Gaithersburg vaccine company Altimmune Inc. got the Food and Drug Administration’s go-ahead to kick off clinical trials for its experimental Covid-19 vaccine candidate — a nasal spray rather than a shot in the arm typical of existing Covid vaccines.
Altimmune said Wednesday it expects to start enrollment for the phase 1 trial of its AdCovid vaccine candidate “in the coming week” — less than three months after the company submitted its application to the regulatory agency.
The local company’s stock closed Wednesday at $24.31 per share — up nearly 14% — following the news earlier in the day.
The FDA’s clearance of its investigational new drug application “marks an important step” as the race to develop safe, effective Covid vaccines ramps up in a global effort to help stem the disease's spread, said Altimmune President and CEO Vipin Garg. The trial sets out to assess the experimental vaccine’s safety and ability to provoke the body’s immune response, with plans to enroll up to 180 healthy adults ages 18 to 55, the company said.
That positions Altimmune (NASDAQ: ALT) to report data later this quarter. And if it's successful, the company “would plan to move swiftly” into a phase 2 study with more participants, Garg told us in the fall.
The company is working with a fast-expanding Rockville biotech, Vigene Biosciences Inc., to manufacture AdCovid.
Altimmune is using the same technology in AdCovid that it did for both its flu 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.
The vaccine maker, which is doubling its staff to 50 employees and expanding its headquarters, is also enrolling participants in a study of T-Covid, its single-dose therapy for patients in the disease’s early stages.
Of course, Altimmune’s candidate is hardly the first to cross the finish line; vaccines from partners Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX), as well as another from Moderna Inc. (NASDAQ: MRNA), are already reaching patients. Other companies such as AstraZeneca PLC (NASDAQ: AZN) and Johnson & Johnson (NYSE: JNJ) could be on deck. And Gaithersburg’s Novavax Inc. (NASDAQ: NVAX) has entered a rolling review process with the FDA and others globally after reporting positive data in the U.K., even as it continues its late-stage clinical trial in the U.S.
But playing the long game has its advantages, Garg told us last year. “We just know so little about this virus at this point that we can’t declare victory after the first vaccine candidate. We have to let it play out so we can have the best, most optimal vaccine candidate to fight this pandemic.”
