Jubilant Therapeutics Begins Global Trials for JBI-802 and JBI-778

Jubilant Therapeutics Inc., a biopharmaceutical company dedicated to advancing precision therapeutics for oncology and autoimmune diseases, has announced the initiation of global clinical trials for two of its promising pipeline programs. The trials involve a Phase I/II study of JBI-802, targeting hematological malignancies, and a Phase I study of JBI-778, aimed at solid tumors.

JBI-802, an innovative, orally administered molecule, acts as a dual inhibitor of LSD1 and HDAC6 within the CoREST complex. In prior Phase I studies among patients with advanced solid tumors, JBI-802 demonstrated a dose-dependent increase in exposure and a significant correlation with the intended effect of platelet reduction. The treatment was noted for not causing common side effects like Dysgeusia and Anemia, typically associated with LSD1-only inhibitors. Additionally, it exhibited anti-tumor activity in Non-Small Cell Lung Cancer (NSCLC) patients, including confirmed partial responses. These results have paved the way for further exploration of JBI-802 in treating conditions such as Essential Thrombocythemia and Myelodysplastic Syndrome/Myeloproliferative Neoplasms (MDS/MPN) with thrombocytosis.

Essential Thrombocythemia, a chronic disorder characterized by excessive platelet production, affects over 100,000 individuals in the United States. The current primary treatment, hydroxyurea, has notable limitations regarding safety and efficacy.

The second trial focuses on JBI-778, an oral PRMT5 inhibitor that penetrates the brain. This trial aims to determine the safety and recommended Phase II dosage for patients with mEGFR Tyrosine Kinase Inhibitor (TKI) resistant NSCLC, IDH+ high-grade glioma (HGG), and Adenoid Cystic Carcinoma (ACC). PRMT5 is a known pathway involved in various cancers, but previous drug development efforts have faced challenges due to safety concerns and the limitations of patient segments. JBI-778, however, is a substrate-competitive inhibitor that has shown no adverse effects in preclinical settings. It is designed to address both MTAP null and wild-type tumors, as well as brain tumors, thus potentially benefitting a larger patient population, including those with brain metastases.

The development of these two drug candidates was led by Jubilant Therapeutics' in-house TIBEO (Therapeutic Index and Brain Exposure Optimization) Discovery Engine, which focuses on structure-based drug design to create novel pharmacophores with improved therapeutic indices. This approach aims to generate more effective treatments compared to existing options. The company anticipates initial clinical data from these trials to be available in 2025.

JBI-802 is recognized as a novel, potent, and selective dual inhibitor targeting the CoREST complex's epigenetic markers, LSD1 and HDAC6. Its preclinical studies have shown it to be effective against various hematological cancers, as well as solid tumors like NSCLC and small cell lung cancer, with a favorable safety profile.

JBI-778 is another innovative drug, designed as a potent, brain-penetrant inhibitor of PRMT5. It targets the substrate site and stabilizes SAM bound to PRMT5, ensuring high biological selectivity and demonstrating a superior safety profile in preclinical studies. The drug has shown promising results in Tyrokinase-Inhibitor resistant cell lines, brain tumors, and NSCLC.

Jubilant Therapeutics Inc. is headquartered in Morrisville, North Carolina, and focuses on developing oral medicines with enhanced therapeutic indices to meet unmet medical needs in oncology and autoimmune diseases for genetically defined patients. Their structure-based discovery engine, TIBEO, has been validated through successful collaborations, and the clinical pipeline includes advanced candidates like JBI-802 and JBI-778. The company continues to work on additional pre-clinical programs targeting oncology and inflammatory indications.