Janssen will commit around $604m and BARDA nearly $454m to support the ongoing Phase 3 ENSEMBLE trial programme
Janssen, the pharmaceutical business of Johnson & Johnson (J&J), has expanded its partnership with the Biomedical Advanced Research and Development Authority (BARDA) for the development of its potential Covid-19 vaccine candidate.
In February 2020, Janssen and BARDA partnered to advance the development of investigational coronavirus (Covid-19) vaccine programme.
Under the terms of the expanded partnership agreement, Janssen is expected to fund around $604m and BARDA nearly $454m to support the ongoing Phase 3 ENSEMBLE trials.
Johnson & Johnson executive committee vice chairman and chief scientific officer Paul Stoffels said: “We greatly value the ongoing confidence and support of our investigational Covid-19 vaccine candidate development program.
“Combined with our own significant investment, this agreement has enabled our vital research and development and underscores the importance of public-private partnerships to tackle the worldwide Covid-19 pandemic.”
Janssen to conduct Phase 3 ENSEMBLE and ENSEMBLE 2 trials
Phase 3 ENSEMBLE study will evaluate the single-dose regimen of Janssen’s investigational Covid-19 vaccine candidate JNJ-78436735, in up to 60,000 participants across the world.
Janssen has developed its investigational Covid-19 vaccine candidate by using its AdVac technology platform, which was also used in its EC-approved Ebola vaccine.
AdVac technology was also used to build the investigational vaccine candidates against Zika, RSV, and HIV, and to vaccinate more than 110,000 people worldwide.
Apart from the ENSEMBLE study of single-dose regimen, the company is also commencing ENSEMBLE 2 trial, which evaluates the two-dose regimen vaccine candidate.
ENSEMBLE 2 is a large-scale Phase 3 trial, designed to evaluate the safety and efficacy of a two-dose regimen of the Janssen’s potential Covid-19 vaccine in up to 30,000 participants.
The study will enrol participants in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK and the US.
Furthermore, Janssen said that positive interim results from its ongoing Phase 1/2a clinical study, evaluating safety profile and immunogenicity of both a single-dose and two-dose vaccination will follow the planned Phase 3 ENSEMBLE trials.