Altimmune Inc. (NASDAQ:ALT) has submitted an Investigational New Drug (IND) application to the FDA for the commencement of Phase 1 clinical study of AdCOVID, its investigational single-dose intranasal COVID-19 vaccine.
AdCOVID offers mucosal and systemic immunity
The company has designed AdCOVID to stimulate a wide range of immune responses including local immunity in the respiratory tract and nasal cavity as well as systemic immunity. Vipin Garg, the company’s CEO said that Altimmune has made considerable progress in advancing AdCOVID. As a result, the company is on track to commence a Phase 1 study of the vaccine candidate this year and data readout will be available in Q1 2021. Garg said that although there has been significant progress in the development of COVID-19 vaccines, there is still a need for next-generation vaccines offering more enhancements.
According to Garg, the AdCOVID vaccine has the potential of offering significant benefits that current vaccines don’t offer. For instance, one can administer it through the intranasal cavity making it ideal for children and can stimulate nasal mucosal immunity. This potentially offers to sterilize immunity and blocks the SARS-CoV-2 virus transmission. Most importantly the vaccine is easy to transport at room temperature and can be stored in refrigerators for many years.
Besides testing the vaccine candidate in adults, the IND includes a preliminary evaluation proposal in children from two years of age. Garg stated that they are looking forward to more discussions with the FDA regarding the pediatric program soon.
Mucosal immunity can prevent the spread of SARS-CoV-2
Charles H. McCauley Professors, Frances Lund said that it is not clear whether mucosal immunity is important in preventing SARS-CoV-2 spread by stopping transmission and replication at the infection site. He said that according to studies, the absence of mucosal immunity can lead to the nasal cavity becoming a reservoir for COVID, especially in children. As a result, this allows transmission of SARS-CoV-2 even after one has received intramuscular vaccination.
In a pre-IND meeting, the FDA agreed to the study design in Phase 1 AdCOVID study and confirmed that additional nonclinical studies were not necessary.