MinervaX, a privately-held Danish biotechnology company developing a vaccine against Group B Streptococcus (GBS), and Wacker Biotech, a CDMO, agreed to collaborate on the manufacture of MinervaX’s active protein ingredients of its GBS vaccine.
GBS reportedly is responsible for nearly 50% of all life-threatening infections in newborns. At any given time, some 15–25% of the population, including pregnant people are spontaneously colonized with GBS, and during pregnancy they run the risk of transmitting the bacteria to their child in the womb, during birth and/or during the first months of life.
GBS colonization may lead to late abortions, premature delivery, or stillbirth and in the newborn child, may result in sepsis, pneumonia, or meningitis, all of which carry a significant risk of severe morbidity, long-term disability or death. There is no general implemented and fully protective preventative treatment available for GBS.
Older adults and adults with certain co-morbidities such as diabetes or obesity are also at an increased risk of severe GBS infections and form a second population which would benefit from a prophylactic vaccine against this potentially fatal disease.
Positive data
MinervaX’s lead vaccine candidate, is a novel protein-only vaccine, based on fusions of highly immunogenic and proactive protein domains from selected surface proteins of GBS. The company has successfully completed two Phase II clinical trials of its maternal vaccine against GBS and is in preparation to begin Phase III clinical trials in this indication.
Data from MinervaX’s GBS vaccine is positive, demonstrating an acceptable safety profile in pregnant people and their infants, with high immunogenicity, leading to functionally active antibodies, with the potential for broad coverage and protection, alleviating the need for excessive use of antibiotics, according to MinervaX.
Wacker Biotech will manufacture the active ingredients of MinervaX’s vaccine candidate, alongside performing the technology transfer, process validation, and process characterization activities for later commercial manufacturing. Subsequently, Wacker Biotech will perform all key functions critical to ensure stable commercial supply at its site in Amsterdam.
“Following the EUR 54 million financing last year, our team is advancing the development of our novel prophylactic vaccine against GBS for the benefit of all populations at risk, worldwide. Wacker Biotech is a robust manufacturing partner with a strong track record in late clinical and commercial supply and we look forward to collaborating with the team ahead of commencing Phase III studies,” said Per Fischer, CEO of MinervaX.
“With our strong background in E. coli processes, process characterization, and process validation experiences, we at Wacker Biotech are perfectly suited to support MinervaX with its ongoing program for the prevention of invasive GBS disease,” added Ronald Eulenberger, managing director of Wacker Biotech in Amsterdam.
Details of MinervaX’s completed Phase II clinical trials in pregnant people can be found at clinicaltrials.gov under the identifiers NCT04596878 and NCT05154578. In addition to pregnant people, MinervaX is also pursuing Phase I development of its novel GBS vaccine in older adults.
