STCube Applies for IND for Innovative New Drug ‘hSTC810’ Phase 1 Clinical Trial with US FDA

[Asia Economy Reporter Hyunseok Yoo] STCube, a bio company developing immune checkpoint inhibitors, announced on the 20th that it has submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for clinical phase 1 approval of its first-in-class innovative drug ‘hSTC810’.

‘hSTC810,’ for which the IND was submitted to the FDA, is an immune checkpoint inhibitor targeting the ‘BTN1A1’ protein, which STCube discovered for the first time in the world. In this phase 1 clinical trial, STCube will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ‘hSTC810’ monotherapy in patients with advanced solid tumors. STCube had previously applied for IND approval from the Ministry of Food and Drug Safety in Korea on the 6th for the domestic phase 1 trial.

Through the clinical trial, STCube will assess the tolerability and safety of ‘hSTC810’ monotherapy and determine the maximum tolerated dose and maximum administered dose. The dose-escalation cohort will include up to 36 patients, and depending on the clinical results, the number of trial subjects may be further increased with a backfill cohort.

The clinical trials conducted in the U.S. will take place at three world-leading cancer research institutions: MD Anderson Cancer Center, Yale Cancer Center, and Mount Sinai Hospital.

A company representative stated, “It is rare for a small and medium-sized Korean bio company to conduct clinical trials at major U.S. cancer centers,” emphasizing, “This proves that medical professionals both domestically and internationally have very high expectations for ‘hSTC810.’”

‘hSTC810’ is a novel drug candidate that first revealed its preclinical research results this year at global cancer conferences such as the American Association for Cancer Research (AACR) and the Society for Immunotherapy of Cancer (SITC), attracting significant attention from multinational pharmaceutical companies and academia.

In collaboration with the global animal testing company TransCure in France, STCube conducted experiments using a Cancer cell line Derived Xenograft (CDX) model with a single cell line tumor tissue. These experiments confirmed that the ‘hSTC810’ antibody inhibits the growth and shows therapeutic effects on cold tumors, which are resistant to existing immune checkpoint inhibitors. Additionally, CDX experiments using humanized mice with the lung cancer cell line (A549) revealed that the ‘hSTC810’ antibody suppresses tumor growth and is expressed more dominantly in tumor cells compared to the existing ‘PD-L1’.

STCube discovered that the target of ‘hSTC810,’ ‘BTN1A1,’ is expressed mutually exclusively with ‘PD-L1,’ the target of existing immune checkpoint inhibitors, producing a synergistic effect. It also acts as an upstream regulator of ‘PD-L1,’ which is used as a biomarker for existing immune checkpoint inhibitors. Furthermore, it was found that ‘BTN1A1’ shows a high expression rate in various solid tumors where ‘PD-L1’ is known to be minimally expressed.

A company representative explained, “We expect that ‘hSTC810’ will provide hope for treatment to cancer patients who do not benefit from existing immune checkpoint inhibitors through this global clinical trial,” adding, “While various combination therapies are currently being tested to overcome the limitations of treatments targeting ‘PD-1’ and ‘PD-L1,’ STCube is conducting global clinical trials on a novel target monotherapy using a new biomarker.”

They further added, “As a rarely attempted novel target global clinical trial recently, STCube’s clinical trial is expected to attract significant attention in the immune checkpoint inhibitor market.”

This content was produced with the assistance of AI translation services.