On Jun. 29, 2020, Altimmune 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.

As previously announced, patient enrollment in the T-COVID Phase 1/2 trial is expected to commence in the coming weeks, with data readout expected in the fourth quarter of 2020. If the Phase 1/2 clinical trial is successful, the Company plans to initiate a Phase 2/3 trial of T-COVID early next year and commence discussions regarding a potential Emergency Use Authorization.

On June 1, Altimmune announced that the U.S. Food and Drug Administration (FDA) authorized the Company to proceed with a clinical trial of T-COVID, which is based on the same technology supporting Altimmune’s intranasal vaccine candidates, including AdCOVID for COVID-19, NasoShield for anthrax and NasoVAX for influenza. T-COVID is differentiated from most other COVID-19 therapeutics currently in development as it is focused on non-hospitalized patients prior to the development of pulmonary dysfunction with a goal to prevent the progression to severe lung inflammation and thereby decrease the development of severe COVID-19 and the need for hospitalization.

The T-COVID therapeutic program complements the Company’s novel single-dose COVID-19 vaccine candidate, AdCOVID, that utilizes the Company’s proprietary intranasal vaccine technology and has the potential to prevent infection by activating multiple arms of the immune system. On May 13, Altimmune announced the initiation of AdCOVID preclinical studies at the University of Alabama at Birmingham (UAB). Multiple candidates of the AdCOVID vaccine are currently being evaluated at UAB, and the topline immunogenicity results are expected to identify the best vaccine candidate for manufacturing and clinical development. The Company intends to initiate manufacturing in July with the Phase 1 clinical trial expected to begin in Q4 of this year.

T-COVID is based on the same replication-deficient adenovirus 5 (RD-Ad5) vector technology supporting Altimmune’s intranasal vaccine candidates, which include AdCOVID for COVID-19, NasoShield for anthrax and NasoVAX for influenza, but it works through the mechanism of immune modulation. In preclinical animal studies T-COVID modulated the innate immune response to decrease inflammation and significantly lower concentrations of IL-6 and other inflammatory cytokines in response to infection with respiratory viruses. Excessive production of inflammatory cytokines like IL-6 has been associated with the lung pathology and death in COVID-19.