Altimmune Inc.’s ability to start clinical trials for its coronavirus vaccine candidate now lies in the hands of regulators.
The Gaithersburg biotech has submitted its investigational new drug application for its intranasal Covid-19 vaccine, AdCovid, to the Food and Drug Administration, the company said Wednesday. An approval would allow the company to initiate a phase 1 study of the candidate.
Altimmune (NASDAQ: ALT) is on track to kick off that trial in 2020 and report data in the first quarter of 2021, said President and CEO Vipin Garg in a statement. Based on that data, the company “would plan to move swiftly” into a phase 2 clinical trial next year, he told us previously.
“While the progress being reported with current vaccines is very encouraging, many in the scientific and medical communities agree that there is continued need for next-generation vaccines that offer significant enhancements,” he said in his statement Wednesday. “AdCovid has the potential to provide many benefits not offered by current vaccines, including simple intranasal administration (particularly well-suited for use in children), the ability to be transported at room temperature and conveniently stored in refrigerators for years, and the stimulation of nasal mucosal immunity with the potential to provide sterilizing immunity and block transmission of the SARS-CoV-2 virus.”
The company’s application also includes a preliminary proposal to evaluate the candidate in children, Garg said, “and we look forward to further discussions around our pediatric program with the FDA in the near future.”
Altimmune’s stock was trading up nearly 7% shortly after noon Wednesday to $9.88 per share.
The submission follows a previous meeting with the FDA in which it agreed to the clinical trial’s design, the patient population and manufacturing plans, according to Altimmune. The agency also confirmed the company wouldn’t need to perform additional studies beforehand.
It also comes on the back of positive preclinical results from studies of AdCovid with the University of Alabama at Birmingham. 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, 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.
Its pipeline moves forward as a slew of companies inch much closer to the potential finish line of the Covid-19 vaccine race: New York’s Pfizer Inc. (NYSE: PFE) and Germany’s BioNTech SE (NASDAQ: BNTX) have jointly filed for emergency use authorization with the Food and Drug Administration after disclosing strong efficacy for their vaccine candidate; Cambridge, Massachusetts-based Moderna Inc. (NASDAQ: MRNA) likewise came out with impressive results; and British pharmaceutical company AstraZeneca PLC (NASDAQ: AZN) and the University of Oxford announced positive findings Monday.
Gaithersburg’s Novavax, still with ground to cover, is now armed with a fast-track designation from the FDA for its Covid-19 vaccine candidate.
Still, all of these other vaccine contenders require injection, rather than administration through the nose. So while Altimmune’s won’t be the first to deliver, it would still bring value, Garg said previously.
“If everything lines up, we should have a vaccine in the second half of next year, and there may be other vaccines ahead of that,” he said, “and we hope so — we’re rooting for that.”
