(Health Korea News / Lee Si-woo) It was revealed that Tium Bio’s immunotherapy anticancer drug candidate ‘TU2218’ has confirmed its potential as an anticancer drug, with partial remission observed in the interim evaluation results of phase 1b clinical trials. On the 14th (local time), Tium Bio announced the research results containing these contents at the ‘European Society for Medical Oncology (ESMO)’.
‘TU2218’ is an oral immunotherapy drug being developed with the goal of improving the therapeutic effects of existing immunotherapy drugs such as Keytruda (ingredient name: pembrolizumab) by blocking factors that interfere with the activity of immunotherapy drugs in the tumor microenvironment and improving the tumor microenvironment. Currently, a phase 1b clinical trial of the combination of TU2218 and Keytruda is being conducted at three clinical institutions in the United States targeting patients with terminal solid tumors. Of the 19 patients recruited, all patients have completed the medication, except for four patients who are currently taking the medication.
The purpose of the phase 1b clinical trial is to evaluate the safety, pharmacokinetics, and pharmacodynamics of the combination therapy of TU2218 and Keytruda, and to find the optimal dose for the subsequent phase 2a clinical trial. Patients participating in the clinical trial were divided into three groups and received TU2218 together with Keytruda at different doses (105 mg/day, 150 mg/day, and 195 mg/day).
According to the company, in the phase 1b clinical trial results of TU2218 presented at the ESMO Society, among the 16 patients whose tumors could be evaluated, 3 showed a partial response (PR) in which cancer cells were reduced by more than 30% compared to the baseline treatment, and 7 patients showed stable disease (SD) in which there was no significant change in tumor size. By group, among the 10 patients in the 195 mg daily dose, which is the high dose among the three dose groups and the recommended phase 2 dose, 3 showed PR and 5 showed SD, achieving an objective response rate (ORR) of 30% and a disease control rate (DCR) of 80%.
The three patients who confirmed a partial response (PR) were lung cancer, pancreatic cancer, and anal cancer patients, respectively, and all of them had received an average of two or more types of anticancer treatment before participating in the clinical trial, but had no treatment effect. However, the company explained that the anticancer effect was observed after receiving TU2218 and Keytruda.
In terms of safety, the company emphasized that it demonstrated excellent safety and tolerability, with all treatment emergent adverse events of Grade 2 or lower occurring in a total of 41 patients recruited for the Phase 1a (n=22) and Phase 1b clinical trials (n=19) except for three Grade 3 adverse events (pruritus, maculopapular rash, and fatigue).
Kim Hoon-taek, CEO of Tium Bio, said, “We have confirmed the clinical value of improving the survival time and quality of life of terminally ill cancer patients by inhibiting the progression of cancer as a result of combined administration of TU2218 and Keytruda.” He added, “As an anticancer drug that is safe and convenient to take for a long period of time, we will actively pursue technology transfer and commercialization by proving its potential as a combination partner with anti-PD-1 antibodies (or Keytruda).”
Meanwhile, TU2218’s phase 2a clinical trial selected three cancers, biliary tract cancer, head and neck cancer, and colorectal cancer, received approval for the clinical trial plan (IND) in the first half of this year, and recently began recruiting patients with biliary tract cancer and head and neck cancer.
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