SELLAS Life Sciences Group announced that its WT1 vaccine, a clinical-stage immunotherapy for a wide range of hematologic cancers and solid tumors, including malignant pleural mesothelioma, has been approved to be named galinpepimut-S by the United States Adopted Names Council of the American Medical Association.
The council selects simple and unique, nonproprietary names for drugs so as to standardize and unify drug nomenclature.
The WT1 vaccine, originally developed by Memorial Sloan Kettering Cancer Center and licensed to SELLAS, is composed of four modified peptide chains that stimulate specific immune cells, such as cytotoxic T-cells, to respond against the WT1 antigen, which is generally not expressed in healthy adult cells but appears in large quantities in many cancers. WT1 has been ranked by the National Cancer Institute (NCI) as the No. 1 target for cancer immunotherapy.
Administered with an adjuvant and an immune modulator to improve the immune system responses, the vaccine is being developed for a broad spectrum of malignancies, including mesothelioma, acute myeloid leukemia (AML), multiple myeloma, and ovarian cancer.
SELLAS previously reported promising results from a Phase 2 clinical trial evaluating the vaccine’s effect on the survival of patients with malignant pleural mesothelioma. The trial compared a WT1 vaccine combination treatment to a control treatment, and results indicated the vaccine extended overall survival and doubled progression-free survival. Based on these findings, which included reasonable safety and tolerability profiles, the company intends to initiate a Phase 2b/3 WT1 vaccine study in malignant pleural mesothelioma patients later this year.
“We expect 2016 to be an exceptional year for the progress of our advanced-stage WT1 program,” Miltiadis Sougioultzoglou, MD, vice chairman and executive vice president of SELLAS, said in a press release. “Over the course of the next three quarters, we anticipate announcing the start of two pivotal studies, in MPM [malignant pleural mesothelioma] and AML, as well as multiple Phase 2 studies in additional solid tumors and hematological malignancies. We also expect to have a steady flow of clinical trial readouts from this program in 2016 and 2017, with the intention of demonstrating the potential of the WT1 vaccine in diverse indications where there is compelling clinical need.”