Scandinavian Biopharma enters into Agreement with USAMRAA to facilitate the development of the oral vaccine ETVAX® against travellers’ diarrhoea
25th of September 2020, Scandinavian Biopharma (SBH) entered into an Agreement with the United States Army Medical Research Acquisition Activity (USAMRAA) to support the production and development of the vaccine, with the long-term goal of preventing bacterial diarrhoea in war fighters.
In April this year, SBH announced the promising preliminary findings from a Phase 2b study of the oral vaccine ETVAX® against travellers’ diarrhoea in Finnish travellers to Benin, West Africa.
The preliminary results confirmed the excellent safety and overall positive immunogenicity of ETVAX®. While not reaching our protective efficacy goal of 70%, we are pleased to see a significant protective efficacy (PE = 56%) against all severe diarrhoea, regardless of pathogen, most likely because ETEC was found in 75% of all severe diarrhoea cases. The broad significant protective efficacy (52%) seen against all ETEC and bacterial co-pathogens and parasites despite the very high overall presence of bacterial enteropathogens is a strong indication that the point-estimate in a cohort with less co-pathogens could be considerably higher.
“We are proud to announce the FAR based agreement with USAMRAA. It is a great recognition of our achievements and validation of the remaining plans with the aim to license our vaccine ETVAX® against ETEC caused diarrhoea” said Björn Sjöstrand CEO at Scandinavian Biopharma.
Scandinavian Biopharma is developing, together with researchers at the University of Gothenburg and the international non-profit organization PATH, a new oral ETEC vaccine for use in both travellers and infants and young children in LMICs who continue to be at high risk for infection and severe illness from this bacterial enteric pathogen. The programs are mainly funded by the European Union’s (EU) Research and Innovation Framework Program, Horizon 2020 through the EDCTP organization, DFID, and SME Instruments supporting innovative SMEs in the health care biotechnology sector.
ETVAX® is the only ETEC vaccine candidate in late-stage development. The strong immunogenicity and safety data, as well as the early field efficacy seen in Benin clearly distinguish ETVAX® from other vaccine candidates that are under development against ETEC-induced diarrhoea. Successful development of this vaccine will address an unmet medical need of children in LMICs as well as in travellers. Currently, there is no ETEC vaccine available on the market for use in either children or travellers.
About Scandinavian Biopharma
We are a research-based specialty biopharma company determined to give people worldwide a longer and better life. We are developing the first vaccine for protection against diarrhoea caused by ETEC in both travellers and endemic populations. We distribute a wide range of specialty biopharma products with focus on vaccines and immunoglobulins.
The United States Army Medical Research Acquisition Activity (USAMRAA) is the Department of Defense’s (DoD) contracting and assistance agreement element of the United States Army Medical Research and Development Command (USAMRDC) and provides support to the Command headquarters and its worldwide network of laboratories and medical logistics organizations as well as other non-USAMRDC customers.