MinervaX scaling up supply of novel GBS vaccine, ahead of phase III studies Wacker Biotech to manufacture active vaccine protein ingredients and prepare for commercial supply after regulatory approval Vaccine to address the unmet medical burden of GBS, both by maternal vaccination to prevent adverse pregnancy outcomes and life-threatening infections in infants and by vaccination…

New investment from EQT Life Sciences and OrbiMed with participation from existing investors MinervaX will hold financial reserves of more than €125 million, following the financing The financing supports the Company’s efforts to commence a Phase III clinical trial of its Maternal Vaccine against Group B Streptococcus Copenhagen, Denmark, 11 October 2023 – MinervaX ApS,…

Full enrolment and dosing commenced with its novel, prophylactic GBS vaccine in both healthy older adults and older adult population with co-morbidities First immunological read-outs are anticipated in Q4, 2023 Copenhagen, Denmark, 27 June 2023 – MinervaX ApS, a privately held Danish biotechnology company developing a novel, prophylactic vaccine against Group B Streptococcus (GBS), has…

Expands development of novel GBS vaccine in older adult population Targeting significant and growing unmet medical need of GBS infection Copenhagen, Denmark, 17 April 2023 – MinervaX ApS, a privately held Danish biotechnology company developing a novel vaccine against Group B Streptococcus (GBS), announces the first phase 1 clinical study in older adults of its…

Newly appointed CMO with more than 25 years’ experience in vaccine development Fast Track status granted by US Food and Drug Administration Completion of enrolment of its 2nd phase II clinical trial in pregnant women Copenhagen, Denmark, 5 January 2023 – MinervaX ApS, a privately held Danish biotechnology company developing a novel vaccine against Group…

Financing from new investors Trill Impact Ventures and Pureos Bioventures as well as existing investors Backing from European Investment Bank Planning for Phase 3 clinical development of novel GBS vaccine Copenhagen, Denmark, 15 December 2022 – MinervaX ApS, a privately held Danish biotechnology company developing a novel vaccine against Group B Streptococcus (GBS), today announces…

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…

Completed enrolment of all pregnant women in a Phase 2 study in South Africa and Uganda Following clearance from the US FDA, Danish Medicines Agency and UK MRHA, started enrolment of pregnant women in a Phase 2 study in Denmark and the UK Completed enrolment of a Phase 1 booster study in the UK Copenhagen,…

Completed enrolment of 150 pregnant women in a Phase 2 study in South Africa and dosing started in an additional 50 pregnant women in Uganda, as part of same study Phase 1 booster study started in the United Kingdom Regulatory approval obtained from Danish Medicines Agency and UK MHRA for the initiation of a Phase…

MinervaX raises upsized EUR 47.4M (USD 57M) Series B to advance its novel Group B Streptococcus vaccine through mid-stage clinical trials. On the back of highly promising Phase Ib data, MinervaX has raised financing from leading investors to accelerate development of its novel vaccine through the end of Phase II trials and preparations for Phase…