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NantKwest and ImmunityBio to Initiate a Phase 2 Study of Immunotherapy for Metastatic Pancreatic Cancer
Open-label, randomized Phase 2 study will evaluate combination immunotherapy, including NantKwest’s PD-L1 tumor-targeted natural killer cells and
About this update from Immunitybio, Inc.
[{"type":"text","content":"\n\nOpen-label, randomized Phase 2 study will evaluate combination immunotherapy, including NantKwest’s PD-L1 tumor-targeted natural killer cells and ImmunityBio’s IL-15 superagonist N-803 with standard of care versus standard of care alone\n\n\nMetastatic pancreatic cancer patient treated with PD-L1 t-haNK and N-803 through a single patient IND has ongoing, durable, complete response six months after initial treatment\n\n\nThe study has received FDA authorization and is expected to begin in June 2020\n\n\n EL SEGUNDO, Calif.--(BUSINESS WIRE)--\nNantKwest, Inc. (Nasdaq: NK), a clinical-stage, natural killer cell-based therapeutics company, and ImmunityBio, a privately-held immunotherapy company, today announced plans for a Phase 2, randomized, open-label study to evaluate the efficacy and safety of their combination immunotherapy: NantKwest’s PD-L1 t-haNK, ImmunityBio’s N-803, and aldoxorubicin HCI plus standard of care, versus standard-of-care chemotherapy for first- and second-line treatment of locally advanced or metastatic pancreatic cancer.\n\n\nFour metastatic pancreatic cancer patients have been treated with PD-L1 t-haNK and N-803 under single patient INDs, with two patients on treatment for an evaluable period. One patient reported ongoing, durable, complete response six months after treatment, and one observed response of stable disease. The Investigational New Drug (IND) application has received authorization from the U.S. Food and Drug Administration (FDA) with the study anticipated to begin in June 2020.\n\n\n“Our results from expanded access use of PD-L1 t-haNK in combination with N-803 offer proof-of-concept that, together with these agents, the immune system may play a role to activate robust and durable responses in metastatic cancer patients who have failed all standard-of-care therapies,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. “Based on these encouraging data, we are moving forward with a randomized Phase 2 program that will evaluate our immunotherapy combination on top of standard of care, compared to standard of care alone, in first- and second-line treatment settings. This unique approach to orchestrating the innate and adaptive immune systems to induce immunogenic cell death may be an important new approach for pancreatic cancer patients—these bein...