Vaxxinity’s Cholesterol Vaccine Candidate Shown to Lower LDL-C in Preclinical Data

February 15, 2024—Vaxxinity, Inc. announced the publication of data demonstrating that the company’s VXX-401 reproducibly lowers low-density lipoprotein cholesterol (LDL-C) in nonhuman 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 reduce circulating LDL-C by inhibiting the breakdown of low-density lipoprotein receptor (LDLR).

The results from multiple studies support the continued clinical development of VXX-401 as a candidate for the treatment of hypercholesterolemia and prevention of atherosclerotic cardiovascular disease, stated the company.

Madeline M. Vroom, PhD, et al published the findings online in the Journal of Lipid Research.

According to Vaxxinity, three separate preclinical studies in cynomolgus monkeys showed that 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. Additionally, 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, advised the company.

VXX-401 is currently in a phase 1 clinical trial for safety and tolerability. The company is aiming to report initial topline data in mid-2024.

Vaxxinity stated that VXX-401, which is being developed for the treatment of hypercholesterolemia, was designed using the company’s synthetic peptide vaccine platform. The platform is designed to harness the immune system to stimulate 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.