Copenhagen, Denmark, 20 September 2022 – MinervaX, a privately held Danish biotechnology company today announces that EMA has awarded PRIME status for its vaccine against Group B Streptococcus (GBS).
PRIME is aimed at enhancing support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier.
MinervaX is developing a maternal vaccine for the prevention of adverse pregnancy outcomes and lifethreating infections caused by Group B streptococcus (GBS). GBS is responsible for nearly half of all lifethreatening infections in newborns during the first 3 months of life as well as a portion of late-term abortions, premature deliveries, or stillbirths during pregnancy. Current preventative strategy is insufficient, and great medical needs exist, which may be addressed by a maternal GBS vaccine. MinervaX’s maternal GBS vaccine is based on adjuvanted proteins antigens covering close to 100% of clinical GBS isolates.
EMA stated that.
- Invasive Group B streptococcus (GBS) disease has a substantial impact in terms of stillbirths, infant mortality due to sepsis and meningitis, and long-term sequelae. Despite screening programmes and antibiotic prophylaxis, there is still an unmet medical need.
- The available evidence is supportive of the promise to address the unmet need, as the vaccine has been shown to produce antibodies which are likely to cross the placenta, and which reach concentrations above the predicted Correlate of Protection. Ongoing company efforts aim at the essential process of validating this Correlate of Protection.
- The potential for prevention of late onset disease by the transfer of IgA antibodies to the newborn via breastfeeding is also noted.
Commenting on the announcement, Per Fischer, Chief Executive Officer of MinervaX, said: “We are very pleased with the award of PRIME status. This is a recognition of the high medical need for the vaccine and the promise that the vaccine offers. It will greatly facilitate interactions with and guidance from EMA for the development of this vaccine”
Gerd Zettlmeissl, Chairman of MinervaX Board of Directors said: “This is another important milestone in the very successful development of MinervaX‘s protein based GBS vaccine. I would like to thank the whole team for its professional and diligent work towards making this urgently needed product available to pregnant women.”
For more information on MinervaX, please contact:
Per Fischer, CEO
MinervaX is a Danish biotechnology company, established in 2010 to develop a prophylactic vaccine against Group B Streptococcus (GBS), based on research from Lund University. 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 virtually 100% of all GBS isolates. www.minervax.com
About Group B Streptococcus (GBS)
GBS is responsible for nearly 50% of all life-threatening infections in newborns. 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 colonization may lead to late abortions, premature delivery, or stillbirth and, 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.
Currently, the only preventative strategy available involves the use of intravenously delivered prophylactic antibiotics which does not comprehensively prevent GBS infection in utero or protect against late-onset infection in newborns. Not only is this approach expensive and logistically challenging, it fails to cover all, including the most severe cases in the US and Europe, and is rarely available in resource- limited settings.
The development of a GBS vaccine is also endorsed by Group B Strep Support and Group B Strep International, and GBS has been prioritized by a number of public health organizations. Both increased uptake of immunization among pregnant women and greater awareness of the implications of GBS suggest that a safe and effective vaccine targeting GBS would be well suited to address this unmet need.
PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. You can read more about them HERE