SELLAS Life Sciences Group Announces Initiation of Galinpepimut-S (WT1 Cancer Vaccine) Phase 1 Clinical Trial in Combination with PD-1 Checkpoint Inhibitor for Patients with Ovarian Cancer

– Trial Will Evaluate Galinpepimut-S Combined with Nivolumab to Treat Patients with Advanced-Stage Disease – – Combination Therapy Builds on Previous Promising Results of WT1 Vaccine Monotherapy in Blood Cancers and Solid Tumors – ZUG, Switzerland and NEW YORK, April 29, 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 the initiation of a Phase 1 clinical trial to evaluate the safety and efficacy of SELLAS’s galinpepimut-S in combination with nivolumab (Opdivo®), Bristol- Myers Squibb’s PD-1 immune checkpoint inhibitor. The Phase 1 study is expected to enroll at least ten patients with recurrent ovarian cancer who are in second or greater clinical remission at Memorial Sloan Kettering Cancer Center. Ovarian cancer is one of the most common gynecologic malignancies and the fifth most frequent cause of cancer death in women in the United States. Over 22,000 cases are diagnosed annually, and there are an estimated 15,500 deaths per year. Patients enrolled in the Phase 1 study will receive the combination therapy during the trial’s 14-week treatment period. Individuals who have not progressed by the end of this period will also receive a maintenance course of the WT1 vaccine. Pending the successful progress of the trial a larger, follow-on, randomized study may be planned. “For patients with advanced-stage ovarian cancer, the five-year survival rate is less than 30%, and there is a substantial and urgent need for new treatments that can prolong remission and survival in patients,” said Roisin O’Cearbhaill, MD, MBBCh, BAO at Memorial Sloan Kettering and principal investigator for the trial. “Galinpepimut- S is a promising treatment for this disease because of WT1 showing an expression in ovarian cancer, and we believe T-cells, by combining galinpepimut-S and nivolumab, may specifically be directed towards the WT1 target and supports the rationale for its use in cancer immunotherapy approaches. In fact, studies have confirmed that ovarian cancer patients can exhibit immunologic competence even after multiple courses of chemotherapy, and immune activation has been shown to portend a better prognosis for these patients. We are excited to initiate clinical studies of galinpepimut-S in this cancer immunotherapy application and look forward to the progress of the program.” Promising clinical results for SELLAS’s WT1 vaccine as monotherapy have been reported in peer-reviewed forums in both solid tumors (malignant pleural mesothelioma (MPM)) and hematological cancers (acute myeloid leukemia (AML) and multiple myeloma (MM)). Based on this progress, SELLAS is commencing pivotal Phase III clinical trials of galinpepimut-S in AML patients and MPM patients this year. Angelos M. Stergiou, M.D., Chairman and Chief Executive Officer of SELLAS, commented, “We are advancing a broad clinical program with galinpepimut-S to expand potential indications and develop in parallel applications for monotherapy and combined therapy in hematologic cancers and solid tumors. By the end of this year, we expect to have two pivotal trials and additional mid-stage studies in diverse indications, including a series of genetically defined Mismatch Repair cancers in a basket-trial design.” Dr. Stergiou added, “We are very pleased to further broaden our successful clinical trials program with our collaborator MSK, and by extension to now integrate the leading anti-PD-1 product in our trial in ovarian cancer.” About SELLAS’s WT1 Cancer Vaccine

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