aSyn for the treatment and prevention of synucleinopathies, including PD. UB-312 was selected as a clinical candidate through a comprehensive screening and profiling campaign, and demonstrated strong immunogenicity and efficacy in preclinical studies.
In the healthy volunteer portion of a first-in-human Phase 1 trial (Part A), UB-312 was found to be generally well tolerated at multiple dose levels. Serum and CSF anti-aSyn antibody titers were dose-dependent and indicated that antibodies crossed the blood-brain barrier (BBB) with a CSF:Serum ratio up to 0.2%.
Vaxxinity plans to initiate Part B of the Phase 1 trial later this month to assess the safety, tolerability, and immunogenicity of UB-312 in PD patients. Vaxxinity’s senior vice president of preclinical R&D, Jean-Cosme Dodart, PhD, will serve as principal investigator of the exploratory project funded by MJFF.
“By essentially turning the body into its own antibody manufacturer, our technology platform has the potential to truly disrupt and displace traditional biologics and mAbs with something that is accessible to everyone globally,” says Lou Reese, Executive Chairman of Vaxxinity. “With respect to neurodegenerative diseases, a vaccine approach further allows us to more efficiently go earlier into disease, halting progression before symptoms start or deteriorate.”
Mark Frasier, PhD, Co-Chief Scientific Officer of MJFF adds, “MJFF is proud to award this grant to Vaxxinity as they begin Part B of their Phase 1 trial of UB-312 in Parkinson’s patients. This trial of UB-312 presents an exciting opportunity to investigate PMCA as a method to assess the neutralization of alpha-synuclein, a potentially critical contribution to the advancement of our understanding of target engagement in Parkinson’s.”
As the world’s largest nonprofit funder of Parkinson’s research, MJFF is dedicated to finding a cure for Parkinson’s disease through an aggressively funded research agenda and to ensuring the development of improved therapies for those living with Parkinson’s today. The Foundation has funded nearly USD $1.5 billion in research to date. Operating at the hub of worldwide Parkinson’s research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders, increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder, promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.
Vaxxinity, Inc. is a purpose-driven biotechnology company committed to democratizing healthcare across the globe. The company is pioneering a new class of synthetic, peptide-based immunotherapeutic vaccines aimed at disrupting the existing treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer from prohibitive costs and cumbersome administration. The company’s proprietary technology platform has enabled the innovation of novel pipeline candidates designed to bring the efficiency of vaccines to the treatment of chronic diseases, including Alzheimer’s, Parkinson’s, migraine, and hypercholesterolemia. The technology is also implemented as part of a COVID-19 vaccine program. Vaxxinity has optimized its pipeline to achieve a potentially historic, global impact on human health. For more information about Vaxxinity, Inc., visit www.vaxxinity.com and follow us on social media @vaxxinity.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe," "may," “continue,” “advancing,” and "will" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Vaxxinity’s management about the development of a new class of immunotherapeutic vaccines and the innovation and efficacy of Vaxxinity’s product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on December 23, 2021. The forward-looking statements are made as of this date and Vaxxinity does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.