SELLAS Life Sciences Group Receives a Favorable Opinion for European Orphan Drug Designations for WT1 Cancer Vaccine (galinpepimut-S) for the Treatment of Acute Myeloid Leukemia and for Malignant Pleural Mesothelioma
ZUG, Switzerland and NEW YORK, April 5, 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 the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has rendered a favorable opinion as regards Orphan Drug Designation for the Company's WT1 cancer vaccine (galinpepimut-S) for the treatment of patients with acute myeloid leukemia (AML) and patients with malignant pleural mesothelioma (MPM). Earlier this year, the U.S. Food and Drug Administration granted SELLAS's WT1 vaccine Orphan Drug Designation to treat MPM and AML.
"The orphan designations for galinpepimut-S, both in the US and now the European Union, underscore the important unmet needs in treating patients with MPM and with AML," said Angelos M. Stergiou, M.D., Chairman and Chief Executive Officer of SELLAS. "SELLAS is dedicated to advancing novel therapies that we believe can make a significant difference in the lives of desperately ill patients. We are proud of the progress of our WT1 vaccine program, and we expect to initiate pivotal studies of the WT1 vaccine in both MPM and AML later this year, as well as additional mid-stage studies in diverse indications."
SELLAS recently reported positive results of a Phase 2 trial of its WT1 vaccine in MPM patients, showing that overall survival improved and progression-free survival doubled. Based on these findings, SELLAS intends to initiate a pivotal Phase 2b/3 trial of its product candidate in patients with MPM by the third quarter of 2016.
In addition, the Company expects to begin a pivotal Phase 3 Study of its WT1 vaccine in AML patients by the second quarter of 2016. A median overall survival of around 4 years was achieved in a Phase 2 trial of the WT1 vaccine in adult patients with AML. Similarly, in a previous Phase 1 AML study, the WT1 vaccine resulted in a median overall survival of more than 3 years. When combined, the results from the Phase 1 and Phase 2 studies demonstrated a 2-year overall survival in adult AML patients of 79%. Historical 2-year overall survival results in similar patient populations range from 30% to 45%.
"Given a favorable opinion for both indications despite them being submitted a month a part is truly unique", says Chief Regulatory Officer and VP, Operations Gregory M. Torre, PhD, JD. "It speaks not only to the strength of the data but the interest of the COMP in these serious and life threatening indications", Dr Torre continued.
Orphan Drug Designation by the EC provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU), and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, Orphan Drug Designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.
About SELLAS's WT1 Cancer Vaccine
SELLAS' WT1 vaccine is a late clinical-stage cancer immunotherapy being developed to target hematologic cancers and solid tumors, including acute myeloid leukemia (AML), mesothelioma (MPM), multiple myeloma, ovarian cancer, and multiple other cancers. The WT1 antigen is a transcription factor that is not generally expressed in normal adult cells, but appears in a large number of cancers, as well as in certain cancer stem cells. WT1 has been ranked by the National Cancer Institute (NCI) as the Number 1 target for cancer immunotherapy. While WT1 has not been druggable by traditional approaches, it can be targeted by the immune system. Specifically, a number of different peptide sequences from the WT1 antigen have been identified as immunogenic and capable of stimulating cytotoxic T-cells that can target and kill WT1-expressing cancer cells. Studies also have shown that WT1 does not provoke tolerization and that patients' T-cells can remain reactive to the antigen over time.
The WT1 vaccine, originally developed by Memorial Sloan Kettering Cancer Center and licensed to SELLAS, comprises four modified peptide chains that induce a strong innate immune response (CD4+/CD8+ T-cells) against the WT1 antigen. The WT1 vaccine is administered in combination with an adjuvant and an immune modulator to improve the immune response to the target. Based on its mechanism and the accumulating evidence of activity in mid-stage trials, the WT1 vaccine may have the potential to complement currently available therapies by destroying residual tumor cells of cancers in remission and providing ongoing immune surveillance for recurrent tumors. Overall, SELLAS' WT1 vaccine could target over 20 cancers that over-express WT1, many of which are associated with relapse rates of up to 80% or more, as seen in patients with AML and MPM.
About SELLAS Life Sciences Group
SELLAS Life Sciences is a development-stage biopharmaceutical company focused on innovative products to treat cancer and central nervous system (CNS) diseases. SELLAS has two Phase 2b- and 3-ready products poised to enter trials in Europe and the US in 2016, across multiple indications in cancer and CNS diseases, as well as an earlier-stage highly innovative cancer therapeutic. The company recently received orphan drug designations by the US FDA for its WT1 cancer vaccine in Acute Myeloid Leukemia and Malignant Pleural Mesothelioma which will enter into pivotal clinical trials in 2016.
SELLAS's WT1 vaccine, licensed from Memorial Sloan Kettering Cancer Center, is a cancer immunotherapeutic agent targeting a broad spectrum of hematologic cancers and solid tumor indications. This program will advance into Phase 3 trials in 2016 in AML and MPM as well as other indications in various development phases, including ovarian cancer, glioblastoma multiforme, and others with WT1 vaccine alone or in combination with other immunooncology agents. SELLAS is also advancing a proprietary formulation of high-dose Zolpidem under the 505(b)(2) pathway to treat basal ganglia disorders, including Parkinson's disease and Progressive Supranuclear Palsy (PSP), which is the lead orphan indication. Zolpidem's mechanism of action and therapeutic effects in such CNS-related diseases have been demonstrated in several studies. SELLAS expects to initiate a Phase 2b study of high-dose Zolpidem for PSP in 1H 2016. A third program is focused on SELLAS's TR1 product candidate, a novel fusion protein that supplies the normal wild type p53/p21 protein to cancer cells to trigger innate cell death mechanisms (apoptosis). The Company is advancing its TR1 program toward IND-enabling studies, with the goal of commencing Phase 1 testing by early 2017.
SELLAS was founded in 2012 and is headquartered in Zug, Switzerland, with additional offices in New York, USA.
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SOURCE SELLAS Life Sciences Group
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