Date: 2016-09-27
Type of information: Clinical research agreement
Compound: Opdivo® (nivolumab) and NKTR-214
Company: Nektar Therapeutics (USA - CA) BMS (USA - NY)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: cytokine/proteine/immunotherapy product/monoclonal antibody/immune checkpoint inhibitor. Opdivo® (nivolumab) is an investigational human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. NKTR-214 is a CD122-biased immune-stimulatory cytokine, which is designed to stimulate the patient's own immune system to eliminate cancer cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase the proliferation of CD8-positive effector T cells, and these CD8-positive T cells comprise a key component of the tumor infiltrating lymphocytes that provide cell-mediated anti-tumor effects. By biasing activation to the CD122 receptor, NKTR-214 enhances CD8-positive T cells (tumor-killing cells) in the tumor. In preclinical studies, a single dose of NKTR-214 resulted in an approximate 400-fold AUC exposure within the tumor compared with an equivalent dose of aldesleukin, an existing IL-2 therapy. This increase potentially enables, for the first time, an antibody-like dosing regimen for a cytokine. 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. Nektar and BMS are collaborating to develop NKTR-214 as a potential combination treatment regimen with Opdivo® (nivolumab) in five tumor types and eight potential indications. The Phase 1/2 clinical program will enroll up to 260 patients and will evaluate the potential for the combination of Opdivo (nivolumab) and NKTR-214 to show improved and sustained efficacy and tolerability above the current standard of care in melanoma, kidney, triple-negative breast cancer, bladder and non-small cell lung cancer patients. The initial dose-escalation trial is underway with Opdivo (nivolumab) and NKTR-214 in the indications of first-line melanoma, second-line RCC checkpoint therapy-naïve, and second-line non-small cell lung cancer (NSCLC) checkpoint therapy-naïve.
Disease: melanoma, kidney cancer, colorectal cancer, bladder cancer, non-small cell lung cancer
Details: * On September 27, 2016, BMS and Nektar Therapeutics announced a new clinical collaboration to evaluate BMS' Opdivo® (nivolumab) with Nektar's investigational medicine, NKTR-214, as a potential combination treatment regimen in five tumor types and seven potential indications. The Phase 1/2 clinical trials will evaluate the potential for the combination of Opdivo® and NKTR-214 to show improved and sustained efficacy and tolerability above the current standard of care in melanoma, kidney, colorectal, bladder and non-small cell lung cancer patients. An initial dose-escalation trial is underway with Opdivo® and NKTR-214.
Financial terms: BMS and Nektar will equally share costs of the combined therapy trials. Nektar will maintain its global commercial rights to NKTR-214.
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