Novo Holdings REPAIR Impact Fund supports upsized MinervaX EUR 47.4M Series B financing to advance novel vaccine against Group B Streptococcus

- 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 III pivotal trials

- Novel vaccine candidate offers viable alternative to antibiotics, thereby strategically aligned with REPAIR Impact Fund's mission to combat antimicrobial resistance (AMR)

- Initial investment in MinervaX by Novo Seeds and supported by REPAIR Impact Fund through previous rounds

- Group B Streptococcus (GBS) is one of the leading causes of stillbirth and infant mortality representing a significant unmet need globally, including in the US and Europe; nearly one in five women globally are colonized by GBS

COPENHAGEN, Denmark, Dec. 15, 2020 /PRNewswire/ -- Today, the Novo Holdings REPAIR Impact Fund announces a further investment in MinervaX, a privately held Danish biotechnology company developing a novel vaccine against Group B Streptococcus (GBS), renewing its commitment to the company following two tranches of investment in 2018 and 2019.  Initial investment in MinervaX was from Novo Seeds, and has since been supported by the Novo Holdings REPAIR Impact Fund. The new investment is part of an upsized EUR 47.4 Million series B financing round additionally supported by new investors, Sanofi Ventures, Wellington Partners, Adjuvant Capital, Industrifonden and existing investor Sunstone Life Science Ventures and LF Investment. Proceeds will advance the clinical development of MinervaX's novel GBS vaccine through Phase II clinical trials, as well as manufacturing and regulatory preparation for Phase III.

GBS is responsible for nearly half of all life-threatening infections in newborns. MinervaX's protein-only GBS vaccine targets pregnant women for the prevention of adverse pregnancy outcomes and life-threatening neonatal infections associated with GBS. Globally, 15-25% of women are colonized 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 colonization may lead to late-term abortions, premature delivery or stillbirth; and in newborn children 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 infections occurring in newborns. As this approach is expensive and logistically challenging, it fails to cover all, including the most severe cases in the US and Europe, nor is it available in resource-limited settings.

Commenting on the investment, Emmanuelle Coutanceau, Partner at Novo Seeds and Board Member at MinervaX, said: "MinervaX is developing an important vaccine against a potentially fatal pathogen and, in doing so, is furthering the battle against antimicrobial resistance. This is a landmark for the Novo Holdings REPAIR Impact Fund with the first company in the fund moving to Phase II. We are also delighted to help bring together such a strong syndicate in a company where Novo was the first investor. We look forward to working with the experienced management team and this group of renowned investors to build a company that addresses an unmet medical need while helping to change the future of antimicrobial resistance."

Aleks Engel, Partner of Novo Holdings and Director at REPAIR Impact Fund, added: "MinervaX's new vaccine candidate is appealing to us not only because it has the ability to be a potentially life-saving treatment, but also because its successful development will provide a strong and proven alternative to antibiotics in an area where there is currently significant medical need. The REPAIR Impact Fund continues to passionately support ventures developing novel science to tackle the rising threat of AMR as more and more people around the world rely every day on anti-infectives."

Per Fischer, Chief Executive Officer of MinervaX, commented: "We are pleased to have received funding from such a strong investment syndicate. It is a significant endorsement of the potential of our vaccine. The REPAIR Impact Fund supports companies involved in the discovery and early-stage development of therapies targeting resistant microorganisms. It was instrumental in putting together this stellar investor syndicate, and we value the team's continued support as we progress our novel vaccine candidate through Phase II clinical trials to develop a new standard of care in preventing GBS infections."

MinervaX has completed Phase I studies across 300 healthy female subjects, generating compelling data to support advancing its novel vaccine candidate to Phase II trials. Studies to date have demonstrated a favourable safety profile, while generating high levels of long-lasting antibodies, which are capable of mobilizing the immune system against GBS bacteria and preventing invasion of epithelial and endothelial cell barriers.

More than 700,000 people die each year from infections resistant to most or all antibiotics, and the number is increasing by the day. 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, a total of USD 59 million has been invested in nine companies developing promising novel anti-infective therapies across modalities, geographies, pathogens and indications.

Enquiries

Optimum Strategic Communications
Mary Clark, Manel Mateus
+44 (0) 20 3922 1906
novo@optimumcomms.com

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 (into Phase 2). 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 A/S

Novo Holdings is recognized as a leading international life science investor, with a focus on creating long-term value. As a life science investor, Novo Holdings provides seed and venture capital to development-stage companies and takes significant ownership positions in growth and well-established companies. Novo Holdings also manages a broad portfolio of diversified financial assets. Further information: http://www.novoholdings.dk 

About MinervaX

MinervaX is a Danish biotechnology company, established in 2010 in order 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.

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.