June 2, 2023

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“Ready-to-use” placenta-derived NK cell therapy fast-track qualification

“Ready-to-use” placenta-derived NK cell therapy fast-track qualification


FDA grants “ready-to-use” placenta-derived NK cell therapy the fast-track qualification.

On December 27, 2021, Celularity announced that the US FDA has granted the natural killer (NK) cell therapy CYNK-001 fast track qualification for the treatment of acute myeloid leukemia (AML).

CYNK-001 is a cryopreserved “ready-to-use” NK cell therapy based on hematopoietic stem cells derived from allogeneic human placenta.


AML is one of the most common leukemias in adults, accounting for about one-third of all cases. As a rapidly progressing blood and bone marrow cancer, cancerous white blood cells in AML patients grow rapidly.

Not only can they not perform normal functions, but they also affect the production of normal blood cells.

The 5-year survival rate of AML patients is also the lowest among all leukemia types, with high unmet medical needs.


NK cells are an important immune cell in the human body and participate in physiological processes such as anti-tumor, anti-viral infection and immune regulation.

About 5%-15% of human peripheral blood leukocytes are NK cells. Unlike T cells and B cells, NK cells are part of the natural immune system.

They can quickly and directly kill tumor cells without recognizing tumor-specific antigens, and they have stronger cytotoxicity.


FDA grants "ready-to-use" placenta-derived NK cell therapy the fast-track qualification.

▲Celularity’s product pipeline (picture source: Celularity’s official website)


Over the years, Celularity has extracted and generated a wide range of powerful stem cells and progenitor cells from human placenta, which can differentiate into almost all cell types in the body.

In addition, they can also be used as biological materials for immunotherapy. Some unique immunobiological characteristics of placental organs make it a professional allograft of nature, which means that it is possible to put placental cells from any donor into any recipient without matching.

In addition, the immune properties of the placenta can provide a high degree of protection against cancer and infectious diseases.


CYNK-001 is derived from allogeneic, placental hematopoietic stem cells that have not been modified by gene editing. As a “ready-to-use” NK cell therapy, it is expected to treat a variety of blood system cancers, solid tumors and infectious diseases.

Previously, CYNK-001 has been granted orphan drug designation by the FDA for the treatment of malignant gliomas (malignant gliomas) and fast track designation for the treatment of glioblastoma multiforme (GBM).



Reference materials:

[1] Celularity Receives Fast Track Designation from U.S. FDA for its NK Cell Therapy CYNK-001 in Development for the Treatment of AML。Retrieved December 27, 2021


(source:internet, reference only)

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