Jubilant Therapeutics Inc., a clinical stage biopharmaceutical company dedicated to providing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, is proud to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for JBI-778 for the treatment of Glioblastoma Multiforme (GBM). JBI-778 is an exciting and innovative oral, brain-penetrant, and substrate-competitive inhibitor of protein arginine methyl transferase 5 (PRMT5), designed to target tumors with brain metastases and primary brain tumors such as high-grade glioma. With this designation, Jubilant Therapeutics is closer to bringing this potentially life-saving treatment to those who need it.
JBI-778 has become the Company’s second drug candidate to be granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA). This news follows the FDA’s granting of ODD to JBI-802, which is being developed to treat small cell lung cancer (SCLC) and acute myeloid leukemia (AML). These groundbreaking designations represent a major milestone in the Company’s mission to bring new and innovative treatments to those suffering from serious and life-threatening diseases.
Jubilant Therapeutics Inc. is proud to announce the development of JBI-778, a highly differentiated and substrate competitive PRMT5 inhibitor, for both systemic and brain tumors with certain genetic signatures. This oral drug candidate is the second to emerge from the TIBEO discovery engine, and its unique profile offers a safe and balanced exposure for the treatment of GBM and brain metastases along with systemic disease. Furthermore, a novel synthetic lethality approach has been identified for prospective patient selection in target indications. The US FDA has already cleared JBI-778 for clinical trials, slated to begin in the second half of 2023. We are excited to offer this innovative drug to those who need it most.
The US FDA’s Office of Orphan Products Development (OOPD) offers a special status to drugs intended to treat rare diseases or conditions that affect fewer than 200,000 people in the United States – the coveted orphan designation. By achieving this status, the drug’s creator can receive special incentives and assistance to bring the drug to market and change the lives of those affected by the rare disease.
About JBI-778
JBI-778 is an innovative and potent inhibitor of protein arginine methyl transferase 5 (PRMT5) that has the potential to revolutionize the treatment of advanced cancers and high-grade glioma that have limited treatment options. Its unique mechanism of action, which is both substrate-competitive and S-adenosylmethionine (SAM) cooperative, allows for targeted treatment of primary brain tumors and CNS metastasis with an enhanced therapeutic index. Moreover, JBI-778’s high brain exposure and lack of interference with SAM functions suggest an excellent tolerability profile, making it a promising option for those in need.
About Jubilant Therapeutics Inc.
Jubilant Therapeutics Inc. is a revolutionary biopharmaceutical company that is revolutionizing the way we treat oncology and autoimmune diseases. With its advanced TIBEO (Therapeutic Index and Brain Exposure Optimization) discovery engine, the company has been able to develop precision oral medicines with a unique enhanced therapeutic index for genetically defined patients. Already, it has entered into successful partnerships with Blueprint Medicines for a groundbreaking brain penetrant EGFR Exon-20 program. The company’s pipeline is also impressive, consisting of a first in class dual coREST modifier, JBI-802, which is currently in a Phase I/II clinical trial, a novel brain-penetrant modulator of PRMT5, brain penetrant and gut restrictive PDL1 inhibitors, as well as PAD4 inhibitors for oncology and inflammatory indications. All of this is overseen by globally renowned scientific advisors and is based in Bedminster, New Jersey.