ZUG, Switzerland and NEW YORK, May 24, 2016 /PRNewswire/ -- SELLAS™ Life Sciences Group (SELLAS™), a development-stage biopharmaceutical company with its main focus on developing innovative products to treat cancer, today announced that results from a Phase 2 trial of the Company's WT1 cancer vaccine, galinpepimut-S, in patients with acute myeloid leukemia (AML) will be presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO), being held in Chicago, IL, June 3-7, 2016. SELLAS™ also will present a poster detailing Phase 2 results of its WT1 cancer vaccine for the treatment of patients with malignant pleural mesothelioma (MPM). In addition, SELLAS™ announced today that ZELTHERVA has been formally accepted by the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research as the proprietary name for SELLAS™'s cancer vaccine. SELLAS™'s WT1 vaccine is a late clinical-stage cancer immunotherapy being developed to target hematologic cancers and solid tumors, including AML, MPM, multiple myeloma, ovarian cancer, and multiple other cancers. Based on the results of its mid-stage clinical program, SELLAS™ expects to begin a pivotal Phase 3 trial of its WT1 vaccine in AML patients and a pivotal Phase 2b/3 trial of its WT1 vaccine in patients with MPM later this year.
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2016 ASCO Oral Presentation Details: | |
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Title: |
Phase II trial of WT1 analog peptide vaccine in adults with acute myeloid leukemia (AML) in first complete remission (CR) (Abstract No. 7005) |
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Authors: |
Maslak P, Dao T, Bernal Y, Chanel S, Zhang R, Frattini M, Rosenblat T, Jurcic J, Brentjens R, Rampal R, Park J, Douer D, Katz LM, Gutierrez A, Tallman M, Scheinberg DA; Memorial Sloan Kettering Cancer Center, SELLAS™ Life Sciences Group |
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Session: |
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant |
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Date & Time: |
Saturday, June 4, 2016, 4:48 PM - 5:00 PM Central Time |
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Presenter: |
Peter G. Maslak, M.D., Memorial Sloan Kettering Cancer Center |
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Location: |
Arie Crown Theater, McCormick Place, Chicago, IL |
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2016 ASCO Poster Presentation Details: | |
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Title: |
Randomized phase II study of adjuvant WT1 vaccine (SLS-001) for malignant pleural mesothelioma (MPM) after multimodality therapy (Abstract No. 8519) |
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Authors: |
Marjorie Glass Zauderer, Tao Dao, Valerie W. Rusch, Michelle S. Ginsberg, Anne S. Tsao, Katherine Panageas, Angelos M. Stergiou, David A. Scheinberg, Lee M. Krug; Memorial Sloan Kettering Cancer Center, New York, NY; Memorial Sloan Kettering Cancer Center, Molecular Pharmacology and Chemistry Program, New York, NY; The University of Texas MD Anderson Cancer Center, Houston, TX; SELLAS™ Life Sciences Group, New York, NY |
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Session: |
Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers |
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Date & Time: |
Saturday, June 4, 2016 at 8:00 AM – 11:30 AM Central Time |
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Location: |
Hall A, Arie Crown Theater, McCormick Place, Chicago, IL |
"We have seen very promising progress of our WT1 vaccine in diverse cancer indications, and we are pleased that our most advanced clinical findings for this candidate have been featured in leading peer-reviewed forums, including the recent International Conference of the International Mesothelioma Interest Group (iMig) and last November's Annual International WT1 Conference," said Angelos M. Stergiou, M.D., Chairman and Chief Executive Officer of SELLAS™. "We believe that the clinical data we plan to report at next month's ASCO Meeting in acute myeloid leukemia will provide additional key insights into the potential of our therapy to address compelling needs in cancer care and are very excited with the Phase II follow-up survival and immunological response data."
About the Phase 1 and 2 Trials in AML
Phase 1 and Phase 2 trials studied the WT1 analog peptide vaccine in combination with Montanide-adjuvant + GM-CSF in patients with AML who were in first complete response and completed any planned post-remission therapy. Altogether, 31 patients were enrolled in the two studies at Memorial Sloan Kettering Cancer Center. The WT1 vaccine was also provided to the Moffitt Cancer Center for an independent Phase 2 study in AML and myelodysplastic syndrome (MDS) patients (N=10) in second remission (CR2).
About SELLAS™'s WT1 Cancer Vaccine
SELLAS™'s 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™'s 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. 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, 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™ was founded in 2012 and is headquartered in Zug, Switzerland, with additional offices in New York, USA.
Contact:
For Investors:
Ami Bavishi, Burns McClellan, +1 (212) 213-0006, abavishi@burnsmc.com
For Media:
David Moser, J.D., + 1 (813) 864-2571, Dmoser@sellaslife.com
Justin Jackson, Burns McClellan, +1 (212) 213-0006, jjackson@burnsmc.com
SOURCE SELLAS Life Sciences Group