Vaccine successfully lowers cholesterol in preclinical studies

Cardiovascular system

New studies have demonstrated that Vaxxinity’s vaccine VXX-401 reproducibly lowers low-density lipoprotein cholesterol (LDL-C) in non-human primates.

The results support the continued clinical development of VXX-401 as a candidate for the treatment of hypercholesterolemia and prevention of atherosclerotic cardiovascular disease.

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.

Mei Mei Hu, CEO of Vaxxinity, said: “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 I clinical trial for safety and tolerability, with topline data expected in mid-2024.

Diana Spencer, Senior Digital Content Editor, DDW

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