STCube, Successful Global Phase 1 Clinical Trial of Nelmastovat

Challenge of Innovative Immuno-Oncology Drugs
Strategic Partnerships Including Technology Export
Targeting Unmet Demand Market for Immune Checkpoint Inhibitors

[Asia Economy Reporter Hyungsoo Park] STCube, a developer of immune checkpoint inhibitors, announced on the 2nd that it has completed the global Phase 1 clinical trial of its innovative immune checkpoint inhibitor drug 'Nelmastobat (hSTC810).' The safety evaluation, a key endpoint of the Phase 1 trial, has been completed, demonstrating safety.

The global Phase 1 trial of Nelmastobat confirmed safety through a 6-step dose escalation. Above all, it was designed to determine the appropriate dose by confirming additional safety and efficacy through a backfill cohort.

The dose escalation consisted of six steps: 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 10 mg/kg, and 15 mg/kg. Safety was confirmed even at the highest dose of 15 mg/kg. Only the procedure to confirm efficacy in additional patients and determine the optimal dose remains.

New efficacy was observed in patients with refractory solid tumors who relapsed after standard treatment and had no suitable treatment options. Based on clinical data, STCube is discussing concrete commercialization plans with potential partners.

Jung Hyunjin, CEO of STCube, said, "We have confirmed the potential and competitiveness of an innovative treatment that can benefit the majority of cancer patients who do not receive the benefits of immune checkpoint inhibitors," adding, "The effect has been well maintained so far."

He continued, "The efficacy observed in refractory cancer patients is an encouraging result," and added, "Discussions on strategic partnerships have become more concrete following the JP Morgan Healthcare Conference."