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CYNK-001 is a cryopreserved, allogeneic, off-the-shelf natural killer (NK) cell therapy derived from human placental CD34-positive hematopoietic stem cells. The product is enriched for CD56-positive and CD3-negative NK cells and is not genetically modified. CYNK-001 expresses activating receptors such as NKG2D, DNAM-1, NKp30, NKp44, and NKp46. These receptors enable the recognition of ligands on tumor or infected cells and trigger cytotoxic activity through the release of perforin and granzyme B to induce cell death. CYNK-001 also demonstrates immunomodulatory effects by secreting cytokines like IFN-gamma. It is being developed primarily for the treatment of hematologic malignancies (notably acute myeloid leukemia), solid tumors (including glioblastoma multiforme), and infectious diseases such as COVID-19[1][2][4][5][6]. The drug has received FDA fast track designation for acute myeloid leukemia and glioblastoma multiforme as well as orphan drug designation for malignant gliomas[1][5]. Developed by Celularity.
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