Nektar Submits Investigational New Drug Application (IND) for NKTR-214 To Treat Solid Tumor Malignancies

Nektar Therapeutics

today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NKTR-214, its lead immuno-oncology candidate. NKTR-214 is a CD122-biased immune-stimulatory cytokine that is designed to stimulate the patient's own immune system to destroy cancer cells. The company plans to initiate a Phase 1/2 clinical study by the end of 2015. The study will evaluate the safety, tolerability and efficacy of NKTR-214 in patients with solid tumor malignancies and will include expansion cohorts that will evaluate NKTR-214 both as a single-agent and in combination with a checkpoint inhibitor. "As a new cytokine with biased receptor activity and an antibody-like dosing schedule, NKTR-214 could emerge as a differentiated immuno-oncology therapy that specifically stimulates T-cell growth to fight cancer," said Stephen Doberstein, PhD, Senior Vice President and Chief Scientific Officer of Nektar. "In preclinical studies with NKTR-214, we not only observed single-agent efficacy in multiple tumor models, but when administered in combination with a checkpoint inhibitor, we see a dramatic immune-educating vaccine-like effect with NKTR-214. We are excited to start our first-in-human study and we expect to have initial data from the dose-escalation phase of the trial by the second half of 2016." The Phase 1/2 clinical program will be conducted at multiple clinical sites including MD Anderson Cancer Center and Yale Cancer Center. In addition to the Phase 1/2 clinical program, Nektar and MD Anderson will conduct translational research to identify predictive biomarkers that can be used in the future development of NKTR-214.