Allogeneic CAR T Cleared for B-cell Malignancy Trials


Sana Biotechnology also plans to submit another IND for the same indications for a CD22-targeted CAR T later in 2022.

The FDA has cleared Sana Biotechnology’s investigational new drug application (IND) for SC291, a CD19-targeted allogeneic chimeric antigen receptor (CAR) T-cell therapy for the potential treatment of various B-cell malignancies.1

“The clearance of our SC291 IND is an important milestone, putting us closer to our goal of making an important medicine for patients with B-cell lymphomas and leukemias,” Steve Harr, President and chief executive officer, Sana Biotech, said in a statement.1 “We look forward to understanding the safety, potency, and persistence of these cells in patients, and we are optimistic that SC291 can become an important medicine for patients with these difficult cancers. Furthermore, this platform forms the backbone for additional development of CAR T cells targeting CD22, BCMA, and beyond. We expect initial clinical data from the SC291 study later this year and believe insights from this study will better inform our opportunities across the broader platform, both for CAR T cells and for programs outside of cancer such as our pancreatic islet cell therapy for patients with type 1 diabetes.”

SC291 is developed with the use of Sana Biotechnology’s hypoimmune platform that is designed to address immunologic rejection of allogeneic cells with the body, and Sana believes the platform could yield longer CAR T persistence and higher, more durable complete response rates in B-cell lymphomas and leukemias. The platform addresses rejection by disrupting major histocompatibility (MHC) class I and MHC class II expression to hide cells from the adaptive antibody and T cell responses. The platform also overexpresses CD47 to inhibit activation of innate immune responses with macrophages and natural killer cells. Preclinical studies of the platform have demonstrated its ability to cloak cells from immune recognition, meanwhile, preclinical studies of SC291 have supported its potential as a therapy for B-cell malignancies.

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Sana Biotechnology also revealed plans to submit another IND for SC262, a CD22-targeted allogeneic CAR T therapy also developed with the hypoimmune platform for the same potential indications of SC291, B-cell malignancies including non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL). Sana is also developing cell therapies for multiple myeloma, diabetes, central nervous system diseases, and hemoglobinopathies.

“We are making significant progress with our platforms to address two of the fundamental opportunities to enable greater utilization of cell engineering to treat serious diseases – overcoming immune rejection of allogeneic cells and in vivo delivery of gene modification reagents in a cell-specific manner. We look forward to generating human proof of concept starting next year and are positioning the company to invest fully based upon the clinical data,” Harr said in a previous statement.2

1. Sana Biotechnology announces FDA clearance of investigational new drug application for SC291, a hypoimmune-modified, CD19-targeted allogeneic CAR T therapy for patients with B-cell malignancies. News release. Sana Biotechnology. January 26, 2023.
2. Sana Biotechnology confirms key program timelines and announces portfolio prioritization. News release. November 29, 2022.
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