Altimmune announced that it has submitted an investigational new drug application to the FDA for a Phase 1 clinical study of its AdCOVID intranasal COVID-19 vaccine candidate, which it is developing in partnership with the University of Alabama Birmingham. The company recently announced that it had signed an agreement with Lonza for manufacturing of AdCOVID.
According to Altimmune, the FDA agreed in a pre-IND meeting that toxicology data it has reviewed as part of applications related to the company’s NasoShield intranasal anthrax vaccine and NasoVAX intranasal flu vaccine is sufficient to support the AdCOVID IND without any additional toxicology studies.
Altimmune President and CEO Vipin K. Garg said, “We’ve made exceptional progress advancing AdCOVID and are on track to begin a Phase 1 clinical study this year, with a data readout anticipated in the first quarter of 2021. While the progress being reported with current vaccines is very encouraging, many in the scientific and medical communities agree that there is continued need for next-generation vaccines that offer significant enhancements. AdCOVID has the potential to provide many benefits not offered by current vaccines, including simple intranasal administration (particularly well-suited for use in children), the ability to be transported at room temperature and conveniently stored in refrigerators for years, and the stimulation of nasal mucosal immunity with the potential to provide sterilizing immunity and block transmission of the SARS-CoV-2 virus. In addition to testing in adults, our IND included a preliminary proposal for evaluation of children as young as 2 years of age, and we look forward to further discussions around our pediatric program with the FDA in the near future.”
Read the Altimmune press release.
