Sana says FDA okays new new drug IND application for SC291 B-cell study

Sana Biotechnology announced the U.S. Food and Drug Administration FDA has cleared the company’s Investigational New Drug IND application to initiate a first-in-human study of SC291 in patients with various B-cell malignancies. SC291 is a CD19-targeted allogeneic CAR T cell therapy developed using Sana‘s hypoimmune platform. The goal of the hypoimmune platform is to overcome the immunologic rejection of allogeneic cells, which if true for SC291 may result in longer CAR T cell persistence and a higher rate of durable complete responses for patients with B-cell lymphomas or leukemias. The hypoimmune platform includes disruption of major histocompatibility class I and MHC class II expression to hide cells from the adaptive immune system, which includes antibody and T cell responses, as well as overexpression of CD47 to inhibit activation of the innate immune cell system, in particular macrophages and natural killer cells. The company has presented data across multiple preclinical models highlighting the potential of this platform to cloak cells from immune recognition and the potential of SC291 as a therapeutic for patients with B-cell malignancies.