J&J to start P3 COVID-19 vaccine trials in September
During Johnson & Johnson’s second quarter results, the company provided an update on the progress of its lead candidate for COVID-19, Ad26.COV2-S, recombinant.
Paulus Stoffels, chief scientific officer of J&J, told investors during a call that, due to the Phase I/IIa trial beginning sooner than expected in late July, Phase III trials could be moved forward to as early as the end of September.
Further details were not revealed, however, the company stated that it will use epidemiology data to plan the location of where the study would take place.
Currently, the company is planning for its Phase II trial to take place in the Netherlands, Spain, and Germany. The trial will also start in Belgium on July 22, and then be extended into the US next week.
In terms of manufacturing, J&J has already sealed partnership deals with Catalent and Emergent to provide large-scale commercial manufacturing of the lead candidate. Originally, the aim had been to produce 1 billion dose per year, but Stoffels added that the plan is to deliver more that figure by the end of 2021.
Financials
In its Q2 results, J&J was able to point to a reported 2.1% growth in pharmaceutical sales compared to the previous year.
The growth was driven, in part, by sales of two biologic treatments, Stelara (ustekinumab) and Darzalex (daratumumab).
Christopher delOrefice, VP of investors relations, qualified that the company’s result had been affected by the COVID-19 outbreak.
He outlined, “Results were negatively impacted by the COVID-19 pandemic. However, we did see improvement throughout the quarter as countries and states began to reopen.”
The quarter was also marked by the receipt of European approval for its Ebola vaccine, Zabdeno (Ad26.ZEBOV). The technology used to develop this vaccine is the same as was used to develop its lead candidate for the novel coronavirus.