Scandinavian Biopharma secures €10.6 million from EDCTP for a Phase III trial of ETVAX® in children in low- and middle-income countries

Scandinavian Biopharma has been awarded a €10.6 million grant from EDCTP in international competition for the planned Phase III clinical trial of the ETEC vaccine candidate ETVAX^®. The EDCTP grant is a part of the European Framework Programme for Research and Innovation, Horizon 2020.

The project will include the development and manufacturing of an all-in-one vaccine formulation that will be tailor-made for the paediatric population in low- and middle-income countries (LMIC). The main purpose of the all-in-one formulation is to make the vaccine preparation more fieldable and user-friendly. The objective is to design a vaccine formulation ready to use without adding water separately.

Furthermore, a pivotal Phase III trial in Zambia including approximately 7 500 children will be conducted. Positive results from this study will pave the way for a prequalification of the vaccine by WHO, enabling the use of ETVAX® in LMIC.

ETEC is a major cause of diarrhoeal disease in children living in ETEC endemic countries. Globally, there are nearly 1.7 billion cases of childhood diarrhoeal disease every year leading to approximately 700 000 deaths in children below five years of age. ETVAX^® could potentially save hundreds of thousands of lives every year and prevent immense physical suffering and malnutrition due to repeated bouts of illness.

“We are very proud that the World Health Organizations (WHO) considers ETVAX^® to be the lead ETEC vaccine candidate and that we have been awarded an additional grant from EDCTP to cover the remaining Phase III trial for children in LMIC. An approved ETEC vaccine would really be a game changer for public health initiatives in LMIC and this grant truly highlights the importance of our vaccine development efforts. Thanks to the support from EDCTP we can accelerate the development program for ETVAX®”, says Björn Sjöstrand, CEO of Scandinavian Biopharma.

About ETVAX®

ETVAX® is the registered trademark of Scandinavian Biopharma’s vaccine candidate against diarrhoeal disease caused by ETEC. ETVAX® is currently in Phase IIb clinical trials to evaluate safety and estimate the protective efficacy in 743 Finnish travellers to Benin. The study will be unblinded Q1 2020.

ETVAX® is the only ETEC vaccine in late phase development and is judged as the most advanced ETEC vaccine project. The strong immunogenicity and safety data 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 low-middle income countries as well as in travellers. Currently there is no ETEC vaccine available on the market for use in either children or travellers.