Vaxxinity’s Cholesterol Vaccine Candidate Successfully Lowers LDL-C: Preclinical Data Published

Vaxxinity, Inc. recently announced the publication of data from multiple non-human primate studies demonstrating that VXX-401 reproducibly lowers low-density lipoprotein cholesterol (LDL-C) in non-human primates. The results, which support the continued clinical development of VXX-401 as a candidate for the treatment of hypercholesterolemia and prevention of atherosclerotic cardiovascular disease, were published in the Journal of Lipid Research.

VXX-401 is a synthetic peptide vaccine designed to stimulate the immune system to produce antibodies targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), which reduce circulating LDL-C by inhibiting the breakdown of low density lipoprotein receptor (LDLR). High LDL-C is a major risk factor for coronary heart disease, heart attack, and stroke, and atherosclerosis is the leading cause of disease burden globally. Previous studies have demonstrated that blocking PCSK9 yields lower LDL-C levels and reduces the risk of adverse cardiovascular events.

Across three separate preclinical studies in cynomolgus monkeys, VXX-401 induced a strong and durable antibody response against PCSK9, and robust, sustained reduction of LDL-C over time. Prolonged exposure with VXX-401 resulted in an average of 44% LDL-C reduction. VXX-401 was well tolerated and did not induce any toxicity nor pathology beyond mild injection site reactions. These results suggest that VXX-401 could be a safe and effective anti-PCSK9 immunotherapy.

“Vaxxinity is committed to providing scalable, accessible, game-changing solution for worldwide heart health,” said Mei Mei Hu, CEO of Vaxxinity. “Despite multiple approved medications for LDL-C reduction, heart disease remains the number one killer in the world. A cholesterol vaccine like VXX-401 may provide a cost-effective and widely deployable solution that could potentially benefit hundreds of millions of people at risk. A well tolerated intervention that people can start early in life, and remain on for many years, lowering the cholesterol ‘area under the curve,’ has the potential to help us win the fight against heart disease.”

VXX-401 is currently in a Phase 1 clinical trial for safety and tolerability. Vaxxinity is on track to report initial topline data in mid-2024. More information about the trial is available at clinicaltrials.gov using Identifier NCT05762276.

VXX-401 was designed using Vaxxinity’s proprietary synthetic peptide vaccine platform and is being developed for the treatment of hypercholesterolemia. The platform is designed to harness the immune system to convert the body into its own natural “drug factory,” stimulating the production of antibodies. VXX-401 is designed to induce robust, long-acting antibodies against PCSK9 and lower LDL cholesterol to prevent or treat coronary heart disease.

Vaxxinity, Inc. is a purpose-driven biotechnology company committed to democratizing healthcare across the globe. The company is pioneering a new class of medicines 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 synthetic peptide immunotherapy candidates designed to bring the efficiency of vaccines to the treatment of chronic diseases, including Alzheimer’s disease, Parkinson’s disease, 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, visit http://www.vaxxinity.com.