“It stops replication of the virus and its transmission,” Garg said of his company’s experimental vaccine. “Injectables might reduce transmission, but we need to block transmission if we’re going to stop the pandemic.”
Not only will AdCOVID reduce transmission of the virus, should it prove efficacious in clinical studies, Garg said its administration will make it highly convenient for many people who are averse to receiving an injection. If it’s ultimately approved for pediatric use, he said it will certainly appeal to children who do not want to receive shots from the doctor. In addition to its ease of use, Garg said AdCOVID is room temperature stable and can be stored in a refrigerator for up to two years. The AdCOVID treatment is similar to the recently authorized vaccine developed by Johnson & Johnson, an adenovirus medication that does not require cold storage.
The ongoing Phase I clinical trial is assessing the vaccine against the original strain of the virus. Altimmune has also been constructing vaccine cell lines with different variants of SARS-CoV-2 for future studies. Garg said the company wants to be ready for every possibility in the battle against the pandemic.
Altimmune anticipates a readout from the Phase I study soon, and if all goes well, Garg expects to immediately begin Phase II. Phase III could be different than other vaccine studies due to declining number of non-vaccinated patients. Garg said it is possible by the time AdCOVID is ready to enter Phase III, there will be enough information available to predict clinical efficacy of a vaccine based on its antibody generation. That surrogate endpoint could be included in late-stage studies in order to expedite potential approval of AdCOVID, which could be ready for commercialization in the latter part of this year, or in early 2022.
In addition to Altimmune’s AdCOVID asset, the company is also developing vaccines for influenza and anthrax that use the same technology as the COVID-19 medication. In December, Altimmune began a multinational Phase II clinical trial of HepTcell, which is being conducted in the United States, Canada and Europe. Also, the company began dosing patients in a Phase I study of ALT-801, a novel GLP-1/glucagon dual-agonist being evaluated for the treatment of Non-Alcoholic SteatoHepatitis (NASH), a fatty-liver disease. Primary endpoints in the study include weight loss, which Garg suggested will have a significant impact on NASH, a disease that many companies have struggled to target over the past few years.
“If we can come up with a drug that will meaningfully reduce body weight, that could impact NASH,” he said.
As Altimmune moves forward with its COVID-19 vaccine program, Garg noted the leading role the Maryland life sciences ecosystem has taken in the battle against the pandemic.
“There is a cluster of companies in Maryland that are making a significant impact in fighting the pandemic,” he said. Garg added that federal health programs, such as the National Institutes of Health and the U.S. Food and Drug Administration, both of which are in Maryland, gave the region an additional edge in the battle against COVID-19. And that edge will be important for the future.
“We need a vibrant biotech industry because there will be another pandemic and we will need to be able to respond to those challenges,” Garg said.