The coronavirus SARS-CoV-2 has caused over 250 million cases and over 5 million deaths since December 2019, and there is still an urgent need for vaccines able to prevent disease and transmission and take into account the virus evolution. Nykode (previously Vaccibody AS) is a biopharmaceutical company dedicated to the discovery and development of novel immunotherapies for cancer and infectious diseases. Nykode has demonstrated that its cancer vaccine candidates were able to stimulate rapid and strong T cell responses in humans and will now develop this technology platform tailored for product development for infectious diseases. Nykode will develop a competitive second-generation preventive vaccine against COVID-19 and design this based on our advanced bioinformatic analyses and molecular design. Substantial preclinical research has been undertaken in 2020 and 2021 demonstrating the ability of COVID-19 vaccine candidates to induce rapid and persistent functional antibodies and appropriate T cell responses.
Trial material to be used in a first in human trial in Norway has been manufactured and the first clinical trial investigating the COVID-19 candidate in humans was initiated in November 2021 (NCT05069623). The clinical trial will study safety and evaluate the immune response to the vaccine. The expectation is that this project will help develop a unique vaccine candidate for COVID-19 and at the same time generate valuable data in humans for an infectious disease vaccine based on the technology platform from Nykode.
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.