STCube Receives IND Approval for Colorectal Cancer Phase 1b/2 Trial... Biomarker-Based Clinical Study Begins

STCube announced on the 21st that it has received approval from the Ministry of Food and Drug Safety for the clinical trial application (IND) of the anti-BTN1A1-based immune checkpoint inhibitor ‘Nelmastovat’ for metastatic colorectal cancer Phase 1b/2.

Nelmastovat is the first-in-class immune checkpoint inhibitor targeting BTN1A1, which is mutually exclusively expressed with PD-L1, a representative anticancer target of existing immune checkpoint inhibitors. It is attracting attention as a new treatment option for patients who do not respond to or have developed resistance to existing therapies.

An STCube official stated, "The IND approval was granted faster than expected," adding, "We systematically and meticulously designed the clinical trial in accordance with regulatory agency guidelines." He continued, "Since we have prepared thoroughly over a long period, we will do our best to ensure that patient recruitment and dosing procedures proceed smoothly and swiftly."

The clinical trial will be conducted at five university hospitals in Korea. STCube is currently undergoing review by the Institutional Review Board (IRB) of Korea University Anam Hospital and will promptly apply for IRB review at the remaining hospitals to proceed with the trial.

This study evaluates the efficacy and safety of Nelmastovat in combination with the global standard treatments TAS-102 and bevacizumab in metastatic/recurrent colorectal cancer patients who are refractory or intolerant to oxaliplatin- and irinotecan-based chemotherapy. STCube submitted the IND to the Ministry of Food and Drug Safety last month.

The trial is distinguished from previous studies as a biomarker-based clinical trial targeting BTN1A1-positive patients. Based on the correlation between BTN1A1 expression and drug responsiveness identified in prior research, the study adopts a strategy to maximize the therapeutic efficacy of Nelmastovat, which is highly significant.

In Phase 1b (minimum 6 patients), the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of the combination therapy will be determined, with dose-limiting toxicity (DLT) evaluation completed within the first half of this year. In the subsequent Phase 2 (minimum 52 patients), efficacy will be assessed by setting progression-free survival (PFS) as the primary endpoint in patients with a BTN1A1 tumor proportion score (TPS) of 50% or higher.

STCube aims to demonstrate the clinical value of BTN1A1-based immuno-oncology drugs as an innovative treatment option that overcomes the therapeutic limitations of existing immune checkpoint inhibitors through this clinical trial. Patients with BTN1A1 TPS of 50% or higher account for more than 30% of all colorectal cancer patients and show high expression rates in various solid tumors, including lung cancer.

Jung Hyunjin, CEO of STCube, said, "This will be an important opportunity to prove the new immune-oncology target and biomarker BTN1A1 and the novel drug value of Nelmastovat," adding, "Since the pharmacological characteristics of Nelmastovat have been validated through previous studies, we expect the IRB process to proceed swiftly as well."