Date: 2014-10-22
Type of information: Collaboration agreement
Compound: Ebola vaccine
Company: Bavarian Nordic (Denmark) National Institute of Allergy and Infectious Diseases (NIAID) (USA) J&J (USA - NJ)
Therapeutic area: Infectious diseases
Type agreement: collaboration
Action mechanism: The regimen consists of two vaccine components that are based on AdVac® technology from Crucell Holland, which is part of the Janssen Pharmaceutical Companies, and the MVA-BN® technology from Bavarian Nordic. The research collaboration for a monovalent vaccine targeting the Zaire strain of the Ebola virus is part of an ongoing development program for a multivalent vaccine against other virus strains that cause disease in humans, including Ebola and Marburg viruses.
Disease: Ebola fever
Details: * On September 4, 2014, Bavarian Nordic announced that it will accelerate its collaboration with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), on the development of its Ebola vaccine programs. Bavarian Nordic and partners are planning to initiate the first trial of a promising combination vaccine regimen in humans in 2015. Bavarian Nordic has worked with NIAID for several years to advance its MVA-BN® technology to develop a combined vaccine against Ebola and Marburg viruses, both of which are high-priority biological agents. A recent study, conducted under NIAID\'s vaccine preclinical services program, demonstrated proof of concept for a prime-boost regimen of two vaccines based on Bavarian Nordic\'s MVA-BN technology and Crucell\'s (part of the Janssen Pharmaceutical companies of Johnson & Johnson) AdVac® technology respectively. Results from the study show complete protection against the highly virulent Ebola Zaire species, which is responsible for the current outbreak in West Africa. Planning is ongoing to accelerate the development of this combination vaccine regimen with the initiation of a trial in humans, anticipated in 2015. Bavarian Nordic is concurrently developing additional Ebola vaccine candidates, which are in preclinical testing. Among these candidates is a multivalent vaccine that protects against the two major strains of Ebola (Zaire and Sudan) as well as Marburg. The Company is also in discussions with the NIAID to accelerate the development of this multivalent vaccine into a clinical Phase 1 study in the next 12 months.
Financial terms: In September, Johnson & Johnson and Bavarian Nordic first announced they would fast-track the development and clinical testing of the vaccine program, which features a prime-boost regimen in which one vector is used to prime and the other to boost the immune response. The program has received direct funding from, and is also using, preclinical services from the NIAID, part of NIH under Contract Numbers HHSN272200800056C, HHSN272201000006I and HHSN272201200003I. Preclinical experiments conducted at the NIH of the combination vaccine regimen demonstrated that when both vaccines were administered two months apart, complete protection was achieved against the Kikwit Zaire strain of Ebola, which is highly similar to the virus that is the cause of the current outbreak in Western Africa.
Latest news: * On October 22, 2014, Johnson & Johnson announced that it has made a commitment of up to $200 million to accelerate and significantly expand the production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies. The company is closely collaborating with the World Health Organization (WHO), the National Institute of Allergy and Infectious Diseases (NIAID), as well as other key stakeholders, governments, and public health authorities on the clinical testing, development, production and distribution of the vaccine regimen. This combination vaccine regimen has shown promising results in preclinical studies, and is now planned to be tested for safety and immunogenicity in healthy volunteers in Europe, the United States of America and Africa starting in early January. Janssen is targeting production of more than one million doses of the vaccine regimen in 2015, 250,000 of which are expected to be released for broad application in clinical trials by May 2015. As part of an overall commitment to advance innovations that address unmet medical needs worldwide, a team of dedicated experts has been assigned to focus on bringing this preventative vaccine to people in need. The commitment by Johnson & Johnson includes an equity investment in Bavarian Nordic to provide capital for the development, testing and production of Bavarian Nordic's vaccine. Janssen will take the lead in funding and developing both components of the combination vaccine regimen.
