SELLAS Life Sciences Announces Positive WT1 Cancer Vaccine (galinpepimut-S) Clinical Results at the 13th International Conference of the International Mesothelioma Interest Group (iMig)

– In a randomized, double-blind Phase 2 trial, SELLAS’s galinpepimut-S demonstrated improvement in overall survival and doubling of progression-free survival in mesothelioma patients – SELLAS plans to initiate a pivotal Phase 2b/3 study of WT1 vaccine in mesothelioma patients by 3Q 2016 ZUG, Switzerland and NEW YORK, May 4, 2016 /PRNewswire/ — SELLAS Life Sciences Group (SELLAS), a development-stage biopharmaceutical company with its main focus on developing innovative products to treat cancers and central nervous system (CNS) diseases, today announced that results from a Phase 2 trial of the Company’s WT1 cancer vaccine in patients with malignant pleural mesothelioma (MPM) were presented at the plenary session of the iMig 2016 Conference, being held May 1-4, 2016, in Birmingham, UK. SELLAS’s galinpepimut-S is a late clinical-stage cancer immunotherapy being developed to target hematologic cancers and solid tumors, including MPM, acute myeloid leukemia (AML), multiple myeloma, ovarian cancer, and multiple other cancers. As reported in an oral plenary session presentation at this week’s iMig Conference, treatment with galinpepimut-S in a randomized, double-blind, placebo-controlled Phase 2 trial conducted at Memorial Sloan Kettering Cancer Center (MSK) and M.D. Anderson Cancer Center resulted in improved overall survival in patients with MPM and doubling of progression-free survival: The trial showed a median overall survival of 21.4 months for WT1 vaccine-treated patients versus a median 16.6 months overall survival for patients in the placebo control arm. The WT1 cancer vaccine also resulted in a median progression-free survival of 11.4 months, double that of the control arm, 5.7 months, in patients with MPM. The WT1 vaccine demonstrated a favorable safety and tolerability profile in MPM patients. Patients with a complete tumor resection and subsequent treatment with galinpepimut-S showed a significant survival benefit Patients who mounted an immune-response with galinpepimut-S had a significant survival benefit Galinpepimut-S was very well tolerated by patients in this trialBased on these results, SELLAS is preparing to initiate a pivotal Phase 2b/3 trial of its WT1 vaccine in patients with MPM by the third quarter of 2016.”The results of the WT1 cancer vaccine clinical program have been encouraging, demonstrating enhanced survival and a favorable safety profile in patients,” said Marjorie G. Zauderer, M.D., a medical oncologist at MSK and principal investigator for the trial. “Our goal in this approach is to ensure that patients can stay longer in complete remission by activating the body’s own immune response against their cancer cells expressing the WT1 antigen. We believe that in a larger trial, as anticipated, we will gain a clearer picture of the potential impact of this promising therapy in a patient population with few treatment options.”David A. Scheinberg, M.D., Ph.D., an inventor of the WT1 vaccine, as well as Chair of the Molecular Pharmacology Program and Director of the Experimental Therapeutics Center at MSK, commented, “We have built a large body of laboratory data and clinical evidence demonstrating that the WT1 vaccine can have a clinically significant impact on patients with MPM, as well as individuals with other cancers, such as AML. We look forward to entry of this program into pivotal testing in MPM patients, as well as a second pivotal study anticipated in AML patients in the first half of this year.”

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