MinervaX provides clinical and leadership update

MinervaX provides clinical and leadership update

• 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 2 study in pregnant women, in Denmark and United Kingdom
• Vaccine Expert and Biotech Entrepreneur Gerd Zettlmeissl appointed new Chairman of the Board of Directors
• Leading vaccine industry veterans join Scientific Advisory Board

Copenhagen, Denmark, 7 October 2021 – MinervaX, a privately held Danish biotechnology company developing a novel vaccine against Group B Streptococcus (GBS), today announces clinical progress on its maternal GBS vaccine as well as multiple additions to its leadership teams.

MinervaX is developing a maternal vaccine for the prevention of adverse pregnancy outcomes and life-threating infections caused by Group B streptococcus (GBS). GBS is responsible for nearly half of all life-threatening 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.

Clinical Update:

MinervaX announces today completed enrolment of 150 pregnant women in a Phase 2 study in South Africa, sponsored by the European Developing Countries Trial Partnership. Dosing of an additional 50 pregnant women in the same study has started in Uganda. The study is listed on clinicaltrials.gov under NCT04596878.

MinervaX has also started dosing healthy adult women previously receiving the Company’s GBS vaccine in a Phase 1 booster study in the United Kingdom. The study is listed on clinicaltrials.gov under NCT05005247.

Finally, MinervaX has received regulatory approval from the Danish Medicines Agency and UK MHRA to initiate a Phase 2 study in 270 pregnant women in Denmark and the United Kingdom.

Corporate Update:

Gerd Zettlmeissl joins MinervaX as new Chairman of the Board of Directors. Gerd brings a wealth of experience from the vaccine and broader biotech industry, including several successful biotech exits.

MinervaX announces the addition of Ralf Clemens, Jean-Paul Prieels, Peter Patriarca, Jean Smal, Clement Lewin, and Inca Kusters as new members of its Scientific Advisory Board (SAB).

Commenting on the announcement, Per Fischer, Chief Executive Officer of MinervaX, said: “We are very pleased with the progress in clinical development of our maternal GBS vaccine since closing our last financing round in December 2020. The vaccine has to date demonstrated high immune responses even in individuals with low levels of preexisting immunity to GBS who are most at risk of invasive disease. The vaccine has also demonstrated a very promising safety profile in both non-pregnant and pregnant women in past and ongoing clinical studies. The progress represents a significant advancement towards initiating Phase 3 clinical studies”

“We are also very pleased to welcome Gerd Zettlmeissl as new Chairman of the Board of Directors as well as the members of the expanded Scientific Advisory Board. The additions bring valuable business and development expertise to the Company.”

Gerd Zettlmeissl, Chairman of MinervaX Board of Directors said: “I am very excited about the outstanding progress MinervaX is making in the development of one of the globally most promising GBS vaccine candidates and about the opportunity to support the company towards future success.”

Ralf Clemens, MinervaX Scientific Advisory Board member said: “Group B Streptococcus is a leading cause of neonatal sepsis and despite efforts since many years by academia and industry to develop a prophylactic vaccine progress so far is limited. The MinervaX phase 2 candidate has shown very promising immunogenicity data and an excellent safety profile, and the company has a clear plan of path to licensure. The studies in Uganda, UK and Denmark are a critical piece of that plan.”