24 September 2020
Johnson & Johnson (J&J) has initiated the pivotal Phase III ENSEMBLE clinical trial of its Covid-19 vaccine candidate, JNJ-78436735 (Ad26.COV2.S). This large-scale, multi-country trial comes after positive interim data from a Phase I/IIa study, which showed encouraging safety profile and immunogenicity with a single vaccination. Based on these study data and discussions with the US Food and Drug Administration (FDA), ENSEMBLE is designed to recruit up to 60,000 participants across three continents.
Researchers in London are set to test vaccine candidates in the first-ever Covid-19 human challenge trials, where healthy participants will be deliberately infected with the coronavirus, according to the Financial Times. The studies are expected to commence in January at a secure quarantine facility in London. The project will be led by Imperial College London and run by Queen Mary University of London spinout hVivo.
Humanigen has partnered with Thermo Fisher Scientific to boost the manufacturing of its Covid-19 drug candidate lenzilumab, which is undergoing a Phase III registration trial. The multi-year alliance compliments Humanigen’s recent collaborations with Lonza and Catalent for large-scale commercial production of the drug candidate.
India-based Bharat Biotech has signed a licensing agreement with Washington University School of Medicine in St. Louis to develop a single-dose intranasal Covid-19 vaccine candidate. The deal provides Bharat Biotech with the rights to distribute the vaccine in all markets, excluding the US, Japan and Europe. Phase I trials of the vaccine will occur at the university, and after regulatory approval Bharat Biotech will conduct further studies and begin large scale manufacturing.
Swiss-based Relief Therapeutics has announced that its partner NeuroRx submitted a request seeking emergency use authorisation (EUA) from the US FDA for RLF-100 (aviptadil) to treat critically ill Covid-19 patients who are receiving intensive care and have exhausted all approved treatments. The submission is backed by a case-control study that compared patients treated with RLF-100 to those on maximal standard of care treatment in the same ICU by the same medical staff.