Vaxxinity’s cholesterol vaccine reduces LDL in primates

Promising preclinical results for cholesterol vaccine candidate boost hopes for treatment and prevention of heart disease.

Immunotherapeutic vaccine developer Vaxxinity has published promising preclinical data for its cholesterol vaccine candidate, VXX-401. The findings, published in the Journal of Lipid Research, demonstrate the vaccine reproducibly reduced low-density lipoprotein cholesterol (LDL-C) in non-human primates.

High LDL-C is recognized as a significant risk factor for coronary heart disease, heart attacks, and strokes. A candidate for the treatment of hypercholesterolemia and prevention of cardiovascular disease, VXX-401 is a synthetic peptide vaccine that targets a protein called PCSK9 to stimulate the immune system, triggering the production of antibodies that inhibit the breakdown of LDL receptors.

In three separate preclinical studies in monkeys, VXX-401 showcased a robust and lasting antibody response against PCSK9, leading to a sustained reduction of LDL-C by an average of 44%. Vaxxinity claims that results so far suggest that VXX-401 holds promise as an immunotherapy for combating PCSK9 and lowering LDL cholesterol, which would have potentially positive implications for the prevention and treatment of cardiovascular disease.

Vaxxinity's cholesterol vaccine reduces LDL in primates
Vaxxinity is led by CEO Mei Mei Hu.

VXX-401 is currently in a Phase 1 clinical trial to assess safety and tolerability in humans, which is expected to yield initial topline data by mid-2024.

“Despite multiple approved medications for LDL-C reduction, heart disease remains the number one killer in the world,” said Mei Mei Hu, CEO of Vaxxinity. “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.”

Vaxxinity is focused on developing synthetic peptide immunotherapy candidates, offering an alternative to existing therapies for conditions like Alzheimer’s disease, Parkinson’s disease, migraine, and hypercholesterolemia.

READ MORE: Could space travel research deliver a frailty vaccine?

Photograph: PhotobyTawat/Shutterstock