Jubilant Therapeutics announced the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) for the development plan, clinical study design and dosing strategy for the Phase I/II trial of JB1-802, a dual inhibitor of LSD1 and HDAC6. It is for the treatment of small cell lung cancer, treatment-induced neuroendocrine prostate cancer and other mutation-defined neuroendocrine tumours.

A pre-IND meeting provides the drug development sponsor with an opportunity for open communication with the FDA to discuss the IND development plan and to obtain the agency's guidance regarding the planned clinical evaluation of the sponsor's new drug candidate. After reviewing the preclinical data provided, plans for additional data generation and the Phase I/II clinical trial protocol, the FDA addressed Jubilant Therapeutics' questions, provided guidance and aligned with the sponsor on the proposed development plan for JBI-802.

"We appreciate the FDA's guidance as we endeavour to find an innovative new treatment for high unmet-need tumours with devastatingly low survival rates," said Hari S Bhartia, Chairman, Jubilant Therapeutics Inc.

"We are pleased with the outcome of the pre-IND meeting with the FDA and plan to submit the IND application by the end of 2021," said Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc.