Jubilant Therapeutics Inc., a US-based biopharmaceutical company, announced on Friday that it has completed a pre-Investigational New Drug (IND) meetings with the US Food and Drug Administration (FDA) regarding the development plan, clinical trial design, and dosing strategy for the Phase I / II trial of JB1-802, a dual inhibitor of LSD1 and HDAC6, for the treatment of small cell lung cancer (SCLC), treatment-induced neuroendocrine prostate cancer, and other mutation-defined neuroendocrine tumours.

A pre-IND meeting provides the firm with an opportunity to openly communicate with the US FDA, discuss the development plan for the IND, and receive advice from the agency on the new drug candidate's planned clinical trial.

The FDA responded to the company's questions, offered guidance, and approved the proposed development plan for the product, after reviewing the pre-clinical data submitted, the plans to generate additional data, and the protocol of the Phase I / II clinical trial.