Altimmune Announces FDA Clearance of Single-Dose, Needle-Free, Intranasal COVID-19 Vaccine Candidate

Altimmune, Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application for its Phase 1 clinical trial of AdCOVID, a novel, single-dose, intranasal COVID-19 vaccine candidate. Altimmune expects to commence patient enrollment in the Phase 1 clinical trial in the coming week.

“We believe deployment of intranasal vaccines like AdCOVID will be essential to a successful global response to the pandemic,” said Vipin K. Garg, President and Chief Executive Officer of Altimmune. “FDA clearance of the IND marks an important step in developing a safe and effective vaccine designed to stimulate mucosal as well as systemic immunity following intranasal administration. Developing vaccines that can effectively prevent transmission is a growing imperative to block the spread of disease and combat the emergence of new variants. We look forward to the data from this trial in the coming weeks.”

The Phase 1 clinical trial will evaluate the safety and immunogenicity of AdCOVID in up to 180 healthy adult volunteers between the ages of 18 and 55. Volunteers will receive AdCOVID at one of three dose levels administered as a nasal spray. In addition to the primary study endpoint of safety and tolerability, the immunogenicity of AdCOVID will be evaluated by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody from nasal samples, and T cell responses.

AdCOVID is a single-dose intranasal vaccine candidate for COVID-19. It is designed to stimulate a broad immune response including both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA, resident memory T cells) in the nasal cavity and respiratory tract.

In published preclinical studies conducted in collaboration with the University of Alabama at Birmingham, potent serum-neutralizing antibody responses, T cell responses, and a robust induction in mucosal immunity were observed in mice following a single intranasal dose of AdCOVID. Mucosal immunity was characterized by IgA antibody and resident memory T cell responses in the respiratory tract, both of which are believed to be important in fighting infection, and importantly, transmission.

Based on data from Altimmune’s other intranasal platform vaccine candidates, AdCOVID is expected to have extended stability at room temperature that would allow for cold chain-free shipment of the vaccine. If demonstrated, AdCOVID could be stored in the common refrigerators found in community-based doctors’ offices and pharmacies for 2 years or more. The company believes these simple and convenient handling requirements, together with the potential ability to block SARS-CoV-2 transmission, could position AdCOVID as a leading intranasal COVID-19 vaccine.

Altimmune is a clinical-stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies, and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID), anthrax (NasoShield), and influenza (NasoVAX); an intranasal immune modulating therapeutic for COVID-19 (T-COVID); and next-generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell). For more information, visit www.altimmune.com.