Novo Holdings REPAIR Impact Fund supports MinervaX EUR 72M financing to develop novel vaccine against Group B Streptococcus

• Novel vaccine candidate offers viable alternative to antibiotics, thereby strategically aligned with REPAIR Impact Fund's mission to combat antimicrobial resistance (AMR)
• Novo Holdings made the initial investment in MinervaX in 2014
• GBS is one of the leading causes of stillbirth and infant mortality globally

COPENHAGEN, Denmark, Dec. 15, 2022 /PRNewswire/ -- Novo Holdings' REPAIR Impact Fund today announces that it has participated in the EUR 72 million financing of MinervaX, a privately held Danish biotechnology company developing a novel vaccine against Group B Streptococcus (GBS). Novo Holdings first invested in Minervax in 2014 and remains its largest shareholder.

The financing will enable MinervaX to advance the late-stage development of its GBS vaccine candidate in preparation for a Phase 3 clinical trial. The vaccine candidate was recently awarded PRIME status by the European Medicines Agency (EMA) due to its potential to prevent life-threatening infections in newborn babies. MinervaX aims to expand its clinical development team and evaluate the Phase 2 clinical data for efficacy and safety ahead of publication next year.

GBS is responsible for nearly half of all life-threatening infections in newborns. MinervaX's GBS vaccine candidate targets pregnant women for the prevention of adverse pregnancy outcomes and life-threatening neonatal infections associated with GBS. Globally, 15-25% of women are colonised with GBS, and they run the risk of transmitting the bacteria to their child in utero, during birth and/or during their first months of life. GBS colonisation may lead to late-term abortions, premature delivery or stillbirth; and in newborn babies may result in sepsis, pneumonia or meningitis, all of which carry a significant risk of severe morbidity, long-term disability or death.

Emmanuelle Coutanceau, Partner at Novo Holdings and Board Member at MinervaX, said: "MinervaX is working towards a potential life-saving vaccine hence making a vital contribution to the global fight against antimicrobial resistance (AMR). As the largest investor in the Company, we are proud to see the immense progress MinervaX has achieved and are delighted to see the Company approach Phase 3 preparations in an area of huge unmet need. This is a milestone for the REPAIR Impact Fund as the first company in its portfolio to reach such an advanced development stage."

Aleks Engel, Partner at Novo Holdings and Director at REPAIR Impact Fund, added: "Over the last decade, investors and big pharma abandoned the field of antibiotic development because of the relatively low return on investment. More recently, a new wave of research targeting high-priority resistant pathogens has emerged. Our mission at the REPAIR Impact Fund is to support those ventures developing novel solutions to avoid the further emergence and spread of drug-resistant infections, a silent epidemic. As it plans for Phase 3 studies, MinervaX may soon provide an alternative to the widespread use of antibiotics, thereby being strategically aligned with our purpose of increasing humanity's therapeutic arsenal in the fight against AMR."

Per Fischer, Chief Executive Officer of MinervaX, said: "We are delighted to announce this financing, which gives us the firepower to accelerate the development of our novel GBS vaccine. GBS can be life-threatening for newborn babies and there is no approved, universally available vaccine to date.  I would like to thank the REPAIR Impact Fund and fellow investors as well as the MinervaX team who have worked very hard on our vaccine candidate in preparation for the final stage of clinical development."

More than 3,500 people die each day from infections resistant to most or all antibiotics, and the number keeps increasing. Such infections are projected to kill more people than cancer by 2050. Global economic output is expected to be reduced by between 2% and 3.5% and to severely cripple modern medical and surgical advances. For this reason, Novo Holdings created the REPAIR Impact Fund to confront this pending global medical catastrophe. Since the launch of the REPAIR Impact Fund in 2018 DKK 0.5 billion has been invested in ten companies developing promising novel anti-infective therapies across modalities, geographies, pathogens and indications.

About the REPAIR Impact Fund

The Fund invests in start-ups, early-stage companies and corporate spin-outs around the world. It gives priority to first-in-class therapies, covering small molecules, biologics and new modalities, from the early stage of drug development (lead optimization) to later stages of clinical development. It can invest as the sole investor or in a syndicate, with investments ranging from EUR 1 million to EUR 12 million.

The projects are selected through an investment process with support from a highly qualified Scientific Selection Board, comprising ten world-class experts. For more information about members of the Scientific Selection Board, see www.repair-impact-fund.com/people.

The Fund focuses on priority pathogens as defined by the World Health Organization and the United States Centers for Disease Control and Prevention, a catalogue of 18 families of bacterial and fungal pathogens that pose the greatest threat to human health. For more details about the investment process, see www.repair-impact-fund.com/investment-process.

REPAIR is an acronym: Replenishing and Enabling the Pipeline for Anti-Infective Resistance.

About Novo Holdings

Novo Holdings is a holding and investment company that is responsible for managing the assets of the Novo Nordisk Foundation, one of the world's largest enterprise foundations. The purpose of Novo Holdings is to improve people's health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.

Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk and Novozymes (the Novo Group companies) and manages an investment portfolio, with a long-term return perspective. Novo Holdings invests in life science companies of all stages of development and also manages a broad portfolio of equities, bonds, real estate and infrastructure assets as well as private equity investments.

As of year-end 2021, Novo Holdings had total assets of USD 106 billion. Further information: www.novoholdings.dk.

About MinervaX

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 immunisation, 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 colonised 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 colonisation 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 do not comprehensively prevent GBS infection in utero or protect against late-onset infection in newborns. Not only is this approach expensive and logistically challenging, but it also 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 MinervaX's novel GBS vaccine candidate is also endorsed by Group B Strep Support and Group B Strep International, and GBS has been prioritised by a number of public health organisations. Both increased uptake of immunisation 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.