According to a press release, Angelos Stergiou, MD, CEO and chairman of SELLAS Life Sciences, will make the presentation at 10 a.m. (PT), Monday, Jan. 9 at the Westin St. Francis Hotel.
SELLAS is the developer of the WT1 vaccine (galinpepimut-S), originally created by Memorial Sloan Kettering Cancer Center and later licensed to the company. The breakthrough vaccine is composed of four modified peptide chains that stimulate specific immune cells, such as CD4+/CD8+ T-cells, to respond against the WT1 antigen, usually not expressed in healthy adult cells, but appears in large quantities in many cancers, including mesothelioma. 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 WT1 vaccine is being developed to treat a broad spectrum of malignancies, including mesothelioma.
In September 2016, the U.S. FDA granted Fast Track designation to the WT1 vaccine as a possible treatment of malignant pleural mesothelioma. This action followed the FDA placing galenpepimut-S on “fast track,” or accelerated development, for the treatment of acute myeloid leukemia in June 2015.
The cancer vaccine has been shown to extend overall survival and double progression-free survival of patients with malignant pleural mesothelioma. These promising results came from a randomized Phase 2 clinical trial (NCT01890980) that compared the safety and effectiveness of a WT1 vaccine combination treatment to a control treatment. Specifically, the results showed a median overall survival of 24.8 months for WT1 vaccine-treated patients, versus 16.6 months overall survival for patients in a placebo control group. The company presented data from this Phase 2 malignant pleural mesothelioma study at the 2016 Annual Meeting of the American Society of Clinical Oncology and the 2016 International Mesothelioma Interest Group.
Based on these Phase 2 findings, which included reasonable safety and tolerability profiles, SELLAS is planning to begin a Phase 2b/3 double-blind, placebo-controlled, multi-center and multinational study, designed to assess efficacy and safety of the vaccine in patients with malignant pleural mesothelioma.