Second generation COVID-19 vaccine on the Vaccibody platform

Since December 2019, the SARS-CoV-2 coronavirus has caused over 770 million cases and over 7 million deaths. At the start of the epidemic, there was a great need for vaccines that could prevent infection, serious illness or death. Nykode Therapeutics ASA (formerly Vaccibody AS) had previously developed a DNA-based vaccine technology that targets antigens to antigen-presenting cells in the body to provide a stronger and faster immune response, and before the epidemic had developed two cancer vaccine candidates based on this platform. In 2020, Nykode set itself the goal of developing a competitive second-generation preventive vaccine against COVID-19, and designing this based on our advanced bioinformatics analyzes and molecular design. Several candidates were designed and evaluated experimentally, and these were shown to stimulate rapid and sustained functional antibodies and appropriate T-cell responses in animals. The candidate that was selected for clinical testing is based on the Spike protein from the South African virus variant B.1.351 after promising data in mice. VB10.2129 was then produced under "good manufacturing practice" (GMP), and a clinical trial with this vaccine was carried out in Norway in the period 2021-22. This was a dose-escalation study among healthy adult volunteers, and the main objective of the study was to investigate the safety, secondly the immune response generated by the vaccine (NCT05069623). This project has contributed to developing and evaluating a new COVID-19 candidate and at the same time generating new inventions, and created valuable data in humans for use of the technology platform from Nykode.