The U.S. Food and Drug Administration (FDA) has approved Fast Track Designation for Celularity’s stem cell-derived natural killer (NK) cell therapy, CYNK-001, in the development for the treatment of acute myeloid leukemia (AML). AML is a type of blood cancer in which a large number of abnormal myeloblasts are made in the bone marrow and can quickly move throughout the blood stream. Celularity’s CYNK-001 is a non-genetically modified cryopreserved human placental hematopoietic allogeneic unmodified NK cell therapy being developed as a treatment for hematologic malignancies, solid tumors, and infectious diseases. AML is the most common form of leukemia found within the adult sector of the population and a common treatment for this cancer is chemotherapy. Celularity is a clinical stage biotechnology company that specializes in cellular medicine, specifically the development of allogeneic cryopreserved off-the-shelf placental-derived cell therapies, including therapeutic programs using unmodified natural killer (NK) cells, genetically modified NK cells, T-cells engineered with a CAR (CAR T-cells), and mesenchymal-like adherent stromal cells (ASCs), to target indications of cancer and infectious and degenerative diseases.

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