Sana Biotechnology, Inc. announced the U.S. Food and Drug Administration has cleared the company?s Investigational New Drug application to initiate a study of SC291 in patients with multiple B-cell mediated autoimmune diseases, including lupus nephritis, extrarenal lupus, and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. SC291 is a CD19-directed allogeneic CAR T cell therapy developed using Sana?s hypoimmune platform. allogeneic T cell programs utilize T cells from healthy donors to generate CAR T therapies that, in this case, target CD19, a protein expressed on the cell surface of B cells.

It has been shown that B cells drive disease pathology in many autoimmune diseases, and B-cell targeting therapies from several different modalities have been efficacious across multiple autoimmune diseases. Emerging data in the field support the concept that deeper tissue B cell depletion can be associated with greater efficacy and a reasonable safety profile. CD19-directed CAR T therapy introduces a new option, where the CAR T is the effector cell that depletes B cells in situ.

goal is to develop SC291 in various settings, using existing hypoimmune allogeneic CAR T manufacturing platform, to deliver with scale for these large unmet needs. Sana?s hypoimmune platform is designed to create cells ex vivo that can ?hide? from the patient?s immune system to enable the transplant of allogeneic cells without the need for immunosuppression.

are applying the hypoimmune technology to both donor-derived allogeneic T cells, with the goal of making potent and persistent CAR T cells at scale, and pluripotent stem cells, which can then be differentiated into multiple cell types at scale. Preclinical data published in peer-reviewed journals demonstrate across a variety of cell types that these transplanted allogeneic cells are able to evade both the innate and adaptive arms of the immune system while retaining their activity. most advanced programs utilizing this platform include an allogeneic CAR T program targeting CD19+ cancers, an allogeneic CAR T program for B-cell mediated autoimmune diseases, an allogeneic CAR T program targeting CD22+ cancers, and stem-cell derived pancreatic islet cells for patients with type 1 diabetes.