Clinical Trials

Date: 2015-09-21

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at the Inaugural CRI-CIMT-EATI-AACR Immunotherapy Conference in New York

Company: Nektar Therapeutics (USA - CA)

Product: NKTR-214

Action mechanism: cytokine/proteine/immunotherapy product. 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.  

Disease:

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

• • On September 21, 2015, Nektar Therapeutics announced positive preclinical results for NKTR-214, a CD122-biased cytokine designed to preferentially stimulate the production and maintenance of tumor-killing T cells. Results were presented at the Inaugural CRI-CIMT-EATI-AACR Immunotherapy Conference in New York. NKTR-214 shows efficacy in multiple preclinical models as a single agent. Combination regimens with NKTR-214 and either anti-CTLA4 or anti-PD-1 checkpoint inhibitor therapies resulted in durable anti-tumor immunotherapeutic effects, which persisted long after the termination of dosing. In a preclinical tumor re-challenge study presented, sequential dosing of anti-CTLA-4 followed by NKTR-214 resulted in durable and complete responses. At 142 days following the final dose, with no additional treatment, the complete responders demonstrated sustained resistance to multiple tumor re-challenges. In highly-resistant established melanoma tumor models, data presented show that treatment with NKTR-214 resulted in a controlled, sustained and biased T-cell activating signal and a mean ratio of CD8-positive T cells to T-regulatory cells ratio of 450:1 in the tumor infiltrating lymphocytes.

Is general: Yes