Geron Initiates Clinical Trial of Telomerase Cancer Vaccine in Patients with Acute Myelogenous Leukemia.
Study Builds on Positive Data Previously Generated in Metastatic Prostate Cancer Patients
Protocol Under Geron's IND is First to Employ Prime-Boost Regimen to Extend Duration of Telomerase Immunity
MENLO PARK, Calif. -- Geron Corporation (Nasdaq:GERN) announced today the initiation of a clinical trial of its telomerase cancer vaccine, GRNVAC1, in patients with acute myelogenous leukemia (AML) in complete remission.
The vaccine is produced from a patient's blood using a unique process that generates highly activated dendritic cells (DC) that contain RNA coding for the protein component of telomerase. This new approach to cancer immunotherapy has been clinically shown to safely generate high levels of cytotoxic lymphocytes that kill telomerase positive cancer cells after as few as six weekly injections into the skin.
The primary objective of this new Phase I/II study is to evaluate the safety and feasibility of a prime-boost vaccination regimen that extends the duration of telomerase immunity. Secondary objectives are to evaluate the immune response to GRNVAC1 and to explore the effects of vaccination on minimal residual disease and relapse rates. A total of six sites in the United States are planned to participate in this multi-center trial.
"AML is an appropriate indication for investigating a cancer immunotherapy that targets telomerase because of high telomerase expression in AML cells, the great unmet clinical need, especially in older patients who frequently relapse after chemotherapy, and the low tumor burden after consolidation chemotherapy," said John DiPersio, M.D., Ph.D., chief of the Division of Oncology and deputy director of the Siteman Cancer Center at Washington University School of Medicine, St. Louis, who is the study's lead investigator. "Patients at high risk of relapse are in need of additional therapies that are well tolerated. This study is an important step in understanding the role that immunotherapy directed against telomerase might play in cancer treatment."
Alan Colowick, M.D., Geron's president, oncology, said, "We are excited to begin this multi-center study in AML patients who have a high risk for relapse. A great deal of work has enabled us to apply and extend the initial clinical findings for GRNVAC1 in prostate cancer to AML patients. We have scaled and modified the manufacturing of the vaccine to enable a multi-site design with central manufacturing. In addition, we have optimized the prime-boost regimen to enhance the duration of immunity to telomerase in previous clinical studies, and we have demonstrated successful ex vivo DC activation and loading with telomerase antigen in samples taken from patients with AML. We look forward to investigating the tolerability and potential clinical utility of GRNVAC1 in patients with AML."
