Altimmune Inc. (ALT:NASDAQ), which is focused on developing treatments for liver disease, intranasal vaccines and immune modulating therapies, yesterday announced that it pre-published a "comprehensive preclinical evaluation of its single-dose, intranasal COVID-19 vaccine candidate, AdCOVID™, in a manuscript entitled, Single-dose intranasal administration of AdCOVID elicits systemic and mucosal immunity against SARS-CoV-2 in mice."
The firm advised that the ongoing studies expand upon earlier preclinical data presented for the AdCOVID program and were jointly conducted with the University of Alabama at Birmingham (UAB). The company noted that the full manuscript is now available for viewing.
The company explained that "AdCOVID is based on its adenovirus-based intranasal vaccine platform and expresses the receptor binding domain of the SARS-CoV-2 spike protein." The company noted that the AdCOVID design approach provides many important advantages compared to other COVID-19 vaccine approaches as it offers a single-dose, intranasal administration that activates a broad immune response.
Altimmune stated that it expects to file an Investigational New Drug Application with the U.S. Food and Drug Administration and plans to start a Phase 1 safety and immunogenicity trial of AdCOVID in Q4/20.
The company highlighted the key findings from the publication and stated that "the authors of the study presented data demonstrating strong activation of all three arms of the adaptive immune system following a single intranasal dose of AdCOVID." Specifically, the data obtained from two separate strains of mice showed that AdCOVID stimulated strong immune responses including Serum Neutralizing Immunity, T cell Immunity and Mucosal Immunity.
Altimmune's Chief Scientific Officer Dr. Scot Roberts, Ph.D., commented, "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...Intranasal vaccination represents an attractive strategy to prevent COVID-19 infection, as the nasal cavity comprises the first line of defense against the SARS-CoV-2 virus prior to entry into the lungs. By stimulating mucosal antibody and T cell immunity, along with potent systemic neutralizing antibody titers, all three arms of the immune system can work in concert to prevent and control infection."
"Current first-generation COVID-19 vaccines, which are given by intramuscular injection, are unable to activate nasal mucosal immunity, which may not only be critical for mounting a comprehensive immune response, but may also prevent further spread of the virus by blocking transmission," Dr. Roberts added.
Dr. Frances Lund, Ph.D., Charles H. McCauley Professor and Chair of the UAB Department of Microbiology and principal investigator and co-author of the manuscript, remarked, "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."
The company claimed that AdCOVID offers a much easier route of administration compared to injections, and may possibly allow for self-administration without the need for administration by trained medical staff. The firm noted that compared to other alternatives being developed in the marketplace, similar to Altimmune's other platform vaccines (NasoVAX™ and NasoShield™), it is anticipated that when AdCOVID is deployed, it will have extended stability at room temperature. The firm explained that this will "allow 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 company stated that it is hopeful that the ease of administration and simple, convenient handling requirements will greatly aid in increasing the number of people willing to take the vaccine.
Altimmune is a clinical stage biopharmaceutical company headquartered in Gaithersburg, Md., that is engaged in the development of treatments for liver disease, immune modulating therapies and intranasal vaccines. The firm noted that its "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™)."
Altimmune has a market capitalization of around $414.7 million with approximately 32.9 million shares outstanding and a short interest of about 6.3%. ALT shares opened almost 13% higher today at $14.20 (+$1.60, +12.70%) over yesterday's $12.60 closing price. The stock has traded today between $13.83 and $16.25 per share and is presently trading at $14.10 (+$1.50, +11.90%).[NLINSERT]
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