TIUM Bio announced on the 26th that additional partial responses (PR) were confirmed in some patients during the Phase 1b clinical trial of TU2218, an oral immuno-oncology drug under development.
TU2218 is currently undergoing a Phase 1b clinical trial at three clinical sites in the United States, evaluating safety, pharmacokinetics, and efficacy by administering TU2218 in combination with Keytruda to patients with advanced, progressive solid tumors. The trial is divided into three groups based on dosage.
Among these, in the highest dose group receiving 195 mg daily, efficacy analysis was possible for five patients, with two partial responses (pancreatic cancer, anal cancer) and three stable disease (SD) cases, resulting in an overall response rate (ORR) of 40% and a disease control rate (DCR) of 100%. These interim results were presented at the American Society of Clinical Oncology (ASCO) in June. Recently, a partial response was also confirmed in a lung cancer patient, increasing the total number of patients with confirmed partial responses in the Phase 1 trial to three.
Kim Hoon-taek, CEO of TIUM Bio, stated, “Despite the trial being conducted on patients with advanced solid tumors, positive therapeutic effects have been observed. Not only efficacy but also no dose-limiting toxicities have been found in the Phase 1a and 1b trials, demonstrating excellent safety, which raises expectations for this new drug.”
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