US NK Cell Therapy Receives FDA Grant of Orphan Drug Status

[ China Pharmaceutical Network Technology News ] Orphan drugs refer to drugs, diagnostic reagents and vaccines that treat diseases of less than 200,000 US citizens. Under the FDA's Orphan Drug Act, orphan drugs can be quickly approved, tax deductible, exempt from filing fees, research and development grants, and seven years of market exclusivity. It is reported that on March 20, Nant Kwest, a cancer immunotherapy company in the United States, announced that the self-developed activated NK cell therapy for the treatment of advanced Merkel cell carcinoma has been granted orphan drug status by the US Food and Drug Administration (FDA).

(US NK cell therapy was granted FDA status as an orphan drug. Image source: Baidu image)

NK cells (natural killer cells) are important immune cells of the body, not only related to anti-tumor, anti-viral infection and immune regulation, but also participate in hypersensitivity and autoimmune diseases in some cases. NantKwest's NK cell therapy is currently in Phase 2 clinical trials in the United States for the treatment of patients with metastatic or locally advanced Merkel cell carcinoma.

Merkel cell carcinoma is a highly malignant tumor originating from the skin. It is called neuroendocrine cancer in the cytoplasm of the tumor. It is also called neuroendocrine cancer originating from the skin. It mainly occurs in the head and neck of the elderly. And limbs, with unique ultrastructural changes and immunohistochemical staining characteristics. The trial protocol for this Merkel cell carcinoma has just been modified to include a synergistic study of the IL-15 superactivator ALT-803, which has been shown to improve and enhance NK cell activity in preclinical trials. And to enhance the synergistic potential of patients with autologous NK cell activity, the future clinical phase 2 trial will continue to conduct research on the ALT-803 combined activation of NK cell therapy.

It is reported that orphan drugs refer to drugs, diagnostic reagents and vaccines for treating diseases of less than 200,000 US citizens. Under the FDA's Orphan Drug Act, orphan drugs can be quickly approved, tax deductible, exempt from filing fees, research and development grants, and seven years of market exclusivity. Dr. Patrick Soon-Shiong, CEO and President of NantKwest, said: "We firmly believe that the status of orphan drugs granted by the FDA, together with the ongoing phase II trial data of advanced Merkel cell carcinoma, is even more solid. Phase 2 trials have the confidence to transition to FDA critical clinical trials."

Founded on October 7, 2002 in Illinois, USA, NantKwest is a groundbreaking clinical phase cancer immunotherapy development company focused on the treatment of cancer, infectious diseases, inflammatory diseases, and innate immune system diseases through the use of NK cells. At present, all products are in preclinical and clinical I/II, and were successfully listed on NASDAQ in the United States on July 27, 2015.