On June 2, 2015 Nektar Therapeutics and The University of Texas MD Anderson Cancer Center reported a research collaboration that includes a Phase 1/2 clinical study to evaluate NKTR-214, a CD122-biased cytokine designed to preferentially stimulate production of CD8-positive T cells, which are tumor killing cells found naturally in the body (Press release, Nektar Therapeutics, JUN 2, 2015, View Source [SID:1234505210]). CD122, which is also known as the Interleukin-2 receptor beta sub-unit, is a key signaling receptor that is known to increase proliferation of these effector T cells.1 Schedule your 30 min Free 1stOncology Demo! "We are certain that cytokines are an essential pillar of immunotherapy, along with checkpoint inhibitors, adoptive T cell therapy and cancer vaccines," said Patrick Hwu, M.D., Division Head of Cancer Medicine at MD Anderson. "Through clinical studies, we will explore this new cytokine’s potential to preferentially activate an established target, the IL-2 receptor beta or CD122, in order to stimulate tumor cell killing within the tumor microenvironment. Collaborations with industry allow MD Anderson to pursue new treatment regimens that could dramatically improve patient treatment in the future."
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The agreement covers a Phase 1/2 study to evaluate NKTR-214 in a variety of tumor types as a monotherapy and in combination with other therapies, including PD-1 pathway inhibitors. Nektar and MD Anderson expect to initiate the first dose-escalation clinical study later this year. The two organizations will also conduct translational research to identify predictive biomarkers that can be used in the future development of NKTR-214.
"Nektar is pleased to collaborate with MD Anderson, a recognized leader in immuno-oncology, for clinical development of our lead immunotherapy candidate, NKTR-214," said Ivan Gergel, M.D., Senior Vice President and Chief Medical Officer of Nektar. "We believe NKTR-214 has great potential in different tumor types, both as a single agent and in combination with checkpoint inhibitors and other inhibiting agents. This new alliance with MD Anderson will significantly advance the development of NKTR-214 and help us to potentially offer a new and important therapeutic option for cancer patients."
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 Furthermore, although NKTR-214 is a cytokine, it is designed to be dosed on an antibody-like schedule similar to the dosing schedules for PD-1 and CTLA-4 agents.
About NKTR-214
NKTR-214 is a CD122-biased immune-stimulatory cytokine, which is designed to stimulate the patient’s own immune system to kill tumor cells. By biasing activation to the CD122 receptor, NKTR-214 enhances CD8+ memory effector T cells (tumor-killing cells) in the tumor. In preclinical studies, a single dose of NKTR-214 resulted in a 400-fold AUC exposure within the tumor compared with an equivalent dose of the existing IL-2 therapy, enabling, for the first time, an antibody-like dosing regimen for a cytokine.3 In dosing studies in non-human primates, there was no evidence of low blood pressure or vascular leak syndrome with NKTR-214 at predicted clinical therapeutic doses.4 NKTR-214 is currently completing final IND-enabling studies and is expected to begin clinical testing in the second half of 2015.