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FDA Clears Jubilant Therapeutics' IND Allowing for LSD1/HDAC6 Inhibitor Clinical Trial

NEW YORK – Jubilant Therapeutics on Wednesday said its investigational new drug application for JBI-802 was cleared by the US Food and Drug Administration, allowing the company to proceed with a Phase I/IIa trial of the drug in certain solid tumors.

JBI-802 is a dual inhibitor of LSD1 and HDAC6. In the planned dose escalation and expansion trial, Jubilant will evaluate JBI-802 as a treatment for previously treated, locally advanced or metastatic solid tumors. Expansion cohorts will enroll patients with small cell lung cancer, treatment-induced neuroendocrine prostate cancer, and other mutation-defined neuroendocrine tumors, according to the company.

In preclinical studies, the firm has also identified a molecular signature for predicting response to JBI-802, Jubilant CSO Luca Rastelli said in an emailed comment.

"We have profiled our compound in a large set of tumor cell lines and identified a molecular signature for sensitivity, which we are planning to test in our clinical trial," Rastelli said, though he declined to describe the predictive signature in more detail. "It is important to note that the tumor types that we are focusing on in the trial, SCLC and neuroendocrine prostate [cancer], are already enriched in patients with that signature."

Bedminster, New Jersey-based Jubilant is also exploring JBI-802 as a treatment for hematological cancers, including acute myelogenous leukemia and myelodysplastic syndrome. In 2020, the company presented preclinical research showing JBI-802 had anti-proliferative activity in blood cancers.

Beyond JBI-802, Jubilant's drug development pipeline includes several drugs targeting PRMT5, PD-L1, EGFR, and BRD4 that are in preclinical studies.