STCube Begins US Phase 1 Clinical Trial... "Immune Checkpoint Inhibitor ‘hSTC810’ FDA Clinical Approval"

[Asia Economy Reporter Hyunseok Yoo] STCube, a company developing immune checkpoint inhibitors, is set to officially begin Phase 1 clinical trials in the United States for its new first-in-class innovative drug candidate ‘hSTC810’.

On the 17th, STCube announced that the clinical trial application (IND) for the immune checkpoint inhibitor ‘hSTC810’ was approved by the U.S. Food and Drug Administration (FDA). ‘hSTC810’ is an immune checkpoint inhibitor candidate targeting the immune checkpoint protein ‘BTN1A1’, which STCube discovered for the first time in the world.

An STCube representative stated, “‘hSTC810’ is a new immune checkpoint inhibitor pipeline designed to treat patients who are not adequately addressed by the currently approved representative immune checkpoint therapies PD-1 and PD-L1,” adding, “The ‘hSTC810’ antibody targeting ‘BTN1A1’, an upstream regulator of PD-L1, will play a very important role as a useful treatment for patients who are unresponsive to existing immune checkpoint therapies.”

They continued, “With the FDA’s IND approval, interest from multinational pharmaceutical companies has increased, and if results corresponding to the preclinical data are obtained, not only the possibility of technology transfer but also the scale of it is expected to exceed expectations,” further stating, “We plan to promptly initiate clinical trials after review by the Institutional Review Boards (IRBs) of clinical trial sites in the U.S., including MD Anderson Cancer Center, Yale Cancer Center, and Mount Sinai Hospital.” They also added, “Recruitment of clinical patients will proceed rapidly, targeting patients with unmet needs.”

In Phase 1, the safety, tolerability, pharmacokinetics, and preliminary efficacy of ‘hSTC810’ monotherapy will be evaluated in patients with advanced solid tumors, and the maximum tolerated dose and maximum administered dose will be determined. The dose escalation cohort will include up to 36 patients, and depending on clinical results, additional subjects may be added as a backfill cohort.

Last November, STCube presented research results at the Society for Immunotherapy of Cancer (SITC) showing that ‘BTN1A1’ exhibited a high expression rate in solid tumors, which are refractory diseases with low PD-L1 expression, and that it is expressed mutually exclusively without overlapping with PD-L1, producing a synergistic effect with PD-L1.

Furthermore, through experiments using humanized mice with lung cancer cell line (A549) CDX (cell line-derived xenograft), it was revealed that the tumor growth inhibitory effect of the ‘hSTC810’ antibody targeting ‘BTN1A1’ is superior to that of existing PD-L1 in tumor cells where it is predominantly expressed.

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