Shanghai-Based NK CellTech Earns FDA IND Clearance for Non-Genetically Modified NK Cell Therapy

NK CellTech, a Shanghai-based developer of NK cell therapies, has announced that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its proprietary non-genetically modified natural killer cell therapy, NK010, for the treatment of ovarian cancer. This milestone marks NK CellTech as the first Chinese company to have a non-genetically-modified allogeneic peripheral blood NK cell product approved for clinical trials in the US.

NK010 boasts significant anti-cancer benefits, including an optimized receptor spectrum, diverse target sites, high purity, and universality, which position it as a potential treatment for a variety of tumor types. The therapy also holds promise for the treatment of non-tumor diseases and serves as an ideal base for a range of subsequent synthetic NK cell drugs (SynNK). Preclinical studies have demonstrated NK010’s robust anti-tumor activity against solid tumors such as ovarian and liver cancer, as well as in animal models of acute myeloid leukemia.- Flcube.com

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