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Altimmune COVID-19 Vaccine Candidate Tested at UAB Shows Positive Preclinical Results

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Altimmune, Inc., a clinical-stage biopharmaceutical company, has announced positive results from the preclinical studies conducted in mice at the University of Alabama at Birmingham of its intranasal COVID-19 vaccine candidate, AdCOVID.

The studies — a collaboration between UAB and the Gaithersburg, Maryland-based Altimmune — showed strong serum neutralizing activity and potent mucosal IgA immunity in the respiratory tract. The induction of IgA antibody in the respiratory tract may be necessary to block both infection and transmission of the virus to prevent further spread of COVID-19. Based on these findings, AdCOVID is expected to be advanced to a Phase 1 safety and immunogenicity study in Q4 of this year.Frances Lund, Ph.D.

Credit: UAB

AdCOVID is designed to express the receptor binding domain of the SARS-CoV-2 virus spike protein, a key immune target that is essential for the virus to bind to cells and initiate infection. By focusing the immune response to this portion of the viral spike protein, AdCOVID elicited a strong systemic antibody response against the receptor binding domain in mice, achieving serum IgG antibody concentrations greater than 800 micrograms per milliliter just 14 days after administration of a single intranasal dose. In addition, AdCOVID stimulated serum viral neutralization titers of 1:320 by Day 28, two-times higher than the titer recommended by the U.S. Food and Drug Administration for investigational convalescent plasma as a treatment for severe COVID-19.

In a separate study with UAB, a single intranasal dose of AdCOVID stimulated a 29-fold induction of mucosal IgA in bronchoalveolar fluid of vaccinated mice. This level of IgA antibody stimulation is well above that associated with protection from disease in clinical studies of other mucosal vaccines. Frances Lund, Ph.D., lead UAB investigator for preclinical testing of the AdCOVID vaccine candidates, said, “The potent stimulation of mucosal IgA immunity in the respiratory tract may be crucial to effectively block infection and transmission of the SARS-CoV-2 virus, given that the nasal cavity is a key point of entry and replication for the SARS-CoV-2 virus.”

“Stimulation of immunity at this level just 14 days after a single dose is impressive for any vaccine, and is particularly notable for a potential coronavirus vaccine,” said Lund, the Charles H. McCauley Professor and chair of the UAB Department of Microbiology. The Lund lab did the preclinical testing in collaboration with the labs of Troy Randall, Ph.D., professor of medicine in the UAB Division of Clinical Immunology and Rheumatology; Kevin Harrod, Ph.D., professor in the UAB Department of Anesthesiology and Perioperative Medicine; and three more UAB Department of Microbiology labs led by Rodney King, Ph.D., assistant professor, Todd Green, Ph.D., associate professor, and John Kearney, Ph.D., professor.

In other details from the collaborative preclinical work, Altimmune announced that the antibody responses were accompanied by a rapid recruitment of CD8+ T cells, CD4+ T cells, dendritic cells and natural killer cells in the respiratory tract. Increases in both germinal center and memory B cells, as well as T follicular helper cells, all associated in prior vaccine development research with the generation of long-lived antibody responses, were observed in regional lymph nodes and the spleen.

Preclinical data for the antigen-specific T cell response are expected in coming weeks, along with additional immunogenicity readouts.

The Altimmune-UAB collaboration was announced March 30, and Lund made that work the highest priority for her group. “The goal,” she said in March, “is to get the data to Altimmune as rapidly as possible, so they will use the information gained from the preclinical study to design their clinical trial in people.”

Intranasal dosing provides AdCOVID with the potential to be administered rapidly and without the need for needles, syringes or trained healthcare personnel. In addition, AdCOVID’s expected room temperature stability profile may allow for broad distribution of the vaccine without the need for expensive cold-chain logistics, such as refrigeration or freezing.

UAB has extensive experience in conducting clinical studies of vaccines and has participated in studies sponsored by the Vaccine Evaluation and Trial Unit, part of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

At UAB, Randall holds the William J. Koopman Endowed Professorship in Rheumatology and Immunology, Harrod holds the Benjamin Monroe Carraway, M.D., Endowed Chair in Anesthesiology, and Kearney holds the Endowed Professorship in Immunology.

Contacts and sources:

Jeff HansenUniversity of Alabama at Birmingham

 



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Total 3 comments
  • Fake News = The False Prophet

    Altimmune is a clinical stage biopharmaceutical company focused on developing treatments for liver disease and immune modulating therapies. Our diverse pipeline includes next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™), conjugated immunostimulants for the treatment of cancer (ALT-702) and intranasal vaccines (NasoVAX™ and NasoShield™).

    July 13, 2020
    Altimmune and the University of Alabama at Birmingham (UAB) Announce Positive Preclinical Results for Intranasal COVID-19 Vaccine Candidate, AdCOVID™

    July 13, 2020
    Altimmune Announces Pricing of a Public Offering of $115 Million of Common Stock and Pre-Funded Warrants

    July 13, 2020
    Altimmune Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants

    Altimmune expects to receive gross proceeds of $115.0 million, before deducting underwriting discounts and offering expenses (without giving effect to any exercise of the underwriters’ option to purchase additional shares, if any). Altimmune anticipates using the net proceeds from the offering for general corporate purposes, which may include, but are not limited to, scale up of manufacturing and advanced clinical trials of AdCOVID, a single dose intranasal COVID-19 vaccine candidate; the continued development of ALT-801, its dual GLP-1/glucagon receptor agonist for the treatment of non-alcoholic steatohepatitis (NASH), including manufacturing and clinical trials; and for capital expenditures and working capital.

  • Fake News = The False Prophet

    GAITHERSBURG, Md., July 09, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has entered into a teaming agreement with DynPort Vaccine Company (DVC), a General Dynamics Information Technology (GDIT) company, to coordinate U.S. Government funding efforts and, if successful, to provide program management, drug development activity integration, and regulatory support for AdCOVID, Altimmune’s single-dose intranasal COVID-19 vaccine candidate.

    DVC has extensive experience in vaccine development and as the prime contractor and systems integrator for the preclinical, manufacturing, clinical and regulatory activities needed to secure FDA licensure of new drug products. DVC has supported vaccines and medical countermeasures for emerging diseases and bioterror threats under contracts with the Department of Defense, the Biomedical Advance Research and Development Authority (BARDA), and the National Institute of Allergy and Infectious Diseases (NIAID). The partnership with DVC significantly expands Altimmune’s capabilities to efficiently obtain and execute on U.S. Government funding opportunities to support the development of AdCOVID. Altimmune and DVC believe AdCOVID is an attractive vaccine candidate to government funding agencies based on its highly differentiated product profile.

  • Fake News = The False Prophet

    Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced it was awarded $4.7 million from the U.S. Army Medical Research & Development Command (USAMRDC) to fund its Phase 1/2 clinical trial of T-COVID, an investigational intranasal immune modulator for the treatment of outpatients with early COVID-19. The competitive award was granted by USAMRDC in collaboration with the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium working in partnership with the Department of Defense (DoD). The award is expected to provide Altimmune sufficient funding to cover the entire cost of conducting this clinical trial.

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