Date: 2016-04-01
Type of information: Presentation of results at a congress
phase: 1-2
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: SELLAS Life Sciences (Switzerland)
Product: galinpepimut-S (human Wilms tumor protein 1 peptides - WT1 vaccine)
Action
mechanism: peptide/vaccine. This vaccine is comprised of four modified peptide chains that induce a strong adaptive T-cell 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. The WT1 vaccine has been originally developed by Memorial Sloan Kettering Cancer Center and licensed to Sellas.
Disease: acute myeloid leukemia
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On April 1, 2016, SELLAS Life Sciences Group announced that results from a Phase 2 trial of the Company’s WT1 cancer vaccine in patients with acute myeloid leukemia have been selected for an oral presentation during the Annual Meeting of the American Society of Clinical Oncology (ASCO), being held in Chicago, IL, June 3-7, 2016. WT1 vaccine (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. Based on the results of its mid-stage clinical program, SELLAS is preparing to initiate a pivotal Phase 3 trial of its WT1 vaccine in acute myeloid leukemia patients by the second quarter of 2016 and a pivotal Phase 2b/3 trial in patients with MPM by the third quarter of this year. 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 MDS patients (N=10) in second remission (CR2). * On October 12, 2015, SELLAS Life Sciences Group announced top-line data from the Company’s Phase 2 clinical study of its WT1 cancer vaccine in patients with malignant pleural mesothelioma (MPM). The study showed clinically meaningful greater median overall survival (OS) in patients receiving the WT1 cancer vaccine: 39 months OS versus 18 months OS for patients in the control arm. Typical median overall survival in patients with MPM receiving currently available treatment options ranges from 15-18 months. In addition, the WT1 cancer vaccine resulted in a median progression-free survival (PFS) of 11.5 months, more than double that of the control arm (5.5 months). The investigators continue to track patient outcomes. As the study was unblinded sooner than expected due to the discontinuation of the control arm for futility, there was a smaller patient cohort and shorter follow-up than originally planned. During the trial, the WT1 vaccine was shown to have a favorable safety and tolerability profile. These and other top-line clinical results from the ongoing WT1 Phase 2 trials will be presented by David A. Scheinberg, M.D., Ph.D., in Kyoto, Japan, at the upcoming 8th International WT1 Conference on November 19-20, 2015. Dr. Scheinberg is Chairman of MSK’s Pharmacology program and the Center for Experimental Therapeutics; and he is an inventor of the WT1 vaccine. In addition, earlier this month Dr. Scheinberg presented the results of a recently closed Phase 2 study of the WT1 vaccine in 22 adults with Acute Myeloid Leukemia (AML) at the 17th Annual International Congress on Chronic Myeloid Leukemia in Lisbon, Portugal. Peter Maslak, M.D., conducted the trial at MSK. Median OS was not reached at more than 50 months.
