News
Jubilant Therapeutics receives Orphan Drug Designation for PRMT5 inhibitor - JBI-778
IMT News Desk
1 year ago
Jubilant Therapeutics receives Orphan Drug Designation for PRMT5 inhibitor – JBI-778
IMT News Desk
1 year ago
The drug is used for the treatment of Glioblastoma Multiforme
Jubilant Therapeutics, a clinical-stage biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, announced that the United States Food and Drug Administration (US 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 tumours with brain metastases and primary brain tumours 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 leukaemia (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. 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 the brain and plasma - for the treatment of GBM and brain metastases along with 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 US.
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