– DENMARK, Copenhagen – 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. An additional investment of 0.8 mEUR was obtained from Sunstone Life Science Ventures. 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 longlasting 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.”
Group B Strep Support is the UK’s only charity dedicated to eradicating group B Strep infection in newborn babies. Chief Executive and Founder of the charity, Jane Plumb MBE, welcomes the news that Phase 1 program of MinervaX’s clinical trial of their GBS vaccine will now be finalised ahead of Phase II trials.
“We welcome the news that MinervaX’s Phase 1 program of their group B Strep vaccine will be finalised thanks to funding from the REPAIR Impact Fund. Group B Strep is the most common cause of severe infection in newborn babies and of meningitis in babies under 3 months.
A safe and effective vaccine is the ‘holy grail’ of preventing group B Strep infection and could protect more than any other prevention strategy. It is urgently needed and I’m delighted that the research into MinervaX’s vaccine candidate will continue.”
Group B Strep International is a non-profit organization committed to promoting awareness and prevention of group B strep disease in babies during pregnancy through several months of age. Marti Perhach, CEO and Cofounder of GBSI, is glad to know that MinervaX has received funding from the REPAIR Impact Fund to finalize their Phase I clinical development of a GBS vaccine. “The current GBS disease prevention strategy of routine screening and indicated IV antibiotic treatment during labor and delivery adopted by many countries only targets GBS infections acquired during birth and, while highly effective, raises concerns about antibiotic overuse and how antibiotics affect the newborn’s microbiome. An effective GBS vaccine replacing this strategy would obviate these concerns as well as provide a measure of protective coverage for unborn babies nearing term and babies up to several months of age, both periods of susceptibility without health agency recommended prevention strategies.”
MinervaX is a Danish biotech company, established in 2010 in order to develop a prophylactic vaccine against Group B Streptococcus (GBS), based on research from Lund University. The company’s investors include Novo A/S (Denmark), Sunstone Life Science Ventures (Denmark), LF Investment (Denmark), Preseed Ventures A/S (formerly DTU Symbion Innovation A/S) and Lund University Innovation System (Sweden).
For more information : http://minervax.com
About REPAIR Impact Fund
The REPAIR Impact Fund, commissioned by the Novo Nordisk Foundation and operated by Novo Holdings, will invest in start-ups, early-stage companies and corporate spin-outs in Europe and the United States. It will give priority to first-in-class therapies, covering small molecules, biologics and new modalities, from the early stage of drug development (lead optimization) to the early stages of clinical development (Phase 1). It can invest as the sole investor or in a syndicate, with investments ranging from USD 1 million to USD 15 million.
The projects will be selected through an investment process with support of a highly qualified Scientific Selection Board, comprising 10 world-class experts.
For more information :
About Group B Strep Support
Group B Strep Support is a UK charity working to prevent preventable group B Strep infections in newborn babies.
For more information : https://www.gbss.org.uk
About Group B Strep International –
Group B Strep International is a U.S. based nonprofit organization promoting awareness and prevention of GBS disease in babies worldwide.
For more information : https://www.groupbstrepinternational.org
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