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Jubilant Therapeutics Begins Phase I/II Trial of LSD1/HDAC6 Inhibitor

NEW YORK – Jubilant Therapeutics on Tuesday said the first cancer patient has received their LSD1/HDAC6 inhibitor JB1-802 in a Phase I/II trial.

The Bedminster, New Jersey firm aims to enroll 126 patients with advanced solid tumors into the two-part, open-label, dose expansion and escalation trial. Researchers hope to define the safety, tolerability, and preliminary efficacy of JBI-802 as well as explore predictive biomarkers of response. Once the recommended Phase II dose is established, researchers will enroll patients with small cell lung cancer, neuroendocrine prostate cancer, and other neuroendocrine-derived cancers into expansion cohorts.

JBI-802 is Jubilant's first internally developed product. It is designed to inhibit two epigenetic targets, LSD1 and HDAC6, which in turn interferes with stem cell modulation and immune suppression. Based on promising preclinical antitumor activity and safety profile, Jubilant is developing JBI-802 as a treatment for solid tumors and hematologic cancers.

"We have come a long way from drug discovery to first-in-human dosing," Jubilant Chairman Hari Bhartia said in a statement. "Our expertise in structure-based drug design and medicinal chemistry enables us to create differentiated precision therapeutics with truly innovative properties."

In addition to JBI-802, the company is also developing JBI-778, a brain-penetrant PRMT5 inhibitor, and JBI-2174, a brain-penetrant PD-L1 inhibitor, for neurological and other cancers.