The two-pronged mission of the Novo Nordisk Foundation Initiative for Vaccines & Immunity (NIVI) is to generate knowledge on host immunity, host-pathogen interactions, and vaccine technologies, and translate this knowledge into vaccines that provide robust, durable, and broad immunity against respiratory pathogens.
This will be achieved by anchoring NIVI’s research activities within the Novo Nordisk Foundation Center for Vaccines & Immunity, or NCVI), and simultaneously establishing a limited liability company wholly owned by the Foundation (the Novo Nordisk Foundation Vaccine Accelerator, or NVAC). Within this configuration, multidisciplinary NIVI project teams will collaborate closely on technology development, key data generation, and overall progress towards developing new vaccines.
A key role for NVAC will be to catalyze progress towards achieving the NIVI mission by enabling access to cutting edge technologies needed to facilitate the Initiative’s comparative, data-driven approach to design, test, and optimize novel vaccine candidates. NVAC will also provide capabilities and expertise (either directly, or via external strategic partnerships) to ensure the full value chain, from exploratory research to clinical Phase 2 translational development, can be achieved.
The three main objectives for NVAC are:
- To enable key research by in-licensing IP
NIVI will require a broad portfolio of diverse vaccine platforms, as well as ensure access to a state-of-the-art ‘adjuvant toolbox’ through dedicated strategic partnerships. To enable this, NVAC will have an expert team that will evaluate potential promising IP and negotiate business terms to acquire and develop vaccine technologies (including antigens, delivery systems, adjuvants and vaccine platforms) for dedicated translational research activities. The overall aim is to ensure IP/technologies are available to NCVI researchers for evaluation, combination, and optimization with the aim to develop novel vaccines against the NIVI pathogens and generate comprehensive comparative datasets on different vaccine platforms.
- Optimize early process development and technology transfer
NVAC will ensure that quality considerations are implemented and documented from early discovery by 1) providing high quality reagents and analytical assays for the NCVI research teams, 2) optimizing small-scale manufacturing, purification, and formulation, 3) overseeing technology transfer to a production partner that can scale up and manufacture vaccine candidates under GMP for Phase 1 and 2 clinical trials, and 4) validating assays that can be used in clinical trials.
- Oversee advanced vaccine development, clinical testing, and out-licensing of lead vaccine candidates
If NIVI’s research results in a lead vaccine candidate with promising data, a professional vaccine development team will develop a detailed proposal and budget for advanced vaccine development and clinical testing. NVAC will then coordinate the production of GMP-certified vaccines and oversee Phase 1 and 2 clinical trials in collaboration with dedicated clinical trial partners. Once NIVI has a promising lead vaccine candidate with supporting clinical trial data, the vaccine package including intellectual property (IP) rights, preclinical/clinical data, and manufacturing know-how will be out-licensed to a commercial partner for further clinical development, large-scale manufacturing, and marketing under relevant global access and revenue sharing agreements. Any revenue will be reinvested in NIVI.
