2:02 Labiotech.eu news
To recognize International Group B Strep Awareness Month in July, we had a conversation with MinervaX CEO, Per Fischer.
MinervaX is a privately-held Danish biotechnology company developing a novel prophylactic vaccine against Group B streptococcus (GBS), with two phase II clinical trials ongoing in pregnant women and a phase I clinical trial ongoing in older adults.
Due to the global burden and no current mechanism for preventing this invasive GBS disease available. There is an urgent need for a vaccine to prevent GBS which has a well-recognized morbidity and mortality rate.
MinervaX’s GBS vaccine has been granted Fast Track regulatory status by the US Food and Drug Administration. The process is designed to facilitate the development of investigational treatments that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions.
This follows the European Medicines Agency’s decision to award Priority Medicine (PRIME) status to the vaccine.