NIH and Exothera Produce GMP Intranasal Vaccine Against SARS-CoV-2 for Clinical Phase I/II Trial in Africa and US

The National Institutes of Health (NIH), the US’s medical research agency, selected Exothera S.A., a full-service CDMO specialised in gene therapy, vaccines, oncolytic viruses, and nucleic acid-based therapeutics, to develop the manufacturing process for NIH’s intranasal vaccine against SARS-CoV-2. As part of the Cooperative Research and Development Agreement, CRADA, they will be joined by researchers from Dartmouth Health’s Dartmouth Hitchcock Medical Center (DHMC) and Dartmouth’s Geisel School of Medicine with special expertise in mucosal immunity and the design and conduct of early phase clinical trials.

Live, replicating, intranasal vaccines have the promise of effectively interrupting transmission of coronavirus, COVID-19 by inducing the development of immunity in the respiratory tract. Further, intranasal vaccines are a potentially valuable alternative to injected vaccines as no specific medical training is required to perform the vaccination, similar to the oral drops given globally to prevent polio.

The World Health Organisation (WHO) lifted the Public Health Emergency of International Concern for COVID-19 on May 5, 2023, but adequate levels of vaccination of the global population remain crucial to reduce morbidity, mortality, and the risk of emerging new virus variants.

Intranasal vaccines are also an impactful tool for the distribution of a vaccine against SARS-CoV-2 in remote areas with the potential to slow transmission of COVID-19 in these regions. In the past, intranasal vaccines have been used to fight several mucosa-entering pathogens (e.g., respiratory viruses, measles, rubella).

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 will generate cGMP material using NIH's current manufacturing and analytical processes for use in US and African Phase I/II clinical trials.

Hanna Lesch, Chief Technology Officer at Exothera commented "We are proud NIH selected us for this project. Exothera has had significant expertise with adenovirus viral vectors and COVID nasal vaccines in the last three years, thanks to successful collaborations with partners and clients specialised in viral vector-based vaccines".

The project includes tech transfer, stability study, CMC study and AS development and QC testing, before initiating manufacturing of the drug product in its GMP facility in Jumet, Belgium - one of the biggest dedicated viral vectors plants in Europe that can accommodate projects from development to commercial manufacturing scale.