Cholesterol Vaccine Candidate Successfully Lowers LDL-C

Vaxxinity, Inc. announced today that it has published data from multiple non-human primate studies that demonstrate the VXX-401 vaccine candidate consistently reduces low-density lipoprotein cholesterol (LDL-C) in non-human primates.

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 reduces circulating LDL-C by inhibiting the breakdown of low-density lipoprotein receptor (LDLR).

Across three 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 or pathology beyond mild injection site reactions.

Previous studies have demonstrated that blocking PCSK9 yields lower LDL-C levels and reduces the risk of adverse cardiovascular events.

The company says these results suggest that VXX-401 could be a safe and effective anti-PCSK9 immunotherapy.

The first-in-human Phase 1 clinical trial of VXX-401 is ongoing, with topline results expected in mid-2024.

"Vaxxinity is committed to providing scalable, accessible, game-changing solutions for worldwide heart health," said Mei Mei Hu, CEO of Vaxxinity, in a press release on February 15, 2024.

"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 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."

The publication can be found in the Journal of Lipid Research (Volume 65, Issue 2, 100497, February 2024).