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Nektar, Cellular Biomedicine Partner to Develop Combo TIL Therapy in NSCLC

NEW YORK – Nektar Therapeutics on Wednesday said it has begun a collaboration with Cellular Biomedicine Group to evaluate Nektar's interleukin-15 receptor agonist with Cellular Biomedicine's tumor-infiltrating lymphocyte therapy C-TIL051 in a Phase I clinical trial in non-small cell lung cancer.

In the trial conducted by Cellular Biomedicine, investigators will evaluate the safety and efficacy of C-TIL051, NKTR-255, and Merck's anti-PD1 antibody Keytruda (pembrolizumab) in about 20 patients with NSCLC who are resistant to anti-PD1 therapy. The primary outcome measure of the trial will be the incidence of adverse events or dose-limiting toxicities. As secondary outcomes, investigators will track objective response rate, duration of response, progression-free survival, and overall survival. Nektar will provide a supply of NKTR-255 for the trial. The companies will retain existing rights to their respective medicines.

Development of C-TIL051 was based on prior preclinical and clinical studies including a Phase I pilot study of Bristol Myers Squibb's Opdivo (nivolumab) followed by tumor infiltrating lymphocyte therapy in patients with metastatic NSCLC, in which three out of 13 evaluable patients had confirmed responses and 11 had reduction in tumor burden.

The companies believe that the addition of an interleukin-15 receptor agonist could enhance proliferation and persistence of the cellular therapy, leading to increased anti-tumor activity. San Francisco-based Nektar is also studying NKTR-255 as a cellular therapy adjuvant in a Phase II/III trial evaluating NKTR-255 with CD19-directed CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma. And in one arm of a Phase II umbrella trial being conducted by EMD Serono and Merck KGaA, researchers are assessing Merck's PD-L1 antibody Bavencio (avelumab) with NKTR-255 as a treatment for patients with advanced urothelial carcinoma.