On Friday, Jubilant Therapeutics Inc. stated that the first patients in two pipeline programs—the Phase I/II clinical trial of JBI-802 in heme-oncology and the Phase I clinical trial of JBI-778 in solid tumours—had been dosed in international clinical trials.
Hari S. Bhartia, Chairman of Jubilant Therapeutics Inc., stated, “We are thrilled to take this important 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.”
According to a statement from the business, JBI-802 is a first-in-class, oral, small-molecule dual inhibitor of HDAC6 (Histone Deacetylase 6) and LSD1 (Lysine-specific Histone Demethylase 1A) inside the CoREST (Co-repressor of Repressor Element-1 Silencing Transcription) complex.
“JBI-802 demonstrated a dose-proportional increase in exposure across cohorts and a high association between exposure and the on-target impact of platelet reduction in the previous Phase I research carried out in patients with advanced solid tumours. Anaemia and dysgeusia, which are common side effects of LSD1-only inhibitors, were not reported. In patients with non-small cell lung cancer (NSCLC), the Phase I study also demonstrated anti-tumor effectiveness, including a verified partial response. The business claimed in a statement that the study’s overall findings demonstrated human proof-of-principle for extending the development of JBI-802 in Essential Thrombocythemia and Myelodysplastic Syndrome/Myeloproliferative Neoplasms (MDS/MPN) with thrombocytosis.
Over 100,000 people in the US suffer from essential thrombocytopenia, a chronic condition characterised by an overabundance of platelets. Hydroxyurea is the main treatment for this condition, however, it has serious safety and effectiveness issues for patients.
In the second clinical trial, JBI-778, an oral brain-penetrant inhibitor of PRMT5 (Protein arginine N-methyltransferase 5), will be evaluated for safety and the recommended Phase II dose in mEGFR Tyrosine Kinase Inhibitor (TKI) resistant non-small cell lung cancer (NSCLC), IDH+ high-grade glioma (HGG), and adenoid cystic carcinoma (ACC).
The toxicity risks associated with the SAM competitive strategy to PRMT5 inhibition and the patient segment limits of the MTAP null tumor-focused approach to PRMT5 inhibition have led to mixed outcomes in drug development, despite PRMT5 being a validated route for various malignancies. According to the statement, JBI-778 is a novel substrate competitive brain penetrant PRMT5 inhibitor that has demonstrated no negative effects in preclinical settings and may treat brain tumours as well as MTAP null and wild type tumours, serving a wider patient population that includes patients with brain metastases.
Our TIBEO [Therapeutic Index and Brain Exposure Optimisation] Discovery Engine was used internally at Jubilant Therapeutics Inc. to find the two most promising new medication candidates. Our distinct method of structure-based drug creation produces new pharmacophores with a higher therapeutic index than those of current drugs. In genetically defined subgroups of patients with specific haematological and solid tumour indications and significant unmet medical needs, we are thrilled to advance both JBI-802 and JBI-778. Syed Kazmi, CEO of Jubilant Therapeutics Inc., stated that the first clinical results should be read out in 2025.
