Nykode aims to generate game changing therapeutics to treat cancers and auto-immune diseases with a high unmet medical need. The unique and innovate modular vaccine technology specifically targets antigens to antigen-presenting cells, that are essential to induce rapid, strong and long-lasting immune responses. 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, and autoimmune disorders.
The vaccine is delivered as a DNA plasmid, encoding the protein of interest. The DNA format is especially well suited for platform product development, as different DNA plasmids can be produced using a standardized process. A standardized process optimized for high yield of high quality Nykode plasmids with well characterized and robust process steps and aligned analytical methods will significantly reduce both time and cost to advance new vaccine candidates to clinical stage. In-house process expertise enables effective screening and troubleshooting of new product candidates before implementation at the CDMO, reducing the risk of not meeting product quality standards, sufficient drug volumes or project timelines. Furthermore, full ownership of the manufacturing process increases Nykode’s manufacturing flexibility as the process can be transferred to any contract manufacturing organization (CMO) without concerns for high licencing fees. From a regulatory perspective, the general risks with respect to process challenges and delays are also reduced when the company has one regulatory approved manufacturing process. Lastly, a high yielding and cost-effective manufacturing process may in the end also reduce the commercial vaccine cost and make the vaccines available for larger population.
The project goal has been to develop a standardized manufacturing process and analytical methods for Nykode plasmids that can support shorter timelines from lead candidate decision until first in human. Hence, the manufacturing process should be suitable for a large range of plasmids and only require minor adjustments for new products. The manufacturing process should also be scalable to accommodate late phase clinical trials and commercial setting. Additionally, the plasmid backbone itself also presents opportunities for optimizing elements which may influence efficacy and safety.
The project has successfully accomplished all milestones set forth in the original plans. A manufacturing process was developed, implemented at large manufacturing scale at two contract manufacturing (CMO) partners in Europe and USA and used to supply vaccine to clinical trials. The product quality was well within all specifications for clinical use and has been approved for use in clinical trials by several regulatory authorities. New improved plasmids were designed and are undergoing testing for use as a 2nd generation plasmid for new Nykode vaccine products.
The IPN project has overall brought high value to Nykode.
The development of a new, efficient platform manufacturing process for Nykode’s products may also present an opportunity for the biotech industry in Norway and potentially also pharmaceutical manufacturing within the country. The bioprocess development expertise gained during this project can support future establishment of both R&D and commercial-scale production domestically. This advancement could drive substantial economic growth, create new jobs, and stimulate increased activity in related sectors, such as equipment, consumables, clinical and regulatory services. Nykode has through the IPN project built strong relationships with the project partners and expanded its collaborations to include additional projects. Nykode has also increased the international network by engaging with several new CROs in addition to establishing a strategic partnership with a CMO during this project.
The development of a platform technology manufacturing process and implementation at a CMO partner has high value to Nykode.
A well-known manufacturing process optimized for Nykode plasmid products with standardized, optimized, characterized and robust process steps and aligned analytical methods will significantly reduce both time and cost to advance new vaccine candidates to clinical stage. Firstly, it eliminates the need to customize the CMOs process for every new product. Secondly, in-house expertise in this standardized process enables effective screening and troubleshooting of new product candidates, reducing the risk of implementation issues at the CMO, such as failures to meet product quality standards, achieve necessary volumes, or stay on clinical timelines.
From a regulatory perspective, the risk is also reduced when the company has one regulatory approved manufacturing process. Additionally, this process can be transferred to any new CMO facility without incurring licensing fees, which are often substantial when using a CMO-owned process
The strategic importance of having a fully Nykode owned standardized drug substance process extends further: It strengthens Nykode’s negotiation power vs third party suppliers, supports the potential to commercialize an internal manufacturing capacity as well as the ability to establish strategic clinical and commercial partnerships. Additionally, it strengthens Nykode’s negotiation position with CMOs, allowing the company to obtain lower manufacturing prices and secure slot reservations with more flexibility.
Lastly, A high-yield process also has the potential to lower commercial vaccine COGS and the cost of a commercial vaccine product, making it available to a broader patient population.
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.