ZUG, Switzerland, and NEW YORK, June 6, 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 promising results from a Phase 2 trial of galinpepimut-S, the Company's WT1 cancer vaccine, in patients with acute myeloid leukemia (AML) were presented in an oral presentation at the Annual Meeting of the American Society of Clinical Oncology (ASCO), being held in Chicago, IL, June 3-7, 2016. In addition, a poster was presented at the ASCO meeting detailing positive Phase 2 results of galinpepimut-S for the treatment of patients with malignant pleural mesothelioma (MPM). Further, SELLAS™ announced today that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for galinpepimut-S for the treatment of AML patients. The FDA's Fast Track program is an expedited drug development and review program for new drugs or biologics intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical need.
Galinpepimut-S 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 reported at the ASCO meeting, SELLAS™ plans to commence a pivotal Phase 3 trial of galinpepimut-S in AML patients, as well as a pivotal Phase 2b/3 trial in patients with MPM, later this year.
Key findings for galinpepimut-S presented at the ASCO meeting include the following:
Phase 2 trial in AML patients:
- Galinpepimut-S improved overall and progression-free survival in patients with AML in first complete remission (CR1) in comparison to historical data.
- According to the Phase 2 trial results, administration of galinpepimut-S resulted in a median overall survival of 62.5 months in AML patients, which represents a substantial improvement compared to best standard therapies.
- Galinpepimut-S also resulted in an improved median progression-free survival in AML patients of 23.75 months.
- Serial vaccination with galinpepimut-S showed a favorable safety and tolerability profile in this patient population, whose median age was 63 years old.
- Galinpepimut-S elicited immune responses in patients, including CD4+ and CD8+ T cell responses. There was a trend in improved clinical outcomes in patients who mounted an immune response with galinpepimut-S compared to those patients who did not.
Phase 2 trial in MPM patients
- The trial showed a median overall survival of 24.8 months for galinpepimut-S-treated MPM patients versus a median 16.6 month overall survival for patients in the control arm after the most recent patient follow-up as of May 2016.
- Patients with a complete tumor resection and subsequent treatment with galinpepimut-S showed a significant survival benefit.
- Galinpepimut-S demonstrated a favorable safety and tolerability profile in MPM patients and was well-tolerated by patients in the trial.
Peter Maslak, M.D., Principal Investigator of the AML Phase 2 trial and Chief of the Immunology Laboratory Service, Memorial Sloan Kettering Cancer Center (MSK), as well as presenter of the galinpepimut-S results in AML patients at the ASCO meeting, commented, "We are pleased to report updated positive results for the WT1 vaccine in AML, demonstrating that the vaccine is well-tolerated and associated with prolonged survival in patients in first complete remission. In addition, key results show the impact of T cell responses on patient outcomes. We look forward to the continued progress of the program, including the start of the pivotal Phase 3 study later this year."
Andres Gutierrez, M.D., Ph.D., SELLAS's Chief Medical Officer, stated, "Galinpepimut-S holds promise across broad applications in oncology, and the ASCO meeting has been a perfect and timely opportunity to present updated Phase 2 data in AML and MPM, which provide the basis for design of the first two registration studies that SELLAS plans to start toward the end of this year. The encouraging survival benefit and favorable tolerability found with galinpepimut-S in AML and MPM have also attracted the interest of worldwide experts with whom, amongst others, we have closely collaborated in the development of the clinical studies. ASCO is an ideal conference to meet with thought leaders and clinicians as we prepare for commencement of our pivotal programs this year, as well as other studies in both liquid and solid tumors."
"Galinpepimut-S has continued to demonstrate outstanding results and updated findings in regard to survival, immunological responses, and safety in AML and MPM, as announced at ASCO, and we are now very pleased to report the FDA's Fast Track designation in AML, following the recent orphan drug designations in the US and Europe for galinpepimut-S in both AML and MPM," said Dr. Angelos M. Stergiou, M.D., Chairman and Chief Executive Officer of SELLAS™. "SELLAS is proud of the stellar clinical work by our collaborators at MSK, a leading institution in immuno-oncology and the development of innovative cancer treatments. Our medical and regulatory teams have developed a rigorous and well-designed development program for our lead indications, AML and MPM, based on the very promising Phase 2 clinical trial results. We also have a clinical study underway in multiple myeloma, as well as a combination clinical trial with Bristol-Myers Squibb's OPDIVO in ovarian cancer, and we will be initiating further studies in patients this year. On behalf of SELLAS's Board and shareholders, I wholeheartedly thank patients for their participation in the clinical studies, as well as the diligent work put forth by the research teams at MSK, MD Anderson Cancer Center, and Moffitt Cancer, as well as the entire SELLAS team. We are thrilled to further advance this promising anti-cancer agent in pivotal studies. This is truly an exciting time for SELLAS."
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 MSK. 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 the Phase 2 Trial in Mesothelioma
The double-blind, randomized (1:1) study compared the WT1 analog peptides vaccine in combination with Montanide-adjuvant + Granulocyte-macrophage colony-stimulating factor (GM-CSF), versus Montanide-adjuvant + GM-CSF in patients with MPM who had previously completed combined modality therapy. Thirty-nine patients were to be enrolled in each arm at two centers, MSK and M.D. Anderson Cancer Center. However, in May 2015, the trial's independent Data Monitoring Committee requested discontinuation of the control arm due to futility while leaving open the WT1 cancer vaccine arm. This change led to unblinding the study earlier than planned; total enrollment has reached 40 patients, with 19 patients in the WT1 cancer vaccine arm and 21 in the control arm.
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 MSK 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, particularly its lead product candidate, galinpepimut-S. Galinpepimut-S is a cancer immunotherapeutic agent licensed from Memorial Sloan Kettering Cancer Center that targets a broad spectrum of hematologic cancers and solid tumor indications. Galinpepimut-S is poised to advance into pivotal Phase 2b and 3 trials in acute myeloid leukemia (AML) and malignant pleural mesothelioma (MPM) in the US and Europe in late 2016. SELLAS™ recently received orphan drug designations by the US FDA, as well as the European EMA, for galinpepimut-S in AML and MPM, as well as Fast Track Designation for AML by the US FDA.
Galinpepimut-S also is in various development phases in ovarian cancer, glioblastoma multiforme, and other indications as monotherapy 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.
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SOURCE SELLAS Life Sciences Group