GAITHERSBURG, Md., Sept. 28, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that Scot Roberts, Ph.D., Chief Scientific Officer of Altimmune, Inc., presented an overview of the Company’s AdCOVID and T-COVID intranasal vaccine and therapeutic candidates during a special COVID-19 virtual session of the World Vaccine Congress Washington, taking place September 28 – October 1, 2020.
A link to Dr. Roberts’ presentation is available on Altimmune’s website at www.altimmune.com. The presentation can be accessed under the ‘Investors’ section of the website under ‘Events and Presentations.’
The World Vaccine Congress Washington 2020 brings together global leaders from industry, academia and public health to advance the development of vaccine technologies. This year’s conference features a special COVID-19 segment dedicated to expanding knowledge to facilitate the rapid development of vaccines to address the global COVID-19 pandemic.
AdCOVID is a single-dose intranasal vaccine candidate for COVID-19 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.
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, a durable immune response of a year or more, and the ability to ship and store the vaccine conveniently and inexpensively.
By utilizing the Company’s proprietary intranasal vaccine technology, AdCOVID has the potential to activate multiple arms of the immune system as shown in recent preclinical studies where potent serum neutralizing antibody and T cell responses were induced in addition to a robust induction in mucosal immunity against the spike protein of the virus. Importantly, the mucosal immunity was characterized by IgA antibody and resident memory T cell responses in the respiratory tract, both are believed to be important in fighting infection.
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 eliminating 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 anticipates 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.
T-COVID is a therapeutic candidate based on the same vaccine platform technology supporting Altimmune’s intranasal vaccine candidates, but it works through the mechanism of immune modulation.
In preclinical animal studies, T-COVID modulated the innate immune response to decrease lung inflammation and significantly lower concentrations of inflammatory cytokines in response to respiratory virus infection. Excessive production of inflammatory cytokines has been associated with lung pathology and death in COVID-19.
T-COVID is administered as a single intranasal dose and has the potential to be self-administered. Unlike the majority of therapeutic interventions for COVID-19, T-COVID is focused on non-hospitalized patients prior to the development of pulmonary dysfunction or the need for hospitalization. In this way T-COVID is used to prevent more severe disease instead of attempting to reverse it. Early intervention with T-COVID is expected to modulate the innate immune response to infection, blocking the progression to severe disease. T-COVID has a demonstrated stability profile that may allow for cold chain-free distribution and common refrigerator storage in community-based doctor’s offices and pharmacies for two years or more.
T-COVID is currently being evaluated in a Phase 1/2 clinical study called the ‘EPIC’ trial (Efficacy and Safety of T-COVID in the Prevention of Clinical Worsening in COVID-19). EPIC is expected to enroll approximately 100 patients and will evaluate the potential protective effects of T-COVID to prevent clinical worsening in patients with early COVID-19.
Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. The Company’s 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, statements regarding the impact of COVID-19 on our business operations, clinical trials and results of operations, the timing of key milestones for our clinical assets, the development of our AdCOVID vaccine product candidate, submitting an IND with the U.S. Food and Drug Administration and commencing of a Phase 1 clinical study in Q4 2020 for AdCOVID, the development of our T-COVID therapeutic candidate and enrollment of patients in our EPIC trial, 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 Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: potential impacts due to the COVID-19 pandemic such as delays in clinical trial enrollment, regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to obtain potential regulatory approvals on the timelines anticipated, or at all; the Company’s ability to obtain additional patents or extend existing patents on the timelines anticipated, or at all; the Company’s ability to identify and consummate potential future strategic partnerships; and the Company’s ability to expand its pipeline of products and the success of future product advancements, including the success of future clinical trials, and the Company’s ability to commercialize its products. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, which are available at www.sec.gov.
Ashley R. Robinson
Chief Financial Officer
LifeSci Advisors, LLC
Sard Verbinnen & Co.