Statens Serum Institute

Pictured: Novo Nordisk Foundation in Copenhagen, Denmark/iStock, CR The Novo Nordisk Foundation on Monday announced a $260 million commitment to launch a research and vaccine development initiative, taking aim at some of the deadliest respiratory diseases like tuberculosis and influenza. The vaccine initiative will be the first to focus specifically on understanding how to elicit immunity in the airway, providing a “potentially revolutionary” approach to blocking respiratory infections and preventing their airborne transmission between humans, according to Monday’s announcement. The R&D effort, which will be called the Novo Nordisk Foundation Initiative for Vaccines and Immunity (NIVI), will begin in the first quarter of 2024 and will be run in partnership with the University of Copenhagen and Denmark’s Statens Serum Institut. Novo Nordisk Foundation CEO Mads Krogsgaard Thomsen said in a statement that the COVID-19 pandemic showed the “extraordinary possibilities” in vaccine development and advancements when the industry commits its focus and resources to interdisciplinary research. With NIVI, the Novo Nordisk Foundation and its partners are “building on that momentum and dreaming even bigger—working towards a world where respiratory diseases no longer end the lives of millions of people every year,” Krogsgaard Thomsen said. NIVI will first focus on three respiratory infections—tuberculosis, influenza and Group A Streptococcus—developing novel vaccines for these diseases that elicit robust local immunity, in turn minimizing their transmission and the spread of antimicrobial resistance. The effort will also consider the potential vaccine antigens, platforms and delivery methods to increase the chance of a successful candidate, according to the announcement. To ensure that its basic vaccine research can smoothly transition into clinical development, NIVI will have a unique structure, comprised of two separate and synergistic entities. The first, dubbed the Novo Nordisk Foundation Center for Vaccines and Immunity (NCVI), will carry out the bulk of its research activities and will be housed at the University of Copenhagen’s Department of Immunology and Microbiology. The second entity is a limited liability company called the Novo Nordisk Foundation Vaccine Accelerator (NVAC), which will license and develop vaccine technologies and prepare the formulations, reagents and assays, as well as coordinate clinical-grade production and testing of potential candidates. To ensure the close integration of NCVI and NVAC, these two entities will be led by NIVI’s CEO and executive director, who will be announced early next year. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

COPENHAGEN, Denmark, Dec. 18, 2023 /PRNewswire/ -- The Novo Nordisk Foundation is committing up to DKK 1.8 billion (USD 260 million) to establish a state-of-the-art research and vaccine development initiative. The aim is to create new or improved vaccines for some of the deadliest respiratory diseases, including tuberculosis (TB) and influenza. Developed in partnership with the University of Copenhagen, it is the first vaccines initiative globally to focus solely on understanding how to generate immunity in the airway itself. This is a potentially revolutionary means to block infection and prevent airborne diseases spreading between humans. A key partner in the initiative will be Denmark's Statens Serum Institut (SSI). Research at the Novo Nordisk Foundation Initiative for Vaccines and Immunity (NIVI) will focus initially on TB, influenza and Group A Streptococcus (GAS), which collectively cause more than 2.5 million deaths per year. There is currently no licensed GAS vaccine, while the only available TB vaccine does not prevent lung disease in adolescents and adults, and influenza vaccines have limited efficacy and provide only short-term protection. Professor Mads Krogsgaard Thomsen, CEO of the Novo Nordisk Foundation, sees great potential for NIVI, both in Denmark and globally. "The development of the Covid-19 vaccines demonstrated the extraordinary possibilities when interdisciplinary vaccine research and development are prioritised," says Krogsgaard Thomsen. "With NIVI, the Novo Nordisk Foundation and the University of Copenhagen are building on that momentum and dreaming even bigger – working towards a world where respiratory diseases no longer end the lives of millions of people every year. "Here in Denmark, NIVI will consolidate current expertise in immunology and vaccine development, helping to establish an internationally renowned vaccine research system and ensuring that Denmark is at the forefront of translational vaccine science globally." Developing vaccines and advancing knowledge Conventional vaccine design and testing typically focus on generating a systemic immune response that prevents severe disease or death. However, recipients can still get infected and pass the disease to other people. Vaccines that generate a local immune response at the site of infection – in the case of respiratory diseases, in the airways – could help prevent even mild infection, block transmission and generate long-term immunity. This could significantly reduce deaths and the burden on healthcare systems around the world. NIVI aims to develop new vaccines for TB, influenza and GAS that generate robust, local immunity in the airways and, by extension, limit the spread of antimicrobial resistance, a global pandemic driven in part by the overuse or misuse of antibiotics against airway infections. Furthermore, while most vaccine development initiatives focus on a single strategy, NIVI will compare different vaccine antigens, platforms, and delivery methods side by side, increasing the chances of success. In the case of delivery methods, for example, various strategies will be tested and combined, including conventional injection in the muscle and nasal sprays. By studying three very different viral and bacterial diseases and developing a range of vaccine candidates and technologies, NIVI will significantly advance understanding of both systemic and airway immunity, helping the world to tackle existing and future airborne threats. Bridging research and vaccine development NIVI has a unique structure among vaccine initiatives. It comprises two entities, which together will ensure a smooth path between basic research and vaccine development up to Phase II clinical trials. The research arm – the Novo Nordisk Foundation Center for Vaccines and Immunity (NCVI) – is funded via an eight-year grant and anchored in the Department of Immunology and Microbiology at the University of Copenhagen, which has gained global recognition for its expertise in infectious disease, immunology and technological innovation. "Basic research carries great importance when it comes to the health and well-being of the world's population – both present and future," says Dean Bente M. Stallknecht from the Faculty of Health and Medical Sciences, University of Copenhagen. "Vaccines and knowledge of immunology is a key part of that. Boosting excellent basic research within this field of research will pave the way for new discoveries and hold potential to make a huge difference to so many people all round the globe." She also stresses the importance of creating translational pathways that lead from basic science into impact: "We are proud that we, as a faculty and university, are involved in setting up new types of initiatives specifically designed to foster translational research. One of our finest tasks as researchers and as a university is to make our research come to life and be of use, and this is what we can do with a structure like NIVI and the link-up between university and industry." To this end, the Foundation has also established a limited liability company – the Novo Nordisk Foundation Vaccine Accelerator (NVAC P/S). NVAC will enable and enhance the work of NCVI by licensing and developing vaccine technologies, preparing vaccine formulations, reagents and assays, and coordinating the external clinical-grade production and clinical testing of promising vaccine candidates. Any revenue generated by NVAC will be reinvested in NIVI. National and international partnerships Collaboration with public and private actors will be crucial to the initiative's success. A key partner will be Statens Serum Institut (SSI), which operates under the auspices of the Danish Ministry of the Interior and Health. SSI has substantial expertise in vaccine design and development, and highly relevant research programs and infrastructure. "Vaccine research is crucial to ensure that we have the best possible protection against diseases in the future," says Sophie Løhde, Minister of the Interior and Health. "There is a need for innovative solutions and public-private partnerships that can help improve vaccine research and thus public health globally. I am therefore pleased that the Novo Nordisk Foundation, in collaboration with the University of Copenhagen and Statens Serum Institut, will contribute to strengthening Denmark's position as a leader in vaccine research and development." National and international partnerships with world-leading research teams and experts with similar ambitions will also be established in the coming years, while NVAC will seek manufacturing partnerships to ensure that promising new vaccines have real-world impact and are accessible and affordable. NCVI and NVAC will be headed by the same person – the NIVI Executive Director/CEO, to be announced in 2024 – with the dual role ensuring close integration of the two entities. Until now, development of NIVI has been led by eminent vaccinologist and Senior Vice President of Infectious Diseases at the Novo Nordisk Foundation, Professor Peter Lawætz Andersen. "Fundamentally, designing vaccines with a focus on generating immunity in the respiratory system is a relatively unexplored area of research with astounding potential," he says. "We hope that NIVI's work can help prepare us for the next pandemic or even help consign airborne epidemics to history." About the Novo Nordisk Foundation Initiative for Vaccines and Immunity (NIVI) The development of NIVI is planned in two phases. Phase I (2024-2027) will involve staff recruitment, the development of new international partnerships, and the initiation of key research programmes. By Phase II (2028-2031), NIVI will be fully scaled and comprise 150-200 staff members based in Copenhagen. About the Novo Nordisk Foundation Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people's health and the sustainability of society and the planet. The Foundation's mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society. SOURCE Novo Nordisk Foundation

Dive Brief:The Novo Nordisk Foundation, which owns a controlling stake in drugmaker Novo Nordisk, said Monday it will invest 1.8 billion Danish kroner, or about $260 million, to fund development of new vaccines for respiratory diseases.The new initiative will study ways to build immunity at the site of infection inside airways for diseases like tuberculosis, influenza and group A streptococcus, which the foundation says collectively cause more than 2.5 million deaths annually.Dubbed the Novo Nordisk Foundation Initiative for Vaccines and Immunity, the program will test new vaccine targets and methods of delivery alongside each other, rather than focus on only one approach. The initiative will consist of a research center and an accelerator that together will support the translation of basic research through to mid-stage clinical testing.Dive Insight:Novo Nordisk has been buoyed by the success of its in-demand diabetes and weight loss medicines, despite manufacturing issues that have slowed sales.The companys boom is lifting its parent Novo Holdings, which is wholly owned by the Novo Nordisk Foundation. In October, the CEO of Novo Holdings said he expected to funnel the windfall from Ozempic and Wegovy into other intiatives. Now, the Foundation, alongside the University of Copenhagen, is unveiling a major new vaccine program.A research center, which is funded via an eight-year grant, will conduct basic research, while a limited liability company will handle licensing vaccine technologies and coordinating clinical testing of any potential candidates. Any revenue generated by the accelerator will be reinvested back into the program.The goal is to find vaccines that build immunity in the airways, rather than systemically, which could help prevent infection and block transmission.Both group A streptococcus and tuberculosis can be treated with antibiotics. However, antimicrobial resistance is a growing public threat, with tuberculosis a major contributor. The only available tuberculosis vaccine doesnt prevent lung disease in teenagers and adults, meanwhile.No vaccine is available for group A streptococcus. While flu vaccines are available, there are still gaps in protection that drugmakers are working to fill with their own shots.The fast progress made on vaccines for COVID-19 helped catalyze the foundations new initiative.While [COVID vaccines] did save countless lives, they werent able to stop infection or transmission, said Peter Lawtz Andersen, head of infectious diseases at the Novo Nordisk Foundation in a statement to BioPharma Dive. In this way, the COVID experience exposed the major limitation of current vaccines against respiratory pathogens that they generate a systemic immune response, not a response at the site of infection.The initiative will partner with the Danish research institute Statens Serum Institut, and draw on the University of Copenhagen. '