MinervaX and Wacker Biotech Partner on Group B Strep Vaccine Production

COPENHAGEN, Denmark and MUNICH, Germany, September 17, 2024 – MinervaX ApS, a Danish biotechnology company focusing on developing a novel vaccine against Group B Streptococcus (GBS), has partnered with Wacker Biotech, a CDMO and subsidiary of Wacker Chemie AG, to produce key protein ingredients for MinervaX's GBS vaccine.

GBS is a significant cause of severe infections in newborns, being responsible for around half of all life-threatening infections in this vulnerable group. Approximately 15-25% of the general population, including pregnant individuals, are carriers of GBS. During pregnancy, there is a risk of transmitting this bacterium to the fetus, which can lead to severe outcomes such as late-term abortions, preterm delivery, or stillbirth. Newborns infected with GBS may develop serious conditions such as sepsis, pneumonia, or meningitis, which come with high risks of severe health issues, long-term disabilities, or even death. There is currently no universally implemented and fully effective preventive treatment for GBS, highlighting the urgent need for a vaccine to prevent adverse pregnancy outcomes and life-threatening infections in infants. Additionally, older adults and those with certain health conditions like diabetes or obesity are at increased risk of severe GBS infections, making them another critical group that could benefit from such a vaccine.

MinervaX's leading vaccine candidate is a protein-only vaccine derived from highly immunogenic protein domains from surface proteins of GBS. The company is dedicated to advancing this vaccine and has successfully concluded two Phase II clinical trials for maternal immunization against GBS. Preparations are underway for Phase III clinical trials. Data from these trials have shown promising results, with the vaccine displaying an acceptable safety profile in pregnant individuals and their infants, along with high immunogenicity. These outcomes suggest that the vaccine can induce functionally active antibodies with the potential for wide-ranging protection, which could reduce the current dependence on antibiotics.

Wacker Biotech will be responsible for producing the active ingredients of MinervaX’s vaccine candidate. This includes managing the technology transfer, process validation, and characterization necessary for subsequent commercial production. Wacker Biotech will ensure a consistent commercial supply from its facility in Amsterdam, The Netherlands.

Per Fischer, CEO of MinervaX, expressed the significance of this collaboration, stating, "GBS poses a life-threatening risk to newborns and is associated with over half a million premature births annually. After securing EUR 54 million in funding last year, we are moving forward with the development of our innovative prophylactic vaccine for the benefit of at-risk populations globally. Wacker Biotech is a reliable manufacturing partner with a solid history in clinical and commercial supply, and we look forward to working together as we prepare for Phase III trials."

Ronald Eulenberger, Managing Director of Wacker Biotech B.V., commented, "With our extensive expertise in E. coli processes, process characterization, and validation, Wacker Biotech is well-equipped to support MinervaX in its program aimed at preventing invasive GBS disease."

MinervaX's completed Phase II clinical trials in pregnant individuals are documented under the identifiers NCT04596878 and NCT05154578 on clinicaltrials.gov. Additionally, the company is pursuing Phase I development of the GBS vaccine for older adults, under identifier NCT05782179.