TiumBio Begins Phase 2 Trial of Oral Immuno-Oncology Drug TU2218

TiumBio Co., Ltd., a clinical-stage biopharmaceutical company specializing in innovative treatments for rare and incurable diseases, has initiated its Phase 2 clinical trial of TU2218. This first-in-class oral dual inhibitor targets transforming growth factor beta receptor 1 (TGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2). The trial began with dosing the first patient diagnosed with head and neck squamous cell carcinoma (HNSCC).

TU2218 is designed to improve the efficacy of immune checkpoint inhibitors (ICIs) by blocking the TGF-ß and VEGF pathways, which are known to suppress the activity of ICIs. The Phase 2a trial aims to evaluate both the safety and efficacy of TU2218 in combination with Keytruda (pembrolizumab), initially in patients with HNSCC and biliary tract cancer (BTC), and later in colorectal cancer (CRC) patients.

The Phase 1a and 1b trials assessed TU2218 as a monotherapy and in combination with Keytruda in 41 patients with advanced solid tumors. These trials focused on determining the appropriate dose levels for the Phase 2 trials by evaluating the safety, pharmacokinetics, and pharmacodynamics of TU2218. The recommended dose level of 195mg daily was established for the Phase 2 trials.

The Phase 2 trial has commenced at Seoul National University Hospital and Asan Medical Center in South Korea, with future plans to expand the study to hospitals in the United States. The first participant to receive the treatment was a patient with HNSCC, a type of cancer affecting the oral cavity, throat, larynx, or salivary glands. Traditional treatment for HNSCC often involves surgery and radiation therapy, yet the disease remains a significant medical challenge. As of 2023, there are approximately 610,000 HNSCC patients worldwide, a number projected to rise to over 670,000 by 2030.

"HNSCC has a very high unmet medical need, given the average survival rate of roughly one year for first-line treatments," said Hun-taek Kim, Ph.D., MBA, CEO of TiumBio. “Our selection of cancer types for the Phase 2 trial is based on previous studies that showed strong anti-cancer effects from targeting the TGF-ß or VEGF pathways. Our ultimate aim is to position TU2218 as a first-line treatment for HNSCC."

In the Phase 1b trial, 10 patients with advanced solid tumors who received a daily dose of 195mg of TU2218 along with Keytruda showed promising results. Three patients experienced partial response (PR), and five patients achieved stable disease (SD), resulting in an 80% disease control rate (DCR).

TiumBio is committed to discovering and developing novel therapeutics to address some of the most challenging diseases. With a robust pipeline that includes merigolix (TU2670) for endometriosis and uterine fibroids, TU2218 for enhancing the response rates in cancer patients, and TU7710 for hemophilia, TiumBio continues to make significant strides in clinical research and drug development.

TiumBio's efforts are centered on alleviating the burden of debilitating diseases through innovative scientific advancements. The company remains dedicated to expanding hope and improving the quality of life for patients worldwide.