SELLAS Life Sciences Group announced that it will present the results of a Phase 2 clinical trial evaluating the WT1 cancer vaccine in patients with malignant pleural mesothelioma (MPM) at the 13th International Conference of the International Mesothelioma Interest Group (iMig) 2016.
The oral presentation, “PL05.05: Randomized Phase II Study of Adjuvant WT1 Vaccine for Malignant Pleural Mesothelioma (MPM) After Multimodality Therapy,” will be given by Marjorie Zauderer, MD, on May 4. The results will also be presented as a poster at the Annual Meeting of the American Society of Clinical Oncology (ASCO), being held in Chicago, June 3–7. The iMig conference runs May 1–4 in Birmingham, U.K.
The WT1 vaccine (galinpepimut-S), 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 CD4+/CD8+ 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. The WT1 antigen 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 immune system responses, the vaccine is being developed to treat a broad spectrum of malignancies, including mesothelioma, acute myeloid leukemia, multiple myeloma, and ovarian cancer.
The Phase 2 double-blind, randomized study began by comparing the WT1 analog peptides vaccine in combination with montanide-adjuvant + granulocyte-macrophage colony-stimulating factor (GM-CSF), added to stimulate the immune response, versus montanide-adjuvant + GM-CSF in 39 patients with MPM. Due to a recommendation from the trial’s independent Data Monitoring Committee, the placebo arm was discontinued and only the WT1 vaccine arm was left open.
The trial’s ultimate goal was to determine if the WT1 vaccine, given in combination with other adjuvants, is safe and can help to prevent or delay mesothelioma from coming back after surgery and treatment. Based on the findings, which included reasonable safety and tolerability profiles, the company intends to initiate a Phase 2b/3 clinical trial on the vaccine in patients with MPM.
“We are very pleased that the most advanced clinical findings for our WT1 vaccine have been selected for presentations at ASCO and the upcoming iMig conference,” Angelos M. Stergiou, MD, chairman and chief executive officer of SELLAS, said in a press release. “In addition to our anticipated Phase 3 pivotal trials, SELLAS also plans to launch a broad program in additional solid tumors and hematological malignancies, including multiple Phase 2 studies we expect to commence later this year. Based on this progress, we anticipate a steady flow of clinical trial readouts over the next two years.”
SELLAS is a biopharmaceutical company developing therapeutic agents for cancer and central nervous system diseases.