By this time next year, a pivotal Phase 3 trial will be underway on what looks to be one of the most promising new therapies for malignant pleural mesothelioma.
The makers of galinpepimut-S, an immunotherapy vaccine with Orphan Drug status for acute myeloid leukemia and pleural mesothelioma, recently announced their intention to begin the Phase 3 mesothelioma trial in mid-2017.
The news was punctuated by the FDA’s decision to “fast track” development and review of galinpepimut-S for mesothelioma. It had already been granted Fast Track status for acute myeloid leukemia.
“This Fast Track designation underscores the importance of galinpepimut-S as a potential treatment option in mesothelioma,” the company’s CEO, Angelos Sterigou, MD, said in a statement. Dr. Sterigou says the Fast Track designation is expected to speed the time it takes to put galinpepimut-S on the market, meaning it could begin impacting mesothelioma survival sooner.
What is Galinpepimut-S?
Galinpepimut-S is an immunotherapy drug developed by scientists at Memorial Sloan Kettering Cancer Center and licensed to a biopharmaceutical company called SELLAS Life Sciences.
It is being developed specifically to target blood cancers and solid tumors including malignant pleural mesothelioma, acute myeloid leukemia, multiple myeloma, ovarian and other cancers.
According to a Phase 2 study that included 40 malignant pleural mesothelioma patients at Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, patients on galinpepimut-S lived for a median of more than 2 years while those in the control group had a median survival of just 16.6 months.
Patients who had had mesothelioma surgery followed by treatment with galinpepimut-S showed the greatest survival benefit.
How Does It Work to Fight Mesothelioma?
Like other immunotherapy drugs for mesothelioma, galinpepimut-S works by activating the patient’s own immune system to help fight their cancer. Galinpepimut-S specifically targets WT-1 or the Wilms Tumor protein found on the surface of mesothelioma cells.
Pleural mesothelioma cells, like other cancer cells, have ways of “hiding” from the immune system, allowing them to grow and spread unchecked.
Immunotherapy drugs like galinpepimut-S help make cancer cells visible again and stimulate the activation of cancer-fighting immune system T-cells including CD8+ and CD4+.
A Phase 3 drug trial is a clinical study intended to provide the evidence needed for the FDA to issue its final stamp of approval to market the drug. Galinpepmut-S already has the FDA’s Orphan Drug designation, a designation aimed an encouraging the development of drugs for rare medical conditions like malignant mesothelioma.
“SELLAS Life Sciences Receives FDA Fast Track Designation of Glainpepimut-S for the Treatment of Malignant Pleural Mesothelioma”, September 19, 2016, News Release, SELLAS website