STCube Advances US Clinical Trial of Immune Checkpoint Inhibitor Antibody 'STT-003'

[Asia Economy Reporter Hyunseok Yoo] STCube, a bio company developing immune checkpoint inhibitors, announced on the 24th that it has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for the STT-003 antibody, co-developed with the MD Anderson Cancer Center (hereinafter MDACC), and plans to initiate clinical trials next year.

A company representative stated, “We have started production of the STT-003 antibody therapeutic through contract development and manufacturing agreements with global Contract Development and Manufacturing Organizations (CDMOs),” and added, “We are currently preparing all necessary steps to begin clinical research next year in collaboration with MDACC and other leading U.S. medical institutions.”

STT-003, an immune checkpoint molecule discovered by STCube, shows limited expression in normal tissue cells but exhibits a higher expression rate in various cancer cells compared to PD-L1. Additionally, STT-003 is expressed in immune cells such as T lymphocytes at levels comparable to PD-1, confirming it as a critical immune regulatory molecule that comprehensively suppresses anticancer immune functions in cancer patients.

The company representative further explained, “Experts from the U.S. medical, academic, and industrial sectors also expect the STT-003 antibody to become a first-in-class innovative drug that surpasses the limitations of existing immune checkpoint inhibitors like PD-1 and PD-L1 antibody therapies,” and noted, “Recently, academic exchanges and clinical research discussions regarding STT-003 have been progressing more actively.”

They emphasized, “Given the high potential for success of the STT-003 antibody as a new immune checkpoint inhibitor drug candidate, discussions on joint development and licensing agreements with numerous global pharmaceutical companies are expected to accelerate.”

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