Second generation COVID-19 vaccine on the Vaccibody platform

The coronavirus SARS-CoV-2 has caused over 770 million cases and over 7 million deaths since December 2019. At the outset of the epidemic, there was a critical need for vaccines to prevent infection and severe disease or death. Nykode Therapeutics ASA (formerly Vaccibody AS) had previously developed a DNA based vaccine technology that targets antigens to antigen presenting cells, to result in faster and stronger immune responses, and had prior to the epidemic developed two cancer vaccine candidates based on this platform. In 2020, Nykode set out to develop a competitive second generation preventive COVID-19 vaccine, and design this based on our advanced bioinformatic and molecular design toolbox. Several candidates were designed and evaluated experimentally, and these turned out to induce rapid and persistent antibody and appropriate T cell responses in animals. The candidate selected for clinical evaluation was based on the Spike protein from the South African virus variant B.1.351, after promising data in mice. VB10.2129 was thereafter manufactured under «good manufacturing practise» (GMP), and a clinical trial with this candidate performed in Norway during 2021-22. This was a dose-escalation study among healthy adult volunteers, and the main objective of the study was to evaluate the safety, thereafter the immune response generated by the vaccine (NCT05069623). This project has contributed to the development and evaluation of a new COVID-19 vaccine, generated new innovations and valuable data in humans on the Nykode technology platform.

- Responded to vaccine need in an epidemic situation utilizing our proprietary vaccine platform. - Dedicated full discovery project that rapidly developed a variant-adapted vaccine candidate - Developed a tailored GMP process and manufactured clinical batches for clinical trial use - Designed, organised and executed a clinical phase 1 trial in two sites in Norway in an accelerated manner - Gained learnings on epidemic response and tailoring of platform for novel antigens

Vaccibody is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies for cancer and infectious diseases. Vaccibody is in this project seeking to utilize the differentiating parameters of the Vaccibody technology platform into product development for infectious diseases by developing a competitive second generation preventive vaccine against COVID-19. We will develop pilot candidates based on proprietary bioinformatics algorithms and antigen delivery molecular construct designs, and demonstrate preclinical proof of concept by characterising immunogenicity in small animal models and protection in animal challenge models with live SARS-CoV-2 virus. Vaccibody has in 2020 performed substantial preclinical research resulting in COVID-19 vaccine candidates able to induce rapid and persistent functional antibodies and appropriate T cell responses. We will manufacture GMP batch of the lead candidate for use in phase 1/2 trials, undertake regulatory and clinical activities enabling phase 1 clinical trial first in man testing of a COVID-19 vaccine candidate to study safety and immunogenicity in the appropriate target population. Vaccibody finally anticipates that this will facilitate partnering for large scale access with external partners, bringing forward a novel vaccine candidate and broadening the platform capabilities in the field of infectious disease vaccines. We are here proposing to create potential value in terms of developing a lead candidate into clinical evaluation and offer this for partnering, through this provide evidence that the platform is competitive within infectious disease application, and to develop bioinformatic algorithms and design approaches that address the challenge of evolution within coronaviruses.