Pipeline
We are running two parallel ETEC development projects. The paediatric presentation is tailor-made for children below five years of age in Low- and Middle-Income Countries. The other presentation targets travellers and military personnel. Both presentations contain two components – a carbonate buffer and a vaccine component – that are mixed into water to prepare the final oral vaccine suspension.
In total, Scandinavian Biopharma has conducted six clinical trials in the US, Bangladesh, Benin, Gambia, Zambia and Sweden, all of which generated very promising results. The vaccine candidate has the potential to be the first vaccine to protect against diarrhoea caused by ETEC.
Our vaccine portfolio also includes an innovative preclinical technology for the development of a new Campylobacter jejuni vaccine.
The importance of an ETEC vaccine
An ETEC vaccine would have a significant impact on global health.
Positive results from our on-going and finished studies are accelerating the development of our tailor-made vaccine presentation for infants in low-to middle income countries where our vaccine candidate potentially could save hundreds of thousands of lives per year and prevent immense physical suffering and malnutrition due to repeated bouts of illness. The recurring episodes of diarrhoea are known to have a detrimental effect on poverty in ETEC-endemic countries.
Our vaccine candidate will also prevent long-term gastrointestinal syndromes due to diarrhoeal infections following travel, saving millions of well-deserved holiday trips and reducing the disease burden of military and health workers deployed in ETEC-endemic areas.
New vaccines are critical to combat antimicrobial resistance, believed to be one of the biggest global health threats in the future.
Vaccine composition
The vaccine candidate is a multivalent oral vaccine that contains 4 different inactivated strains expressing the most prevalent ETEC colonization factors (CFs), i.e. CFA/I, CS3, CS5 and CS6 plus the hybrid protein LCTBA and a mucosal adjuvant, i.e. a double mutant of LT (dmLT).
The vaccine composition offers two potential lines of defense. It prevents adhesion and colonization of ETEC bacteria in the intestine and it induces antibodies that neutralize the heat-labile toxin (LT) produced by the bacteria.
We are on the right path
Our ETEC-vaccine candidate has demonstrated an excellent safety profile and exceeded expectations for immunogenicity in the completed and on-going studies.
Another proof that we are on the right path and that our vaccine is of very high standard is that we are supported by PATH, an important product development partner of Bill and Melinda Gates Foundation, and the EU Research and Innovation programme, Horizon2020.
In June 2020 during WHO’s Product Development for Vaccines Advisory Committee meeting, our vaccine candidate was rated by independent scientists as the most advanced ETEC vaccine candidate in the world.
