Adaptimmune Therapeutics, a clinical stage biopharmaceutical company based in Oxfordshire, U.K. and Philadelphia, has initiated a study of its affinity enhanced T-cell therapy targeting the NY-ESO-1 cancer antigen in patients with stage IIIb or stage IV non-small cell lung cancer (NSCLC), the most common type of lung cancer, representing 85% of lung cancers.
Adaptimmune is developing the affinity enhanced T-cell therapy targeting NY-ESO-1 under a collaboration agreement with GlaxoSmithKline.
“Lung cancer is the most common cancer worldwide and it is the leading cause of all cancer-related deaths, responsible for one in five cancer deaths. NSCLC accounts for the vast majority of these cancer deaths and thus represents a great unmet medical need,” said Dr. Rafael Amado, Adaptimmune’s chief medical officer. “Our NY-ESO TCR therapeutic candidate is being studied in a number of solid tumors and hematological malignancies including synovial sarcoma, multiple myeloma, melanoma, ovarian cancer and gastric and esophageal cancer, and we are excited to initiate this study in patients with NSCLC.”
Adaptimmune’s effort involves an open label clinical study in up to 10 patients with locally advanced or metastatic NSCLC and whose disease has progressed or not responded to prior therapies. The company expects to begin dosing of patients shortly.
Patients with the HLA-A*0201, HLA-A*0205, and/or HLA-A*0206 allele, whose tumor expresses the NY-ESO-1 tumor antigen, and who meet study entry criteria will be eligible to receive a single dose of autologous genetically modified T-cells expressing affinity optimized TCRs specific for NY-ESO-1. Though the prevalence of HLA sub-types varies from population to population, the most common in the Western world is HLA-A2. Among the HLA-A2 variants, the most prevalent are HLA-A*0201 and HLA-A*0206.
The primary objective of the study is to evaluate the safety and tolerability of Adaptimmune’s affinity enhanced T-cell therapy targeting NY-ESO in HLA-A*0201, HLA-A*0205 and/or HLA-A*0206 positive patients with NY-ESO-1 positive advanced NSCLC. Secondary objectives include evaluation of efficacy, measurement of persistence of genetically modified cells in the body, and evaluations of the phenotype and functionality of genetically modified cells isolated from peripheral blood or tumor post infusion.