On April 26, 2022 Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported the dosing of the first patient in a Phase I/II clinical trial of JBI-802 in patients with advanced solid tumors (Press release, Jubilant Therapeutics, APR 26, 2022, View Source [SID1234612999]). JBI-802 is a first-in-class, small-molecule, orally administered dual inhibitor of LSD1 and HDAC6 that has demonstrated synergistic anti-tumor activity in animal models.
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The Phase I/II trial is an open label, two-part dose escalation and expansion study designed to define the safety and tolerability, explore predictive biomarkers and assess preliminary activity of JBI-802 in more than 100 study participants with advanced solid tumors. More information on the clinical trial can be found at NCT05268666.
Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. shared on the announcement, "We have come a long way from drug discovery to first-in-human dosing. We look forward to making a difference in patients’ lives. Our expertise in structure-based drug design and medicinal chemistry enables us to create differentiated precision therapeutics with truly innovative properties."
Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. said, "JBI-802, effectively modulates two validated oncology targets with similar affinity and quick on/off exposure kinetics, leading to synergistic anti-tumour activity with a reduced risk of thrombocytopenia. This is our first internally developed product candidate to enter clinical development. Other advancing programs include an oral brain penetrant inhibitor of PRMT5, JBI 778, and an oral brain penetrant PDL1 inhibitor, JBI 2174, for neurological cancers among others."
About JBI-802
JBI-802 is novel, oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6. It targets stem cell modulation by inhibiting LSD1 and modulates immune suppression with isoform selective HDAC6 inhibition. Preclinical research has demonstrated its synergistic anti-tumor activity, which is superior vs. either target alone and a favorable safety profile with no significant safety concerns or accumulation. It will be evaluated in both solid tumors, such as small cell lung cancer and neuroendocrine prostate cancer and hematological cancers such as acute myelogenous leukemia, myelodysplastic syndrome, and other myeloproliferative cancers.