Altimmune and UAB Announce Publication of Compelling Pre-clinical Data for AdCOVID™ Intranasal COVID-19 Vaccine Candidate
Comprehensive analysis shows AdCOVID uniquely stimulates three key immune components: serum neutralizing antibody, T cell responses, and mucosal immunity in the respiratory tract
Nasal mucosal immunity may be the critical factor in driving sterilizing immunity and preventing further spread of the virus by vaccinated individuals
AdCOVID is based on the Company’s adenovirus-based intranasal vaccine platform and expresses the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. The RBD is essential for viral infection and the majority of neutralizing antibodies from people that have recovered from COVID-19 bind to the RBD, highlighting the importance of the RBD in controlling infection.
AdCOVID is designed to offer significant advantages over other COVID-19 vaccine approaches, including intranasal administration, single-dose effectiveness, broad activation of the immune response, and the ability to ship and store the vaccine conveniently and inexpensively.
Altimmune anticipates filing an IND with the U.S. Food and Drug Administration and commencing a Phase 1 safety and immunogenicity trial of AdCOVID in the fourth quarter of 2020.
Key Findings of the Study:
In the BioRxiv.org publication, the authors present data demonstrating strong activation of all three arms of the adaptive immune system following a single intranasal dose of AdCOVID. These data, conducted in two strains of mice, show that AdCOVID stimulated strong immune responses including:
- Serum Neutralizing Immunity: AdCOVID elicited a median serum neutralization titer against wild-type SARS-CoV-2 virus of up to 1:563 one-month post-vaccination in a 50% focus reduction neutralization test (FRNT). For context, this level of neutralizing activity was at least 3-fold higher than the minimum titer recommended by the FDA for convalescent plasma used in the treatment of COVID-19.
- T cell Immunity: AdCOVID stimulated both CD4+ and CD8+ antigen-specific T cell responses following a single intranasal vaccination. The response was focused in the lungs of the vaccinated mice and was biased toward CD8+ T cells. A significant fraction of the CD8+ T cells in the lung were found to be non-circulating tissue-resident memory (Trm) T cells, which have been shown to play a front-line role in fighting respiratory viral infections.
- Mucosal Immunity: Nasal mucosal immunity is a local type of immunity that has the potential to stop both infection and transmission of the virus. Significantly, only an intranasal vaccine can activate this important type of immunity. AdCOVID induced a 29-fold increase in mucosal IgA specific to the RBD, well above the level associated with protection in clinical studies of mucosal influenza vaccines where a 2 to 4-fold increase in IgA was found to be correlated with protection. The observed IgA response, together with the lung-associated Trm T cell response noted above, provided an additional level of immune response that may provide enhanced protection against COVID-19 disease and transmission.
“Our collaboration with UAB has been extremely productive and the preclinical data for AdCOVID continue to show promising differentiation from other COVID-19 vaccine candidates”, said Dr.
“We are delighted that our work has provided convincing data on the potential of AdCOVID to provide broad and effective immune response, and look forward to continued collaboration with Altimmune on this important program,” said Dr.
AdCOVID is designed to offer several important advantages over other vaccine approaches, including single-dose intranasal administration, a broad immune response that includes mucosal immunity, and the ability to ship and store the vaccine conveniently and inexpensively.
Expected Attributes of AdCOVID
- Single dose protection
- Mucosal and systemic immunity to block infection and transmission
- Needle-free nasal spray, potential for self-administration
- Excellent tolerability profile
- Attractive stability profile for cold chain-free distribution
Because intranasal dosing can stimulate local mucosal immunity, AdCOVID is expected to guard the respiratory tract from viral invasion and provide downstream protection against viral spread. Local mucosal immunity may be essential for creating sterilizing immunity that eliminates the last traces of viral infection in the nasal cavity. Recent studies have shown that in the absence of mucosal immunity, the nasal cavity may become a reservoir for the coronavirus, potentially prolonging infection while allowing for disease transmission. Importantly, nasal mucosal immunity can only be achieved by administering a vaccine intranasally.
AdCOVID also provides an easier route of administration than an injection which may eliminate the need for administration by trained medical personnel and may even allow for self-administration. Finally, based on data from Altimmune’s other platform vaccines (NasoVAX™ and NasoShield™) AdCOVID is expected to have extended stability at room temperature allowing for cold chain-free distribution of the vaccine where it can then be stored in the common refrigerators found in community-based doctor’s offices and pharmacies for two years or more. The simple and convenient handling requirements may greatly increase the number of people willing to take the 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 on Altimmune, please visit www.altimmune.com.
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, submitting an IND with the U.S. Food and Drug Administration and commencing a Phase 1 safety and immunogenicity trial of AdCOVID in the fourth quarter of 2020, the potential immunization effects of AdCOVID, our ability to manufacture AdCOVID beginning this year, and the prospects for regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to
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Source: Altimmune, Inc.