The National Institutes of Health (NIH) has selected Belgium CDMO Exothera to develop the manufacturing process for the agency's intranasal vaccine against SARS-CoV-2.
NIH’s candidate is based on the adenovirus 4 backbone, largely used as a vector candidate in HIV and influenza vaccine clinical trials, produced in an A549 cell line.
Exothera, who specializes in GMP clinical and commercial production of viral vectors and nucleic acids, will generate CGMP material using NIH’s current manufacturing and analytical processes for use in U.S. and African phase I/II clinical trials. As part of the Cooperative Research and Development Agreement (CRADA), they will be joined by researchers from Dartmouth Health’s Dartmouth Hitchcock Medical Center and Dartmouth’s Geisel School of Medicine.
The project includes tech transfer, stability studies, CMC studies and analytical development and QC testing, before initiating manufacturing of the drug product in Exothera's GMP facility in Jumet, Belgium — one of the largest dedicated viral vectors plants in Europe that can accommodate projects from development to commercial manufacturing scale.
Intranasal vaccines are seen as a potentially valuable alternative to injected vaccines as no specific medical training is required for vaccination. Maryland-based Altimmune had an intranasal vaccine for COVID in the clinic, but abandoned it in 2021 following a failed phase 1 trial. Last year, New York-based Codagenix initiated dosing in a phase 3 efficacy trial of its intranasal COVID vaccine as part of a WHO-sponsored trial.
