FDA clears IND application for T-cell therapy to treat high-risk patients with COVID-19
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The FDA cleared an investigational new drug application for ALVR109 for the treatment of high-risk adults with COVID-19 infection, according to the agent’s manufacturer.
ALVR109 (AlloVir) is an allogeneic, virus-specific T-cell therapy that targets SARS-CoV-2 — the virus that causes the novel coronavirus — to limit the progression of COVID-19. The SARS-CoV2-specific T cells are derived from healthy donors who have recovered from COVID-19.
“SARS-CoV-2 continues to have a devastating impact on patients and families around the world,” David Hallal, chairman and CEO of AlloVir, said in a company-issued press release. “There is an increasing body of evidence about the important role of T cells in the body’s fight against COVID-19,” he added. “Together with our colleagues at Baylor College of Medicine, we are working with a great sense of urgency to leverage our highly innovative virus-specific T-cell platform to advance ALVR109 into a proof-of-concept study in high-risk COVID-19 patients.”
In March, AlloVir announced its partnership with Baylor College of Medicine to develop an off-the shelf cellular therapy to treat patients with COVID-19.
An IND for ALVR109 previously submitted by Baylor College of Medicine was put on a clinical hold when the FDA had questions about the raw materials used in the therapy’s manufacturing process. Baylor’s responses to the FDA’s queries led to a lift of this hold and the pending start of the phase 1 clinical trial.
Phase 1 of the trial will identify the maximum tolerated dose of ALVR109 for adults with COVID-19 who are at high risk of requiring mechanical ventilation. The dose-finding phase will be followed by a randomized trial to determine the efficacy of ALVR109 compared with standard-of-care treatment.
AlloVir officials said they expect to begin enrollment in the phase 1 study of ALVR109 by the fourth quarter of this year.
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