On December 8, 2015 Nektar Therapeutics (NASDAQ:NKTR) reported that dosing has commenced in the Phase 1/2 clinical study evaluating the efficacy and safety of NKTR-214 in the treatment of solid tumors (Press release, Nektar Therapeutics, DEC 8, 2015, View Source [SID:1234508491]). Schedule your 30 min Free 1stOncology Demo! NKTR-214 is a novel CD122-biased cytokine designed to preferentially activate the beta and gamma sub-units of the IL-2 receptor in order to proliferate tumor-killing T cells within the body (CD8-positive effector T cells and natural killer T cells) without stimulating regulatory T cells (CD4-positive T cells).
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"NKTR-214 is a unique immuno-oncology candidate that is specifically designed to activate and multiply the patient’s own tumor-killing T cells in order to fight cancer more effectively," said Ivan Gergel, M.D., Senior Vice President and Chief Medical Officer of Nektar. "With NKTR-214 in preclinical models, we observed a preferential increase of CD8-positive effector T cells of more than 400-fold compared to regulatory T cells within the tumor itself. We are excited about the start of the clinical study and the potential of NKTR-214 to provide a positive benefit for patients with cancer."
The Phase 1/2 study of NKTR-214 is designed to evaluate patients with advanced solid tumors, including melanoma, renal cell carcinoma and non-small cell lung cancer. The study is being conducted initially at two primary investigator sites: MD Anderson Cancer Center under Drs. Patrick Hwu and Adi Diab; and Yale Cancer Center, under Drs. Mario Sznol and Michael Hurwitz.
NKTR-214 is designed to be administered similarly to the dosing schedules for approved PD-1 and CTLA-4 agents, and will be evaluated on a once every three week dosing schedule in the Phase 1/2 clinical trial. In preclinical studies, NKTR-214 demonstrated a mean ratio of 450:1 within the tumor micro-environment of CD8-positive effector T-cells, which promote tumor killing, compared with CD4-positive regulatory T cells, which are a type of cell that can suppress tumor killing.2
About the NKTR-214 Phase 1/2 Study
The dose-escalation stage of the Phase 1/2 study is designed to evaluate safety, efficacy, and define the recommended Phase 2 dose of NKTR-214 in approximately 20 patients with solid tumors. In addition to a determination of the recommended Phase 2 dose, the study will assess preliminary anti-tumor activity, including objective response rate (ORR). The immunologic effect of NKTR-214 on tumor-infiltrating lymphocytes (TILs) and other immune infiltrating cells in both blood and tumor tissue will also be assessed. Following the dose-escalation stage of the study, dose expansion cohorts are planned to evaluate NKTR-214 in specific tumor types, including melanoma, renal cell carcinoma and non-small cell lung cancer.
For more information on the NKTR-214 Study, please visit the "Clinical Trials" section of www.mdanderson.org using identifier 2015-0573.
At MD Anderson Cancer Center, Patrick Hwu, M.D. serves as Head, Division of Cancer Medicine; Chair, Melanoma Medical Oncology and Chair, Sarcoma Medical Oncology and Adi Diab, M.D. serves as Assistant Professor, Department of Melanoma Medical Oncology and Division of Cancer Medicine. Mario Sznol, M.D., is Professor of Medicine (Medical Oncology) at Yale Cancer Center and also Co-Director of the Yale SPORE in Skin Cancer. Michael Hurwitz, M.D. serves as Assistant Professor of Medicine, Medical Oncology at Yale Cancer Center.