TiumBio Co., Ltd. has announced the dosing of the first patient in its Phase 2 clinical trial of TU2218, a novel oral immuno-oncology drug. This trial marks a significant step in evaluating the potential of TU2218 as a treatment for advanced solid tumors.
The Phase 2a trial is designed to assess the safety and efficacy of TU2218 in combination with Keytruda (pembrolizumab) in patients with head and neck squamous cell carcinoma (HNSCC), biliary tract cancer (BTC), and colorectal cancer (CRC). The trial is initially being conducted at Seoul National University Hospital and Asan Medical Center in South Korea, with plans to expand to hospitals in the United States. The first patient dosed has HNSCC.
TU2218: A Novel Dual Inhibitor
TU2218 is a potentially first-in-class oral dual inhibitor targeting transforming growth factor beta receptor 1 (TGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2). These pathways, TGF-β and VEGF, are known to suppress the activity of immune checkpoint inhibitors (ICIs). By blocking these pathways, TU2218 is expected to enhance the efficacy of ICIs like Keytruda.
Hun-taek Kim, Ph.D., MBA, CEO of TiumBio, stated that HNSCC presents a high unmet medical need, with average survival rates for first-line treatments being approximately one year. Kim added, "We have selected cancer types for the Phase 2 clinical trial based on other trials that demonstrated strong anti-cancer effects from targeting TGF- β or VEGF pathways. Our goal is to develop TU2218 as a first-line treatment for HNSCC."
Prior Clinical Data
In Phase 1a and 1b clinical trials, TiumBio evaluated the safety, pharmacokinetics, and pharmacodynamics of TU2218 as a monotherapy and in combination with Keytruda in 41 patients with advanced solid tumors. These trials helped determine the dose levels for the Phase 2 trial. Notably, in the Phase 1b trial, among 10 patients with advanced solid tumors who received a 195mg daily dose of TU2218 with Keytruda, three patients achieved partial response (PR) and five patients had stable disease (SD), yielding an 80% disease control rate (DCR).
HNSCC and the Need for New Treatments
Head and neck squamous cell carcinoma (HNSCC) includes malignant tumors of the oral cavity, throat, larynx, or salivary glands. Standard treatment typically involves surgery and radiation therapy. According to Global Data, the number of HNSCC patients worldwide was estimated to be around 610,000 in 2023 and is projected to exceed 670,000 by 2030, underscoring the need for more effective treatments.
