MinervaX ApS, a Danish biotechnology company developing a prophylactic vaccine against Group B Streptococcus (GBS) and Wacker Biotech, a CDMO, entered a collaboration for the manufacture MinervaX’s active protein ingredients of its GBS vaccine.
 
GBS is responsible for nearly 50 percent of all life-threatening infections in newborns. 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 or long- term disability. There is not currently a fully protective preventative treatment available for GBS. Additionally, older adults and adults with certain co-morbidities also at an increased risk of severe GBS infections.
 
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 preparing to begin Phase III trials in this indication. Data from MinervaX’s GBS vaccine is very 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.
 
MinervaX is also pursuing Phase I development of its GBS vaccine in older adults.
 
Wacker Biotech will manufacture the active ingredients of MinervaX’s novel vaccine candidate, alongside performing the technology transfer, process validation and process characterization activities for later commercial manufacturing. Wacker Biotech will then perform all key functions critical to ensure stable commercial supply at its site in Amsterdam, The Netherlands.
 
Per Fischer, CEO of MinervaX, said, “GBS can be life-threatening for newborn babies and is linked to over half a million preterm births annually. 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.”
 
Ronald Eulenberger, Managing Director of Wacker Biotech B.V. in Amsterdam, said, “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.”