Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D; community with critical information on the tools, technologies, and trends that drive the biotech industry.
Issue link: http://gen.epubxp.com/i/155541
Translational Medicine Clinical Trials Cancer > Adaptimmune opened a Phase I/IIa, multiple-site, two-cohort, and open-label clinical trial in ovarian cancer. Researchers will investigate the safety, bioactivity, and efectiveness of treating patients with their own T cells after genetically engineering the cells to enhance their antitumor properties. During the trial, T-cell receptors (TCRs) that have been developed using Adaptimmune's TCR enhancement technology will be deployed to target two CT antigens, NYESO-1 and LAGE-1. They will be transferred to the patients' T cells in a process for autologous T-cell manufacturing developed by Carl June, M.D., and Bruce Levine, Ph.D., at the Perelman School of Medicine at the University of Pennsylvania. Infusion of the CT antigen-specific T cells will occur following a brief treatment with relatively high dose of "lymphodepleting" chemotherapy to prepare the patient's immune system for the genemodifed T cells. A total of six patients will be enrolled in the ovarian trial. Only patients capable of responding to the therapy—those with the correct tissue marker (HLA-A*0201) Adaptimmune is focused on the use of T-cell therapy to treat cancer and infectious disease. formerly Cloning & Stem Cells Professor Sir Ian Wilmut, OBE, FRS, FRSE Editor-In-Chief vative nal to provide inno d jour isms emier peer-reviewe The pr ing cellular mechan ramm ncements in reprog adva Sign up for TOC Alerts www.liebertpub.com/cell 52 | September 1, 2013 | GENengnews.com | Genetic Engineering & Biotechnology News and whose tumor expresses NY-ESO-1 and/or Lage-1—will be enrolled. > BIND Therapeutics dosed the frst patient in a Phase II trial to assess the safety and efcacy of BIND-014, a PSMAtargeted Accurin containing docetaxel, as second-line therapy in patients with nonsmall-cell lung cancer. The 40 patient, open-label, single-arm, multicenter study is designed to determine the efcacy of BIND-014 as measured by objective response rate in patients with Stage III/IV non-small-cell lung cancer who have failed one prior platinum-containing chemotherapy regimen for advanced or metastatic disease. > ImmunoCellular Therapeutics initiated a Phase I trial of cancer vaccine ICT-121 as a potential treatment for patients with recurrent glioblastoma multiforme (GBM). ICT-121 is a dendritic cell vaccine targeting CD133. The primary objective of the openlabel study is to assess the safety and tolerability of ICT-121. Secondary objectives include overall survival (OS) and progressionfree survival (PFS) at six months after surgery as well as other response parameters. Approximately 20 patients who have had gross tumor resection and experienced a frst recurrence of GBM, and who are HLA-A2 positive, will be treated in the trial. Patients will be administered the vaccine once per week for four weeks during the induction phase, followed by a maintenance phase consisting of one treatment every two months until their supply of vaccine is depleted or they experience progressive disease. > Nektar Therapeutics completed enrollment in a clinical study of etirinotecan pegol (NKTR-102) in patients with metastatic breast cancer. The Phase II openlabel, randomized, multicenter study, also known as the BEACON trial, is evaluating etirinotecan pegol versus a single-agent treatment of physician's choice for the treatment of locally recurrent or metastatic breast cancer. Etirinotecan pegol is the frst long-acting topoisomerase I inhibitor designed to concentrate in tumor tissue to provide sustained tumor suppression throughout the entire chemotherapy cycle, according to the company. Approximately 840 women with locally recurrent or metastatic breast cancer, who have previously been treated with an-