TIUM Bio announced on the 2nd that it has started the first patient dosing in the Phase 2 clinical trial of TU2218, an oral immuno-oncology drug under development.
TU2218 is being developed as a therapeutic agent that enhances the efficacy of existing immune checkpoint inhibitors by simultaneously blocking the pathways of transforming growth factor (TGF)-beta (β), which is closely related to cancer progression, metastasis, and immune evasion, and vascular endothelial growth factor (VEGF), which is involved in angiogenesis within the tumor microenvironment and inhibits immune cell infiltration into tumors, thereby interfering with the activity of immuno-oncology drugs.
In previous Phase 1a and 1b clinical trials involving 41 patients with advanced solid tumors, the safety, pharmacokinetics, and pharmacodynamics of the combination therapy of TU2218 and Keytruda were evaluated to determine the dosage for Phase 2. Among 10 patients dosed with 195 mg daily in Phase 1b, 3 showed partial response (PR) with a reduction of cancer cells by more than 30%, and 5 exhibited stable disease (SD) with no significant change in tumor size, resulting in a disease control rate (DCR) of 80%.
In the upcoming Phase 2a trial, the anti-cancer efficacy and safety of the combination therapy with Keytruda will be evaluated in patients with head and neck cancer, cholangiocarcinoma, and colorectal cancer. The Phase 2 trial will begin in South Korea at Seoul National University Hospital and Asan Medical Center and will expand to the United States.
The first patient dosed this time is a head and neck cancer patient. Head and neck cancer refers to malignant tumors occurring in the oral cavity, pharynx, larynx, salivary glands, and other areas. Surgery, chemotherapy, and radiotherapy are standard treatments, but immuno-oncology drugs such as Keytruda have also been approved and are widely used. According to market research firm PharmaIntelligence, as of last year, the estimated number of head and neck cancer patients worldwide was approximately 610,000, and the number is expected to exceed 670,000 by 2030 due to a continuous increase in patients.
Kim Hoon-taek, CEO of TIUM Bio, stated, "Head and neck cancer is a disease with a high unmet medical need as the average survival rate with first-line treatment is about one year. We selected cancer types based on clinical trials that showed good anti-cancer effects in head and neck cancer through the mechanism of inhibiting TGF-β and VEGF, and we aim to develop TU2218 as a first-line treatment for head and neck cancer."
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