– ALVR109 is an allogeneic, off-the-shelf virus-specific T cell therapy candidate designed to target SARS-CoV-2 for high-risk COVID-19 patients– Proof-of-concept clinical trial with ALVR109 to begin in Q42020CAMBRIDGE, Mass., Sept. 17, 2020 (GLOBE NEWSWIRE) — AlloVir (Nasdaq: ALVR), a late clinical-stage cell therapy company, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for ALVR109, an allogeneic, off-the-shelf virus-specific T cell therapy candidate designed to target SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19. ALVR109 is being developed to arrest the progression of COVID-19 by eradicating SARS-CoV-2 virus-infected cells.“SARS-CoV-2 continues to have a devastating impact on patients and families around the world,” said David Hallal, Chairman and Chief Executive Officer of AlloVir. “There is an increasing body of evidence about the important role of T cells in the body’s fight against COVID-19. At AlloVir, 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.”Early research suggests that T cells play an important role in the body’s fight against COVID-19. Over 80% of hospitalized patients with COVID-19 are lymphopenic, with reduced CD8+ and CD4+ T cell counts. These reductions in T cell counts correlate negatively with survival. Reduced T cell counts have been observed to be prevalent in older COVID-19 patients and those with severe illness, regardless of age.On March 23, 2020, AlloVir announced it expanded its research collaboration with Baylor College of Medicine (BCM) to discover and develop allogeneic, off-the-shelf, virus-specific T-cell therapies for COVID-19. Following the submission of the IND for ALVR109 by BCM, the FDA notified BCM of a clinical hold due to questions related to raw materials used in the manufacturing process for ALVR109. BCM submitted a complete response to the questions identified in the clinical hold and the FDA has removed the hold allowing the clinical study to start.About AlloVir
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