Sana Biotechnology Announces FDA Clearance of Investigational New Drug Application for SC291


Seattle-based company Sana Biotechnology (Sana) received FDA clearance for its Investigational New Drug application aimed at treating “patients with multiple B-cell mediated autoimmune diseases,” according to a company press release. 

The drug, SC291, is a cell therapy that operates by repurposing T cells from healthy donors to target B cells, which are known to contribute to the creation of autoimmune diseases in the body. SC291 is specifically designed for patients suffering from lupus (lupus nephritis and extrarenal lupus) and ANCA-associated vasculitis, a group of uncommon autoimmune diseases. 

“Our goal is to develop SC291 for patients with multiple B-cell mediated autoimmune diseases, and the clearance of this IND is an important milestone,” said Doug Williams, PhD, Sana’s President of Research and Development. “SC291 is an allogeneic CAR T cell therapy with a scaled manufacturing process that produces hundreds of patient doses per manufacturing run, which we believe will be critical to addressing these large unmet needs.”