The National Institutes of Health (NIH), the US’s medical research agency, selected Exothera S.A., a full-service Contract Development and Manufacturing Organization (CDMO) specialized 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 Organization (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.

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.

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 specialized in viral vector-based vaccines”.

Peter Wright, MD, infectious disease, and international health physician at DHMC and Professor of Paediatrics at Geisel. “We are pleased to join this collaborative effort to develop and assess the safety, immunogenicity, and effectiveness of an adenovirus type 4-based vaccine expressing the SARS-CoV-2 spike protein as a novel approach to the prevention of COVID-19. Although unique in the COVID field, the vaccine has precedent in the highly successful prevention of adenovirus respiratory disease in the United States military.”

This content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Dartmouth Health

Dartmouth Health, New Hampshire’s only academic health system and the state’s largest private employer, serves patients across northern New England. Dartmouth Health provides access to more than 2,000 providers in almost every area of medicine, delivering care at its flagship hospital, Dartmouth Hitchcock Medical Center (DHMC) in Lebanon, NH, as well as across its wide network of hospitals, clinics, and care facilities. DHMC is consistently named the #1 hospital in New Hampshire by U.S. News & World Report and is recognized for high performance in numerous clinical specialties and procedures. Dartmouth Health includes Dartmouth Cancer Center, one of only 53 National Cancer Institute-designated Comprehensive Cancer Centers in the nation, and the only such center in northern New England; Dartmouth Health Children’s, which includes the state’s only children’s hospital and multiple locations around the region; member hospitals in Lebanon, Keene and New London, NH, and Windsor and Bennington, VT; Visiting Nurse and Hospice for Vermont and New Hampshire; and more than 24 clinics that provide ambulatory and specialty services across New Hampshire and Vermont. Through its historical partnership with Dartmouth and the Geisel School of Medicine, Dartmouth Health trains nearly 400 medical residents and fellows annually, and performs cutting-edge research and clinical trials recognized across the globe with Geisel and the White River Junction VA Medical Center in White River Junction, VT. Dartmouth Health and its more than 13,000 employees are deeply committed to serving the healthcare needs of everyone in our communities, and to providing each of our patients with exceptional, personal care.

About Dartmouth’s Geisel School of Medicine

Founded in 1797, the Geisel School of Medicine at Dartmouth strives to improve the lives of the communities it serves through excellence in learning, discovery, and healing. The Geisel School of Medicine is renowned for its leadership in medical education, healthcare policy and delivery science, biomedical research, global health, and in creating innovations that improve lives worldwide. As one of America’s leading medical schools, Dartmouth’s Geisel School of Medicine is committed to training new generations of diverse leaders who will help solve our most vexing challenges in healthcare.

Website: https://geiselmed.dartmouth.edu/

About Exothera SA

Exothera is contract development, and manufacturing organization (CDMO) dedicated to viral vector and nucleic acids production. As a technology-driven company, Exothera provides best-in-class bioprocessing expertise that capitalizes on the best and most innovative manufacturing technologies developed within the Univercells group. The company delivers process development/optimization to rapidly reach GMP clinical and commercial production of vaccines, viral vectors, and nucleic acids. At Exothera and Univercells, our mission is to make life-changing therapies available to all.

Website: www.exothera.world