Adaptimmune Therapeutics (ADAP) Announces NY-ESO SPEAR Actively Recruiting Under Amended Protocol; Offers Update

October 12, 2016 9:16 AM EDT
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Adaptimmune Therapeutics plc (Nasdaq: ADAP) announced that its amended protocol using its NY-ESO SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell therapy in ovarian cancer patients with treatment resistant or refractory metastatic ovarian cancer is now actively recruiting.

To date, no objective clinical responses have been reported in the ovarian cancer patients who received NY-ESO SPEAR T-cell therapy in the initial iteration of this trial. Of note, these initial patients received a preconditioning regimen which consisted of cyclophosphamide alone, rather than including fludarabine. Data from Adaptimmune’s studies of its NY-ESO SPEAR T-cell therapy in synovial sarcoma patients have indicated the importance of including fludarabine in the preconditioning regimen. The use of fludarabine appears to be required for expansion, response and persistence of transduced cells. As a result, this trial will enroll patients under a revised protocol including a pre-conditioning regimen that includes fludarabine in combination with cyclophosphamide.

"Based on our clinical experience to date, we have amended the protocol for this trial to include both fludarabine and cyclophosphamide in the conditioning regimen," said Dr. Rafael Amado, Adaptimmune’s Chief Medical Officer. “We hope that, as previously observed in synovial sarcoma, this lymphodepleting regimen will enable anti-tumor immune responses mediated by NY-ESO SPEAR T-cell therapy in these patients with advanced chemotherapy relapsed or refractory ovarian cancer."

This is a Phase I/IIa, open-label study of autologous T-cells genetically engineered with an enhanced affinity NY-ESO-1 T-cell receptor in ovarian cancer patients with the HLA-A*0201, HLA-A*0205, and/or HLA-A*0206 allele and whose tumor expresses the NY-ESO-1 tumor antigen. 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.

This multi-center study is intended to enroll up to 10 additional patients under the revised protocol, and will assess the safety and tolerability of Adaptimmune’s NY-ESO SPEAR T-cell therapy in patients with treatment resistant or refractory metastatic ovarian cancer expressing the NY-ESO-1 antigen. Secondary objectives will include the assessment of clinical efficacy, measurements of durability of persistence of NY-ESO SPEAR T-cells in the blood, and exploratory tumor biomarker studies, and evaluations of the phenotype and functionality of NY-ESO-1 SPEAR T-cells.

For more information on this clinical trial, visit at: (Identifier: NCT01567891).

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