Jubilant Therapeutics Inc., a clinical stage biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced that the FDA has granted Orphan Drug Designation (ODD) for JBI-778 for the treatment of Glioblastoma Multiforme (GBM). JBI-778 is an oral, brain penetrant and substrate-competitive protein arginine methyl transferase 5 (PRMT5) inhibitor for the treatment of tumors with brain metastases and primary brain tumors including high-grade glioma.
JBI-778 is the Company's second drug candidate to receive ODD along with JBI-802, which received ODD for the treatment of small cell lung cancer (SCLC) and acute myeloid leukemia (AML).
"JBI-778 is our highly differentiated, substrate competitive PRMT5 inhibitor in development for both systemic and brain tumors with certain genetic signatures. It is the second clinical stage oral drug candidate that has emerged from the TIBEO discovery engine," said Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. He further added, "JBI-778's differentiated profile compared to other PRMT5 inhibitors in development addresses safety issues of first-generation PRMT5 inhibitors. It also enables a balanced exposure in brain and plasma - for the treatment of GBM and brain metastases along with the systemic disease. We have identified a novel synthetic lethality approach for prospective patient selection in target indications. JBI-778 has already been cleared by the US FDA to initiate clinical trials, which we anticipate to start during the second half of 2023."
The US FDA's Office of Orphan Products Development (OOPD) grants orphan designation status to a drug that is intended to treat a rare disease or condition that affects fewer than 200,000 persons in the United States.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!