MinervaX, a privately held Danish biotech company, announces today that is has been awarded an investment of 3.6 mEUR from the Novo Holdings REPAIR Impact Fund for development of therapies to combat antimicrobial resistance (AMR). An additional investment of 0.8 mEUR was obtained from SunStone Capital. The funding will be used to help finalize Phase I development of the Company’s protein-only GBS vaccine, targeting pregnant women for the prevention of life-threatening infections in newborns.
GBS is responsible for 50% of life-threatening infections in newborns and affects 0.5-3 in 1,000 babies, depending on the geographical region. At any given time, some 15-25% of women are spontaneously colonized with GBS, and they run the risk of transmitting the bacteria to their child in the womb, during birth and/or during the first months of life. GBS infection in the unborn child may lead to premature delivery or stillbirth, and GBS infection in the newborn child may result in sepsis, pneumonia or meningitis, all of which carry a significant risk of severe morbidity, long-term disability or death. Annually, GBS is estimated to be responsible for some 57,000 cases of stillbirth, 319,000 cases of invasive neonatal disease, 7,000 cases of meningitis, and up to 3.5 million preterm deliveries globally.
MinervaX is developing a GBS vaccine for maternal immunization, likely to have superior characteristics compared with other GBS vaccine candidates in development. The latter are based on traditional capsular polysaccharide (CPS) conjugate technology. By contrast, MinervaX’s vaccine is a protein-only vaccine based on fusions of highly immunogenic and protective protein domains from selected surface proteins of GBS (the Alpha-like protein family). Given the broad distribution of proteins contained in the vaccine on GBS strains globally, it is expected that MinervaX’s vaccine will confer protection against almost 100% of GBS isolates.
MinervaX has previously reported positive results from an initial Phase I trial completed in 240 healthy adult women with a single component vaccine. The vaccine was demonstrated to have a favorable safety profile, give rise to high levels of long-lasting antibodies, which are capable of killing GBS bacteria and prevent invasion of epithelial and endothelial cell barriers. The current funding will be used to conduct a short Phase I trial to expand the coverage of the vaccine to close to 100% of all colonizing and invasive strains of GBS, by inclusion of a second vaccine component. In addition, funding will be used for CMC development in preparation of Phase II clinical trials. The clinical trial was initiated in the UK on January 8, 2019.
According to Per Fischer, D.Phil., Chief Executive Officer of MinervaX, “The award from the REPAIR Impact Fund, represents external validation and recognition of MinervaX’s GBS vaccine program by a group of key vaccine and bacteriology experts, and allows the company to advance the program towards Phase II clinical trials.”