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AlloVir gets green signal to initiate clinical trial for ALVR109 in COVID-19

September 17, 2020

The FDA has signed off AlloVir’s (ALVR +6.0%) Investigational New Drug application (IND) for ALVR109, an allogeneic, off-the-shelf virus-specific T cell therapy candidate against SARS-CoV-2.

In March, the company 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 IND submission for ALVR109, the FDA put a clinical hold due to questions related to raw materials used in the manufacturing process for ALVR109.

BCM submitted a complete response and the FDA has removed the hold allowing the clinical study to start.

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