JBI-778 / Jubilant Pharmova - LARVOL DELTA

First in Human Multicenter Open Name Dose-increase, Consolidation Method to Study Safety Drug-level in Blood & Drug Metabolism Clinical Activity of Oral JBI-778 in Lung Cancer Patients With, Without Brain Metastasis IDH Mutated WHO Grade 3,4 Recurrent Glioma, Salivary Glands Tumor (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Jubilant Therapeutics India Limited

First-in-human • New P1 trial • Adenoid Cystic Carcinoma • Brain Cancer • Glioma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Salivary Gland Cancer • Solid Tumor

Phase 1/2 Study Evaluating the Safety, PK/PD, and Clinical Activity of Oral JBI-778 in Patients With Brain Metastases, Leptomeningeal Disease, or Recurrent High Grade Glioma (clinicaltrials.gov) - P1/2 | N=113 | Not yet recruiting | Sponsor: Jubilant Therapeutics Inc.

New P1/2 trial • Brain Cancer • Breast Cancer • Glioblastoma • Glioma • High Grade Glioma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Jubilant Therapeutics Inc. announces First Patient Dosing in Global Clinical Trials for JBI-802, a CoREST Inhibitor and JBI-778, a PRMT5 Inhibitor (PRNewswire) - "Jubilant Therapeutics Inc...announced the dosing of first patients in global clinical trials involving two pipeline programs: Phase I/II clinical trial of JBI-802 in heme-oncology and Phase I clinical trial for JBI-778 in solid tumors....The second clinical trial is to assess both safety and the recommended Phase II dose for JBI-778, an oral brain-penetrant inhibitor of PRMT5 (Protein arginine N-methyltransferase 5) in mEGFR Tyrosine Kinase Inhibitor (TKI) resistant NSCLC, IDH+ high-grade glioma (HGG) and Adenoid Cystic Carcinoma (ACC)."

Trial status • Adenoid Cystic Carcinoma • Essential Thrombocythemia • Glioma • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Non Small Cell Lung Cancer

JBI-778, a novel brain-penetrant small molecule PRMT5 inhibitor for treatment of cancer (AACR 2023) - "PRMT5 inhibitor JBI-778 is able to penetrate the brain in all animal species tested and it is highly efficacious in orthotopic glioma models. Its differentiated mechanism makes it a potential option for the treatment of gliomas and brain metastasis with a focus on patients with spliceosome mutations. IND application for JBI-778 has been approved by FDA and a FIH trial is being planned."

Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Lung Cancer • Medulloblastoma • Neuroblastoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Solid Tumor • POLD1 • PRMT5 • RBM10

Jubilant Therapeutics Inc. receives Orphan Drug Designation for the PRMT5 inhibitor - JBI-778 for the treatment of Glioblastoma Multiforme (GBM) (PRNewswire) - "Jubilant Therapeutics...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 tumors with brain metastases and primary brain tumors including high-grade glioma....'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'."

New trial • Orphan drug • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

"Select projects targeting synthetic lethality TNG908 MRTX1719 SKL27969 AMG 193 AG-270 IDE397 JNJ-64619178 PRT543 PRT811 RP-6306 GSK3326595 GSK3368715 PF-06939999 JBI-778 TNG462 ISM020 AGX323 AT101/ AT201 @JacobPlieth @evaluatepharma https://t.co/74gBPzNLcn https://t.co/5Um0uV9GAB" (,@BRAINCURES)

Synthetic lethality

Jubilant Therapeutics Inc. announces US FDA clearance of IND for JBI-778, an Oral, Brain Penetrant and Selective PRMT5 Inhibitor, for treatment of solid tumors with brain metastases and primary brain tumors (PRNewswire) - "Jubilant Therapeutics Inc...announced U.S. Food and Drug Administration (US FDA) clearance of the Investigational New Drug application (IND) for JBI-778, an oral, brain penetrant and selective protein arginine methyl transferase 5 (PRMT5) inhibitor, for the treatment of solid tumors with brain metastases and primary brain tumors including high-grade glioma....The Phase I/II trial is an open-label, two-part dose escalation and expansion study designed to define the safety profile, pharmacokinetics, optimal dosing and preliminary activity of JBI-778."

IND • New P1/2 trial • Brain Cancer • Glioma • Oncology • Solid Tumor

Jubilant Therapeutics Presents Preclinical Data on its Brain Penetrant PRMT5 Inhibitor and Small Molecule PD-L1 Inhibitor at the American Association for Cancer Research (AACR) Annual Meeting 2021 (PRNewswire) - "Key highlights from an evaluation which examined the tumor growth inhibition of PRMT5 inhibitor JBI-778 in multiple cancer cell lines as well as glioblastoma, include the following:...This oral small molecule demonstrated anti-tumor efficacy in a Mantle Cell lymphoma model with an ED50 of < 10 mg/Kg and a complete tumor growth inhibition (97%) at a dose of 50mg/kg; Key highlights from the PD-L1/PD-1 study which examined the ability of JBI-1527 to inhibit PD-L1 and restore T-cell proliferation and function, include the following:...The inhibitor shows similar modulation of cytokines as Pembrolizumab in BioMAP assay and competes with anti-PD-L1 blocking antibody suggesting similar binding site on PD-L1"

Preclinical • Glioblastoma • Oncology