AstraZeneca has started a phase 1 clinical trial of its two-antibody cocktail against COVID-19. The 48-subject trial is set to deliver data later this year and set AstraZeneca up to evaluate the protective and therapeutic effect of the drug in larger phase 2 and 3 studies.
In the trial, AstraZeneca will test multiple intramuscular and intravenous doses of the drug, AZD7442, and a placebo in healthy adults. The trial is primarily designed to gather safety data. Subjects will stay at the clinical research unit for at least 24 hours after receiving AZD7442 and continue to be tracked for about one year after they are discharged.
AstraZeneca will share data from the trial well before the end of the follow-up period. As it stands, AstraZeneca expects to share data before the end of the year. The readout will inform AstraZeneca’s plans for phase 2 and 3 development of AZD7442.
AstraZeneca Ropes in Catalent Gene Therapy for Vaccine
In the hunt for a novel coronavirus vaccine, British drugmaker AstraZeneca has raced to the front of the pack with promising interim data and a slew of proposed supply deals. One of its earliest partners in the effort, New Jersey CDMO Catalent, is now adding to its responsibilities as the vaccine nears regulatory scrutiny.
AstraZeneca and Catalent have fleshed out their manufacturing deal for the University of Oxford’s adenovirus-based COVID-19 vaccine to include drug substance production, including viral vectors, at the CDMO’s gene therapy facility in Harmans, Maryland, the partners said Monday.
Catalent will start production there in the third quarter, building on its previous pact with AstraZeneca for fill-finish and packaging duties at its Anagni, Italy, site.The Harmans facility is in the vicinity of the Baltimore/Washington International Thurgood Marshall Airport—nearby air transport is common among commercial gene therapy manufacturing sites—and includes 20,000 square feet of commercial and clinical capacity. The facility is one of five gene therapy sites Catalent operates in Maryland and holds multiple CGMP manufacturing suites, including fill-finish, testing, warehousing and supply chain capabilities.