MinervaX and Wacker Biotech announced a collaboration to manufacture active protein ingredients for MinervaX’s Group B Streptococcus (GBS) vaccine in September 2024. The vaccine candidate is a novel protein-only vaccine, based on fusions of “highly immunogenic and proactive protein domains” from selected GBS surface proteins. Wacker Biotech is to manufacture the active ingredients and perform technology transfer, process validation, and process characterisation activities for commercial manufacturing. The organisation will also perform key functions to ensure “stable commercial supply” at its Amsterdam site.
GBS
Group B Streptococcus (GBS) is a “leading cause” of neonatal and infant sepsis and meningitis. The highest incidence is in neonates and young infants up to 3 months old. Between 15% and 25% of the population are “spontaneously colonised” with GBS, but during pregnancy this carries the risk of transmitting the bacteria to the child in the womb, during birth, and/or during the first months of life. WHO emphasises the need for an effective maternal GBS vaccine to protect neonates and infants before they can elicit and effective immune response.
MinervaX identifies an “unmet medical need” as there is no “general implemented and fully protective preventative treatment” for GBS. Furthermore, older adults and adults with some co-morbidities are at increased risk of severe GBS infections. This population would also benefit from a prophylactic vaccine.
A protein approach
MinervaX has developed a novel protein-only vaccine based on fusions of “highly immunogenic and protective protein domains” from the Alpha-like protein family (AlpN). This approach is intended to deliver a vaccine with “broad coverage and protection”. The lead candidate, AlpN GBS, comprises two fusion proteins, each containing two AlpN-terminal domains: GBS-NN (containing RibN and AlpCn) and GBS-NN2 (containing Alp1N and Alp2/3N).
Two Phase II clinical trials of the maternal vaccine have been successfully completed, and MinervaX is preparing for Phase III trials in this indication. Data are “very positive”, with an “acceptable” safety profile in pregnant participants and their infants, and “high immunogenicity”.
Joining forces
Dr Per Fischer, CEO of MinervaX, commented that GBS “can be life-threatening for newborn babies” and is associated with “over half a million preterm births annually”. However, after €54 million financing last year, the team is advancing the development of their novel prophylactic vaccine “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.”
Managing Director of Wacker Biotech B.V in Amsterdam, Ronald Eulenberger, looks forward to bringing Wacker Biotech’s strengths to the collaboration.
“With our strong background in E. coli processes, process characterisation, and process validation experiences, we at Wacker Biotech are perfectly suited to support MinervaX with its ongoing programme for the prevention of invasive GBS disease.”
We look forward to hearing from MinervaX’s CSO, Dr Bengt Johansson Lindbom, on a panel exploring the role of vaccines and mAbs in neonatal sepsis prevention at the Congress in Barcelona next month. Get your tickets to join us there and don’t forget to subscribe to our weekly newsletters for the latest vaccine news.
