Vaxxinity’s Cholesterol Vaccine Candidate Successfully Lowers LDL-C

Preclinical Data Published

Preclinical data published in the Journal of Lipid Research indicate VXX-401 is well-tolerated, with no safety signals observed, and robustly reduces LDL-C in cynomolgus monkeys.

A Phase 1 trial of VXX-401 is ongoing, with topline results expected mid-2024.

CAPE CANAVERAL, Fla., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of medicines, today 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 (Volume 65, Issue 2, 100497, February 2024).

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.ⁱ Previous studies have demonstrated that blocking PCSK9 yields lower LDL-C levels and reduces the risk of adverse cardiovascular events.^{ii iii}  

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.”