Pressmeddelande - 11 September 2020 09:23

Scandinavian Biopharma has successfully completed the enrolment of the clinical Phase 1 trial in Zambia

We are proud to announce that, despite all challenges associated with the Covid-19 pandemic, all participants have now received the third and final vaccination dose in our Phase 1 trial in Zambia. The study started in 2019 and is part of the late phase development program in Africa for Scandinavian Biopharma’s vaccine candidate, ETVAX®, against Enterotoxigenic Escherichia coli (ETEC). The study is funded by the EU Research and Innovation Framework Program, Horizon 2020, through the European and Developing Countries Clinical Trials Partnership (EDCTP) organization.

The study included 246 participants and the objectives were to further establish the exact safe dose and tolerability of ETVAX® in young children, as well as to explore the potential benefits of a third booster dose. The study was conducted in 40 healthy adults (18-45 years of age), followed by 60 children 10-23 months of age and lastly 146 children 6-9 months of age.

The adult participants received ETVAX® with 10ug dmLT or placebo in a double blinded manner. All children (6-23 months of age) received two doses of placebo or 1/8 or 1/4 of the adult dose of ETVAX® together with 2,5ug of dmLT. The initial two doses were then followed by a booster dose in all children.

By now, all participants have been enrolled and the last follow-up visit will be held in September. Preliminary findings suggest promising immunogenicity results and confirm the favourable safety profile of ETVAX®. All samples from the clinical study are being analysed and the results will be presented during H1 of 2021.

A large Phase 2b trial in The Gambia including children 6-18 months of age is ready to start when the Covid-19 pandemic allows. The selected dose in the Phase 2b trial is based on the favourable safety and immunogenicity data from the study in Zambia and all other previously conducted studies of ETVAX®. The outcome of the paediatric trial in Zambia as well as in The Gambia will pave the way for the pivotal Phase 3 trial which will lead up to licensure of ETVAX® and pre-qualification by World Health Organization (WHO).

Björn Sjöstrand, CEO at Scandinavian Biopharma, says: “The completion of the enrolment in the Zambian study is another important milestone towards making a vaccine available for children in low- and middle-income countries. An ETEC-vaccine is prioritized by WHO and has the potential to save hundred thousands of lives and reduce morbidity leading to poor physical and cognitive development among infants. Furthermore, the vaccine has the potential to prevent the loss of millions of well-deserved holiday trips and negative long-term gastrointestinal syndromes due to travellers diarrhoea.”

Ämnen

Kategorier

Scandinavian Biopharma

We are a research-based specialty biopharma company determined to give people worldwide a longer and better life. We are, together with researchers at the University of Gothenburg and the international non-profit organization PATH, developing 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. Currently, there is no ETEC vaccine available on the market and ETVAX® is the only ETEC vaccine candidate in late-stage development.

We also distribute a wide range of specialty biopharma products with focus on vaccines and immunoglobulins.

www.scandinavianbiopharma.se

Kontakter

Björn Sjöstrand

Presskontakt VD bjorn@scandinavianbiopharma.se +46 (0)72 712 51 20

Relaterat innehåll

Principal investigator Professor Anu Kantele visiting Benin

26 Maj 2020 09:59

Promising preliminary findings from a Phase 2b study of the oral vaccine ETVAX® against travelers’ diarrhea in Finnish travelers to Benin, West Africa

Encouraging results from a Phase 2b study. The trial enrolled adult volunteers from Finland who travelled to Benin after receiving ETVAX® or placebo. The study results confirm the excellent safety and overall positive immunogenicity of ETVAX®, as well as a significant protective efficacy of 56% against all severe diarrhea, independent of pathogen.

Scandinavian Biopharma has been awarded a €10.6 million grant from EDCTP

20 Februari 2020 08:00

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 for a Phase III clinical trial of the ETEC vaccine candidate ETVAX®. 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 LMIC. The main purpose is to make the vaccine preparation more fieldable and user-friendly.

The successful results of the Phase I/II study in Dhaka, Bangladesh, are now published in The Lancet Infectious Diseases.

20 November 2019 08:06

Scandinavian Biopharma reports successful results of the ETEC vaccine candidate ETVAX® in a placebo-controlled phase I/II study in infants and children in Bangladesh

Scandinavian Biopharma reports successful results of the oral, inactivated ETEC vaccine candidate ETVAX® against enterotoxigenic E. coli diarrhoea in a placebo-controlled phase I/II study in infants and children from 6 months to 5 years of age in Bangladesh.

From left to right: Study co-ordinator Bupe Sichalwe and site co-principal investigator Dr Nsofwa Sukwa

7 Oktober 2019 11:25

We have successfully completed the enrolment of the first cohort including 40 adults in our study in Zambia

We are proud to announce that the first cohort of 40 adults was enrolled in our Phase I study in Zambia. The study is part of a late phase development program in Africa funded by EDCTP with 7,4 million Euro. The program consists of two clinical trials and is initiated with a Phase I trial in Zambia to evaluate the optimal dose of ETVAX® and the benefits of a booster dose in young children.

11 September 2020 09:17

Scandinavian Biopharma har framgångsrikt slutfört vaccinationerna av alla deltagare i Fas 1-studien i Zambia

Vi kan idag stolt meddela att samtliga 246 deltagare i vår kliniska Fas 1-studie i Zambia nu vaccinerats med den tredje och sista vaccinationsdosen. I och med att vi avslutar studien i Zambia tar vi ännu ett viktigt kliv mot vårt mål att ta fram ett ETEC-vaccin för barn i låg- och medelinkomstländer. Ett ETEC-vaccin är prioriterat av WHO.

25 Januari 2022 08:07

Scandinavian Biopharma’s expansion requires expanded premises

We are expanding the business so much that we need larger premises. During the pandemic, the company has hired many new employees in research, clinical development, registration, manufacturing and sales. The space is specially adapted for Scandinavian Biopharma's operations and has a tailor-made, state of the art laboratory with a process development unit as well as a modern meeting place.

28 September 2021 16:13

New ETVAX® data will be presented during VASE, a conference designed to spark innovation and accelerate the momentum for research and development on enteric vaccines

The Vaccines Against Shigella and ETEC (VASE) Conference, on September 28 & 30, will provide key updates on vaccines being developed for Shigella, ETEC, and other emerging diarrheal pathogens. 2 of the 18 presentations at VASE is highlighting our ETEC vaccine candidate ETVAX®.

9 Oktober 2020 10:55

Scandinavian Biopharma enters into Agreement with USAMRAA to facilitate the development of the oral vaccine ETVAX® against travellers’ diarrhoea

Scandinavian Biopharma (SBH) has entered into an Agreement with the United States Army Medical Research Acquisition Activity (USAMRAA) to support the production and development of the ETEC-vaccine, with the long-term goal of preventing bacterial diarrhoea in war fighters.

1 Mars 2021 08:00

The first children have been vaccinated in Scandinavian Biopharma's large Phase IIb study in The Gambia

The first child has been vaccinated in The Gambia with the company's ETEC vaccine candidate, ETVAX®. It is a randomised, placebo-controlled, and double-blind phase IIb study. The study will include about 5,000 children aged 6-23 months. The overall goal of the study is to investigate the protective effect against moderate to severe diarrhoea caused by ETEC over a 1- to 2-year period.

19 November 2021 12:28

An improved formulation of Scandinavian Bioharmas ETEC vaccine candidate is currently being tested in an immunogenicity bridging study

An improved user-friendly formulation of the world's most advanced ETEC vaccine candidate, ETVAX®, has been developed to meet commercial requirements. We want to ensure that the new formulation gives rise to immune responses that are non-inferior (i.e. not worse) to the previous formulation of the vaccine that underwent earlier testing. This is done in a phase II double-blinded, randomized study.

Revenue, Distribution Business 2011-2020

23 April 2021 09:57

Scandinavian Biopharma shows strong financial results for the pandemic year 2020

The year we have left behind us has been different in many ways. Despite the major impact the pandemic had on operations in 2020, Scandinavian Biopharma reports largely unchanged revenue for the distribution operations and important progress has been made in the development of the ETEC vaccine candidate ETVAX®.