SAN FRANCISCO—Nektar Therapeutics has teamed up with The University of Texas MD Anderson Cancer Center in a research collaboration that includes a Phase 1/2 clinical study to evaluate NKTR-214. The study will evaluate the compound in a variety of tumor types, both as a monotherapy and in combination with other therapies, including PD-1 pathway inhibitors. The organizations plan to begin the first dose-escalation clinical study later this year, and will also be conducting translational research to identify predictive biomarkers that could 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," Dr. Ivan Gergel, senior vice president and chief medical officer of Nektar, said in a press release. "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 advancethe development of NKTR-214 and help us to potentially offer a new and important therapeutic option for cancer patients."
Nektar's NKTR-214 is a CD122-biased immune-stimulatory cytokine designed to stimulate a patient's immune system to kill tumor cells. The compound preferentially stimulates the production of CD8-positive memory effector T cells, tumor-killing cells that are naturally occurring in the human body. CD122, which is also referred to as the Interleukin-2 receptor beta sub-unit, is a key signaling receptor that is known to increase the proliferation of these effector T cells.
In preclinical studies of NKTR-214, a single dose of the agent led to a 400-fold AUC exposure in the tumor compared with an equivalent dose of the existing IL-2 therapy, which allowed for an antibody-like dosing regimen for a cytokine for the first time. Dosing studies in non-human primates demonstrated no evidence of low blood pressure or vascular leak syndrome with NKTR-214 at predicted clinical therapeutic doses. The compound is undergoing its final IND-enabling studies, and clinical testing should begin in the second half of this year.
"We are certain that cytokines are an essential pillar of immunotherapy, along with checkpoint inhibitors, adoptive T cell therapy and cancer vaccines," commented Dr. Patrick Hwu, division head of Cancer Medicine at MD Anderson, in a statement about the collaboration. "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."
In other recent partnering news for MD Anderson, the institute signed an option agreement with Astellas Pharma in April for the research and development of a new treatment for acute myeloid leukemia (AML) patients. The collaboration will focus on h8F4 technology, a humanized monoclonal antibody invented by MD Anderson’s Dr. Jeffrey Molldrem. MD Anderson will conduct Phase 1a and 1b studies, and Astellas will have an option to firstly negotiate an exclusive worldwide license at the end of Phase 1b. The agreement includes up to $26 million as an option premium and for R&D funding.