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www.fdanews.com/articles/181065-fda-grants-orphan-drug-designation-for-nantkwests-ank-cell-therapy

FDA Grants Orphan Drug Designation for NantKwest’s aNK Cell Therapy

March 24, 2017

NantKwest has received orphan drug designation from the FDA for its activated natural killer (aNK) cell therapy for treatment of patients with advanced Merkel cell carcinoma.

The drug uses three different modes of action to kill cancer cells: (1) direct killing using activated NK cells that release toxic granules directly into the cell through cell-to-cell contact; (2) antibody-mediated killing using haNKs, which are NK cells engineered to enhance the cancer cell killing effect of an antibody; and (3) targeted activated killing using taNKs, which are NK cells engineered to target tumor-specific antigens found on the surface of cancer cells.

The drug is currently in Phase II clinical trials at clinical sites in the U.S. treating subjects with metastatic or locally advanced Merkel cell carcinoma.

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