This collaboration is pivotal as GBS remains a significant cause of severe infections in newborns, accounting for nearly half of all life-threatening cases.
With 15-25% of the population, including pregnant individuals, at risk of GBS colonisation, the potential transmission to infants can lead to serious health complications such as sepsis, pneumonia, or meningitis. The absence of a widely implemented, fully protective treatment against GBS highlights the urgent need for a vaccine to prevent these adverse outcomes.
MinervaX’s lead vaccine candidate is a protein-only vaccine derived from immunogenic protein domains of GBS surface proteins.
The company has successfully completed two Phase II clinical trials of its maternal vaccine and is preparing for Phase III trials. The vaccine has shown promising results, demonstrating safety, high immunogenicity, and the potential to produce functionally active antibodies for broad coverage, thereby alleviating the need for excessive use of antibiotics.
Wacker Biotech will be responsible for manufacturing the vaccine’s active ingredients, conducting technology transfer, and ensuring process validation for commercial production. The manufacturing will take place at Wacker Biotech’s Amsterdam facility, where it will also manage the commercial supply after regulatory approval.
MinervaX CEO Per Fischer said: “GBS can be life-threatening for newborn babies and is linked to over half a million preterm births annually. Following the €54m 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.”
Wacker Biotech in Amsterdam managing director Ronald Eulenberger 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.”
In addition to targeting pregnant individuals, MinervaX is exploring the vaccine’s efficacy in older adults through Phase I development.