Jubilant Therapeutics Announces First Patient Dosing in Global Clinical Trials for JBI-802 And JBI-778

Overview

Jubilant Therapeutics Inc., has 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 tumours.

 Words from the Chairman: Jubilant Therapeutics Inc.

We are excited to take this significant step forward in our mission to transform the lives of patients through the development of easy to administer precision oral medicines with enhanced safety and therapeutic efficacy,” said Hari S Bhartia, chairman, Jubilant Therapeutics Inc.

About JBI-802

• JBI-802 is a first-in-class, orally administered, small-molecule dual inhibitor of LSD1 (Lysine-specific histone demethylase 1A) and HDAC6 (Histone deacetylase 6) within the CoREST (Co-repressor of Repressor Element-1 Silencing Transcription) complex. 
• In the earlier phase I study conducted in advanced solid tumour patients, JBI-802 showed a dose-proportional increase in exposure across cohorts and a strong correlation between exposure and the on-target effect of platelet decrease. 
• There were no reports of dysgeusia and anaemia, typical adverse events seen with LSD1only inhibitors. 
• The phase I trial also showed anti-tumour activity in non-small cell lung cancer (NSCLC) patients including a confirmed partial response. 
• Overall, the study results provided human proof-of-principle for expanding the development of JBI-802 in essential thrombocythemia and myelodysplastic syndrome/myeloproliferative neoplasms (MDS/MPN) with thrombocytosis.

Essential Thrombocythemia

Essential thrombocythemia is a chronic disease of excessive platelets with over 100,000 patients in the United States for whom the primary treatment is hydroxyurea, a therapy that poses sever limitations for patients in terms of both safety and efficacy.

About 2nd Trial

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).

About PRMT5

• PRMT5, although a proven pathway for multiple cancers, has produced mixed results in terms of drug development due to safety concerns surrounding SAM competitive approach to PRMT5 inhibition and patient segment limitations of MTAP null tumour-focused approach PRMT5 inhibition. 
• JBI-778 is a unique substrate competitive brain penetrant PRMT5 inhibitor that has shown no adverse effects in preclinical setting and can address both MTAP null and wild type tumours as well as brain tumours, catering to larger patient segment including those with brain metastases.

From Jubilant Therapeutics Inc.

• The two most advanced novel drug candidates at Jubilant Therapeutics Inc. were discovered in-house using our TIBEO [Therapeutic Index and Brain Exposure Optimization] Discovery Engine. It is our unique approach of structure-based drug design to generate novel pharmacophores with improved therapeutic index compared to existing agents.
• We are excited to advance both JBI-802 and JBI-778 in genetically-defined subsets of patients with select haematological and solid tumour indications with high unmet medical needs. Initial clinical data are expected to read out in 2025,” said Syed Kazmi, chief executive officer, Jubilant Therapeutics Inc.

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