MinervaX and Wacker Biotech Collaborate to Advance Group B Streptococcus Vaccine Production
核心洞察
MinervaX (搜索) and Wacker Biotech (搜索) collaborate to scale up manufacturing of MinervaX's novel protein-only vaccine against Group B Streptococcus (搜索) (GBS (搜索)) in preparation for Phase III trials.
Wacker Biotech (搜索) will handle technology transfer, process validation, and commercial manufacturing of the vaccine's active protein ingredients at its Amsterdam facility.
The GBS (搜索) vaccine targets maternal immunization to prevent adverse pregnancy outcomes and life-threatening infections in newborns, addressing a critical unmet medical need.
MinervaX (搜索) ApS and Wacker Biotech (搜索) have announced a manufacturing collaboration to advance the production of MinervaX's novel prophylactic vaccine against Group B Streptococcus (搜索) (GBS (搜索)). This collaboration aims to scale up the supply of the vaccine's active protein ingredients in preparation for Phase III clinical trials.
GBS (搜索) is a significant cause of life-threatening infections in newborns, accounting for nearly 50% of such cases. Approximately 15-25% of the population, including pregnant individuals, are colonized with GBS, posing a risk of transmission to their children during pregnancy, birth, or the first months of life. GBS colonization can lead to late abortions, premature delivery, or stillbirth, and in newborns, it may result in sepsis (搜索), pneumonia (搜索), or meningitis (搜索), all carrying substantial risks of severe morbidity, long-term disability, or death.
Addressing Unmet Needs in GBS Prevention
Currently, there is no universally implemented and fully protective preventative treatment for GBS (搜索), highlighting the urgent need for a vaccine. MinervaX (搜索)'s vaccine aims to prevent adverse pregnancy outcomes and life-threatening infections in infants caused by GBS. Furthermore, older adults and individuals with comorbidities like diabetes (搜索) or obesity (搜索) are also at increased risk of severe GBS infections, making them another target population for prophylactic vaccination.
MinervaX (搜索)'s lead vaccine candidate is a protein-only vaccine based on fusions of highly immunogenic protein domains from GBS (搜索) surface proteins. The company has completed two Phase II clinical trials of its maternal vaccine against GBS and is preparing to initiate Phase III trials. The Phase II data showed an acceptable safety profile in pregnant individuals and their infants, along with high immunogenicity, leading to functionally active antibodies with the potential for broad coverage and protection, potentially reducing the need for excessive antibiotic use.
Manufacturing and Technology Transfer
Wacker Biotech (搜索) will manufacture the active ingredients of MinervaX (搜索)'s vaccine candidate, including technology transfer, process validation, and process characterization activities for commercial manufacturing. Wacker Biotech will perform key functions to ensure stable commercial supply at its Amsterdam site.
"GBS (搜索) can be life-threatening for newborn babies and is linked to over half a million preterm births annually," said Per Fischer, CEO of MinervaX (搜索). "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 (搜索) 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 (搜索) B.V. in Amsterdam, stated, "With our strong background in E. coli processes, process characterization, and process validation experiences, we at Wacker Biotech are perfectly suited to support MinervaX (搜索) with its ongoing program for the prevention of invasive GBS (搜索) disease."
Details of MinervaX (搜索)'s completed Phase II clinical trials in pregnant individuals can be found at clinicaltrials.gov under the identifiers NCT04596878 and NCT05154578. In addition to pregnant individuals, MinervaX is also pursuing Phase I development of its novel GBS (搜索) vaccine in older adults, under identifier NCT05782179.