FDA Clears Imviva’s Dual-Target CAR-T for Autoimmune Diseases

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By Karen Roman

Imviva Biotech said the FDA cleared its Investigational New Drug application for CTA313, a dual-targeted CAR-T therapy for the treatment of B-cell-mediated autoimmune diseases.

Phase 1b of this clinical trial will study CTA313 in patients with systemic lupus erythematosus, progressive multiple sclerosis, and autoimmune encephalitis, among other autoimmune conditions, the company stated.

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“One of the most exciting aspects of our allogeneic approach is that CTA313 can be manufactured in advance and made readily available,” said Jan Davidson-Moncada, MD, PhD., Imviva Biotech’s Chief Medical Officer. “Our off-the-shelf approach means eligible patients could potentially receive treatment more quickly.”