Naobios, a CDMO (Contract Development and Manufacturing Organization) which offers services for the process development and production according to GMP (Good Manufacturing Practices) of clinical batches of virus-based drugs, and the European Vaccine Initiative (EVI ), a leading European non-profit product development partnership, today announced a collaboration for the production of a respiratory syncytial virus (RSV) challenge agent. This is part of the Inno4Vac project, funded by the Innovative Health Initiative. Financial terms of the deal were not disclosed.
Naobios has already developed, produced and packaged several viral challenge agents or Human Viral Challenge Agents (HVCA) for study purposes for the global market. Studies using HVCAs are strictly controlled clinical trials (or CHIMs) in which volunteers are intentionally administered a carefully dosed pathogen in order to test a prophylactic vaccine or treatment. Naobios has a proven track record in this area, having successfully produced 15 GMP batches of various viral strains – including SARS-CoV-2, RSV and metapneumovirus (hMPV) – and leveraging this innovative approach to accelerate the process vaccine development.
“Our cutting-edge equipment and in-depth expertise in the production of challenge agents allow us to meet the demands of our customers around the world, advancing research and therapeutic development in virology,” said Eric Le Forestier, CEO of Naobios. “This partnership with EVI marks an important milestone in our mission to leverage HVCAs to accelerate the production of effective and accessible vaccines for regions of the world that struggle to prevent viral outbreaks. »
Once HVCA is produced, according to GMP standards, it plays a crucial role in CHIM testing. These studies, which are used in several countries, including the United States, the United Kingdom, the Netherlands and Belgium, make it possible to evaluate early and inexpensively the effectiveness of vaccines such as those to prevent RSV infection. This in turn helps accelerate the development of effective and affordable RSV vaccines.
In a 2019 study, the World Health Organization (WHO) found that RSV, an acute respiratory viral infection, was a leading cause of severe respiratory illness. According to this study, RSV is responsible for approximately 33 million cases of acute lower respiratory infections worldwide each year, leading to more than 3.2 million hospitalizations and up to 149,400 deaths per year, mainly in infants. Low- and middle-income countries, where RSV is very widespread, and particularly those in sub-Saharan Africa, would be the first beneficiaries with more quickly accessible vaccines.
“CHIM studies help shorten the traditional process of developing new vaccines and generate early evidence of their effectiveness,” adds Ole Olesen, Executive Director of EVI. “CHIM studies on RSV require high quality HVCA, and our collaboration with Naobios is therefore of major importance to the success of our projects. »
Source : Naobios
