STCube Completes FDA Pre-Meeting for Innovative New Drug Candidate

[Asia Economy Reporter Hyungsoo Park] STCube, an immuno-oncology research and development company, is accelerating its efforts to advance global clinical trials for an innovative new drug candidate developed for the first time in the world.

STCube announced on the 30th that it held a Pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) ahead of submitting the global Phase 1 clinical trial plan for its innovative new drug candidate ‘hSTC810’.

A company official explained, "On the 29th, a meeting involving the company’s key executives and core researchers was held, during which discussions on the overall clinical plan, including preclinical trial results and clinical design for ‘hSTC810’, were completed."

The Pre-IND meeting is a procedure to discuss the overall new drug development and clinical plans and represents the first step toward full-scale clinical advancement. It involves reviewing and coordinating with the FDA on the new drug development status, appropriateness of the clinical plan, and whether sufficient data is available for human clinical trials, covering all aspects related to the clinical trials of the new drug candidate.

Through this Pre-IND meeting, STCube reviewed ▲CMC (Chemistry, Manufacturing and Control) issues such as the stability and impurities of the new drug candidate ▲the suitability of the conducted nonclinical data ▲and the Phase 1 clinical trial plan. STCube plans to submit the IND within this year, complete clinical approval, and begin dosing the first patient next year.

A company official emphasized, "There appears to be no issues in proceeding with the remaining clinical preparation schedule," adding, "We expect the value of hSTC810 to be recognized and are simultaneously pursuing technology transfer with global pharmaceutical companies."

STCube will additionally present research results on the immune checkpoint protein ‘BTN1A1’, which is under global clinical development, at the American Association for Cancer Research-European Union Cancer Congress (AACR-NCI-EORTC) held online from the 7th to the 10th of next month.

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