(Health Korea News / Yu Ji-in) Tium Bio announced on the 26th that it had confirmed additional partial response (PR) patients in the phase 1b clinical trial of ‘TU2218’, an oral immune anticancer drug under development.
This brings the total number of patients confirmed to have a PR response in the phase 1b clinical trial of ‘TU2218’ to three. Following the two pancreatic cancer and anal cancer patients who previously showed PR results, the new patient who showed a PR response this time is a lung cancer patient.
Tium Bio is currently conducting a phase 1b clinical trial to evaluate the safety, pharmacokinetics, and efficacy of ‘TU2218’ and ‘Keytruda’ in combination in patients with advanced terminal solid cancer at three clinical institutions in the United States, including Texas and Washington.
According to Tium Bio, the phase 1b clinical trial consists of three dose groups (TU2218 105 mg, 150 mg, 195 mg day). The highest dose of 195 mg per day was determined as the recommended dose for phase 2 clinical trials.
In June, Tium Bio participated in the American Society of Clinical Oncology (ASCO 2024) and announced interim results that among the 5 patients who received 195 mg of ‘TU2218’ for whom efficacy analysis was possible, 2 had partial responses (PR) and 3 had stable disease (SD), achieving an overall response rate (ORR) of 40% and a disease control rate (DCR) of 100%.
TiumBio CEO Kim Hoon-taek said, “Although the clinical trial for the combination therapy of ‘TU2218’ and ‘Keytruda’ is being conducted on patients with terminal solid cancer, positive therapeutic effects are being confirmed.” He added, “In the phase 1a and 1b clinical trials conducted on 34 patients so far, not only efficacy but also safety were shown to be excellent, with no dose-limiting toxicity found, raising expectations for the new drug.”
Meanwhile, Tium Bio has selected three cancers as the target cancers for the Phase 2 clinical trial of Keytruda combination therapy with ‘TU2218’: bile duct cancer, head and neck cancer, and colon cancer, and plans to begin recruiting patients next month.
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