ZUG, Switzerland and NEW YORK, Sept. 19, 2016 /PRNewswire/ -- SELLAS™ Life Sciences Group (SELLAS), a development-stage biopharmaceutical company focused on developing innovative products to treat cancer, today announced that the U.S. Food And Drug Administration (FDA) has granted Fast Track Designation for galinpepimut-S for the treatment of Malignant Pleural Mesothelioma (MPM) patients.
The FDA's Fast Track program is an expedited drug development and review program for new drugs or biologics which show promise in treating serious or life-threatening conditions and address an unmet medical need.
Galinpepimut-S, SELLAS' WT1 cancer vaccine, is a late clinical-stage immunotherapy being developed to target hematologic cancers and solid tumors, including MPM, AML, multiple myeloma, ovarian and other cancers. SELLAS plans to commence a pivotal Phase 3 trial in patients with MPM in the second half of 2017.
"This Fast Track designation underscores the importance of galinpepimut-S as a potential treatment option in mesothelioma. We are excited to begin the pivotal Phase 3 trial in patients with MPM in the second half of 2017 and expect the Fast Track designation to expedite the time to market, thereby enhancing the value proposition of galinpepimut-S in this indication," said Dr. Angelos M. Stergiou, M.D., Vice Chairman and Chief Executive Officer of SELLAS.
"SELLAS has made rapid progress against its strategic goals in the past six months, and this milestone follows the FDA's Fast Track designation for AML, and recent orphan drug designations in the US and Europe for galinpepimut-S in both AML and MPM," he added. "Galinpepimut-S is demonstrating its potential as an anti-cancer agent, with outstanding results regarding survival, immunological responses, and safety in AML and MPM patients."
SELLAS's randomized, double-blind, placebo-controlled Phase 2 study in MPM patients enrolled a total of 40 patients at Memorial Sloan Kettering Cancer Center and M.D. Anderson Cancer Center.
According to Phase 2 MPM study data of galinpepimut-S presented at the 2016 International Mesothelioma Interest Group and the 2016 Annual Meeting of the American Society of Clinical Oncology:
The Company also has a clinical study underway for galinpepimut-S in multiple myeloma, and a combination clinical trial with Bristol-Myers Squibb's OPDIVO® (nivolumab) in ovarian cancer.
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 enter pivotal Phase 3 clinical trials in patients with AML and Mesothelioma in the first and second half of 2017, respectively. SELLAS recently received orphan drug designations by the US FDA, as well as the EMA, for galinpepimut-S in AML and MPM; as well as Fast Track Designation for AML and MPM by the US FDA.
Galinpepimut-S also is in various development phases in multiple myeloma, ovarian cancer, and soon in other indications as monotherapy or in combination with other immuno-oncology agents.
SELLAS was founded in 2012 and is headquartered in Zug, Switzerland, with additional offices in New York.
Advertisement
The FDA's Fast Track program is an expedited drug development and review program for new drugs or biologics which show promise in treating serious or life-threatening conditions and address an unmet medical need.
Advertisement
Galinpepimut-S, SELLAS' WT1 cancer vaccine, is a late clinical-stage immunotherapy being developed to target hematologic cancers and solid tumors, including MPM, AML, multiple myeloma, ovarian and other cancers. SELLAS plans to commence a pivotal Phase 3 trial in patients with MPM in the second half of 2017.
"This Fast Track designation underscores the importance of galinpepimut-S as a potential treatment option in mesothelioma. We are excited to begin the pivotal Phase 3 trial in patients with MPM in the second half of 2017 and expect the Fast Track designation to expedite the time to market, thereby enhancing the value proposition of galinpepimut-S in this indication," said Dr. Angelos M. Stergiou, M.D., Vice Chairman and Chief Executive Officer of SELLAS.
"SELLAS has made rapid progress against its strategic goals in the past six months, and this milestone follows the FDA's Fast Track designation for AML, and recent orphan drug designations in the US and Europe for galinpepimut-S in both AML and MPM," he added. "Galinpepimut-S is demonstrating its potential as an anti-cancer agent, with outstanding results regarding survival, immunological responses, and safety in AML and MPM patients."
SELLAS's randomized, double-blind, placebo-controlled Phase 2 study in MPM patients enrolled a total of 40 patients at Memorial Sloan Kettering Cancer Center and M.D. Anderson Cancer Center.
According to Phase 2 MPM study data of galinpepimut-S presented at the 2016 International Mesothelioma Interest Group and the 2016 Annual Meeting of the American Society of Clinical Oncology:
- As of May 2016, median overall survival of 24.8 months was recorded for galinpepimut-S-treated MPM patients, compared to a median 16.6 month overall survival for patients in the control arm.
- Patients with a complete tumor resection and subsequent treatment with galinpepimut-S showed a significant survival benefit
- Galinpepimut-S induced CD8+ and CD4+ T cell activation
- Galinpepimut-S demonstrated a favorable safety and tolerability profile in MPM patients and was well-tolerated by patients in the trial.
The Company also has a clinical study underway for galinpepimut-S in multiple myeloma, and a combination clinical trial with Bristol-Myers Squibb's OPDIVO® (nivolumab) in ovarian cancer.
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 enter pivotal Phase 3 clinical trials in patients with AML and Mesothelioma in the first and second half of 2017, respectively. SELLAS recently received orphan drug designations by the US FDA, as well as the EMA, for galinpepimut-S in AML and MPM; as well as Fast Track Designation for AML and MPM by the US FDA.
Galinpepimut-S also is in various development phases in multiple myeloma, ovarian cancer, and soon in other indications as monotherapy or in combination with other immuno-oncology agents.
SELLAS was founded in 2012 and is headquartered in Zug, Switzerland, with additional offices in New York.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/sellas-life-sciences-receives-fda-fast-track-designation-of-galinpepimut-s-for-the-treatment-of-malignant-pleural-mesothelioma-300329701.html
SOURCE SELLAS Life Sciences Group
