Sana Biotechnology, Inc. announced the publication in Blood of an abstract providing initial clinical data from the first patient treated at the lowest dose in the ongoing ARDENT Phase 1 clinical trial with SC291, a hypoimmune (HIP)-modified allogeneic CD19-directed CAR T cell therapy. SC291 appeared safe and well tolerated, evaded immune detection, and induced a partial response in a patient with chronic lymphocytic leukemia (CLL). ARDENT is a Phase 1 study evaluating safety and tolerability of SC291 in patients with CLL and non-Hodgkin lymphoma.

Treatment in this dose escalation study is ongoing, and the company expects to present more data from this study at a later date in an appropriate venue. SC291 is a hypoimmune, CD19-directed allogeneic CAR T cell therapy derived from healthy donor CD4+ and CD8+ T cells that are genetically engineered. SC291 is developed with Sana?s hypoimmune platform, which is designed 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 technology includes disruption of major histocompatibility (MHC) class I and MHC class II expression to allow cells to evade the adaptive immune system, which includes antibody and T cell responses, as well as overexpression of CD47 to evade the innate immune cell system, in particular macrophages and natural killer (NK) 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. SC291 is being evaluated in a Phase 1 study called ARDENT for patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL).