Development of a highly efficient and robust manufacturing process for personalised and general DNA vaccines

The Vaccibody technology is a molecule delivered as a DNA plasmid, encoding a protein consisting of three functional units; a targeting unit that binds to surface receptors on antigen presenting cells, a dimerization unit and an antigenic unit that is derived from the disease-causing agent, e.g. from a cancer cell or pathogen. Targeting the antigens to the antigen presenting cells induces a fast, strong and long-lasting immune response particularly for the T-cells which distinguishes the Vaccibody product from conventional vaccines. This modular platform provides the opportunity to target multiple therapeutic areas spanning from personalized cancer vaccines to off-the-shelf vaccines within the field of cancer, infectious diseases as well as autoimmune disorders. In order to explore the technology platform in clinical studies and develop products suitable for commercialization within each disease area, a robust manufacturing process for high quality products is crucial. It is the goal of the current NFR project to develop a generic manufacturing process for all Vaccibody plasmid products that can bring the products quickly from research and into clinical studies, which is of particular importance to support manufacture readiness in case of a e.g. a pandemic situation. Hence, it should work across a large range of plasmid products and need only a minimal amount of adjustment for each product before manufacture in clinical scale. The manufacturing process should also be suitable for further scale up to larger production scales if necessary for area of use. A platform manufacturing process is currently established in lab scale for a range of plasmids and has been used to bring two Covid vaccines into clinical phase 1/2a in collaboration with our partners. The collaboration will continue to focus on the robustness of the process and scale up as well as exploring the suitability for even a wider range of plasmid products.

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Nykode is a clinical stage biotech company developing personalised and general therapeutic cancer and infectious vaccines VB10.GEN. The underlying idea of the proposed Innovation Project is to develop a highly efficient and robust production pipeline enabling robbust manufacturing of personalized and general DNA vaccines for use in patients with clear medical needs The overarching goal of the project is to enable a robust and more or less generic manufacturing process across the entire Nykode Portfolio. Regulatory authorities will be heavily involved as Nykode will seek support for the selected regulatory strategy to Ensure that all the therapies are developed in the best possible manner. In the current project there will be specific focus on the development of a generic and scalable process for the vaccine manufacture in addition to the cGMP manufacture of the vaccine itself. The advantage will be cost and time savings for all new projects and manufacturing readiness which is of huge importance in e.g. a pandemic situation. The quality of the product and safety of the patient cannot be compromised. Robustness and predictability throughout the supply chain will therefore be important read outs of the project. A proprietary manufacturing process for personalised and general pDNA cancer vaccines is of high strategic value to Nykode and will eventually lead to a cost effective, robust and rapid throughput of cancer and infectious vaccines.