Altimmune Inc. came out Monday with more positive preclinical data for its Covid-19 vaccine candidate, setting up the Gaithersburg biopharma to take it to the clinic.
The preclinical data for the candidate, called AdCovid, “continue to look very promising, and if substantiated in the clinic, suggest that we could have a vaccine with important benefits compared to the current frontrunner vaccines now being tested,” Dr. Vipin Garg, president and CEO of Altimmune, said in an email to the Washington Business Journal.
The company, which reported initial positive results on the candidate about three months ago, expects to file an investigational new drug application with the Food and Drug Administration and kick off a phase 1 study in the fourth quarter of 2020. It would then aim to report data in the first quarter of 2021 — and, based on that data, “we would plan to move swiftly” into a phase 2 clinical trial next year, Garg said.
The studies, which Altimmune (NASDAQ: ALT) ran with the University of Alabama at Birmingham, found the candidate stimulated three types of immune system responses — called serum neutralizing, T-cell and mucosal immunity — meaning “all three arms of the immune system can work in concert to prevent and control infection,” Dr. Scot Roberts, chief scientific officer for Altimmune, said in a statement.
Nasal mucosal immunity represents “the front line of defense” against respiratory viruses like the coronavirus, and “may be critical to block both infection and transmission of Covid-19 to others,” Garg said.
Altimmune is using the same technology for its influenza vaccine candidate, which recently completed phase 2 clinical trials, and its anthrax vaccine candidate, which it’s developing under a $133.7 million Biomedical Advanced Research and Development Authority contract.
Altimmune’s stock was trading up 2.2% to $12.65 per share Monday afternoon.
AdCovid will join 42 other candidates now in clinical trials, including those from Novavax (NASDAQ: NVAX), AstraZeneca (NYSE: AZN) and Johnson & Johnson (NYSE: JNJ) — which Gaithersburg's Emergent BioSolutions (NYSE: EBS) is supporting — among others.
Altimmune is also advancing a coronavirus treatment, called T-Covid, a single-dose therapy for patients in the early stages of the disease. It’s now enrolling patients at several trial sites, Garg said, “and we anticipate having a potential data read-out in the fourth quarter, depending on the rate of enrollment.”
That treatment's progress follows the FDA’s June 1 authorization to initiate clinical studies after preclinical data that showed the candidate helped decrease inflammation in response to the infection. Altimmune is developing T-Covid under a $4.7 million contract with the U.S. Army Medical Research & Development Command. That’s expected to cover the cost of its phase 1 and 2 clinical trials.
T-Covid aims to minimize symptoms by activating the body’s immune response to the virus early, which would prevent the disease from worsening and requiring hospitalization, according to the company. But it could also be used preventatively and for other viruses, Garg told us in August. “Everybody’s fixated on a vaccine, and we agree, we need a vaccine, there’s no question. But we also need good therapeutics,” he said.
It all comes after Altimmune closed a $132.2 million public offering in mid-July, which “gives us a very strong hand, and gives us the ability to move these programs forward,” Garg said at the time. It had $80.3 million in cash, cash equivalents and short-term investments as of June 30.
