[ASCO] Kim Hun-taek, CEO of Tiumbio: “‘TU2218+바카라사이트 통장’ combination therapy shows potential to be first-in-class”

[by Lee, Young Sung] Tiumbio has unveiled promising initial results from the Phase 2a clinical trial of its anticancer drug candidate, ‘TU2218 (development code),’ in combination with MSD (Merck, USA)’s immune checkpoint inhibitor, ‘바카라사이트 통장.’ This development has heightened the prospects for commercialization. Tiumbio aims to position this combination therapy as a ‘first-in-class’ treatment. TU2218 is a small molecule compound designed to simultaneously inhibit the TGF-β and VEGF signaling pathways.

This clinical data was recently presented during the Trials in Progress (TPS) session at the American Society of Clinical Oncology 2025 (바카라사이트 통장) Annual Meeting held in Chicago, USA. The TPS session highlights the background, objectives, and study design of ongoing clinical trials.

The combination therapy of ‘TU2218 + 바카라사이트 통장’ is currently being evaluated for the treatment of head and neck cancer (HNSCC) and biliary tract cancer (BTC). In head and neck cancer, the combination therapy demonstrated a partial response rate (PR) of 64% (7 out of 11 patients) in first- and second-line settings. This rate surpasses the objective response rate (ORR) of 36% observed with the standard first-line treatment, '바카라사이트 통장 + chemotherapy,' and the ORR of 16% seen with '바카라사이트 통장' monotherapy. These clinical data were drawn from the 'KEYNOTE-048 (phase 3) clinical trial,' although no direct head-to-head comparison was made with the 'TU2218 + 바카라사이트 통장' combination therapy. The ORR is defined as the sum of partial response (PR) and complete response (CR), but in studies where CR is not observed, ORR is sometimes calculated based solely on PR.

For biliary tract cancer (BTC), the combination therapy of 'TU2218 + 바카라사이트 통장' was administered to patients who had received second-line or later treatment. Among these patients, 4 out of 23 achieved a PR, while 7 demonstrated stable lesions (SD), suggesting similarly promising outcomes.

In an interview with <THE BIO at ASCO on June 3 (local time), Kim Hun-taek, CEO of Tiumbio, remarked, "The data results so far are encouraging," and added, "We are developing this as a 바카라사이트 통장in-class treatment and are also actively pursuing technology transfer opportunities."

Specifically, Kim elaborated, "In the existing first-line treatment clinical trial of '바카라사이트 통장+chemotherapy' combination therapy for head and neck cancer, the ORR was approximately 36%. However, based on Phase 2 data, the TU2218 and 바카라사이트 통장 combination is expected to achieve an ORR of around 60%, and we believe it will be at least 50% or higher." Kim further added, "Consequently, if we achieve an ORR of 50% or higher in first-line treatment, it could establish this combination as the most effective treatment option available."

"Compared to the initial data from competing therapies currently under development, the TU2218 and 바카라사이트 통장 combination is demonstrating results that are at least equivalent in efficacy," said Kim while expressing optimism.

A notable competing therapy is Bicara Therapeutics' 'EGFRxTGF-β' targeting dual antibody 'BCA101'. In a phase 1 clinical trial for HPV-negative recurrent/metastatic head and neck cancer, the 'BCA101' and 바카라사이트 통장 combination therapy recorded an ORR of 65% and a CR of 3% among HPV-negative patients.

Regarding biliary tract cancer, Kim added, "Although the TU2218 and 바카라사이트 통장 combination therapy was administered as a second-line treatment, the positive data generated so far has raised hopes that it could also be applicable as a first-line treatment."

According to the clinical data released this time, in the head and neck cancer cohort of patients receiving 바카라사이트 통장 and second-line treatment, 7 out of 11 evaluable patients achieved PR, while 1 exhibited SD. In the biliary tract cancer cohort for second and higher-line treatment, 4 out of 23 evaluable patients demonstrated PR, and 7 showed SD. These findings represent meaningful anti-tumor responses (data cutoff as of April 30, 2025).

Accordingly, the company stated that the successful completion of the 바카라사이트 통장 2, 바카라사이트 통장 1 Futility Analysis has become an important milestone, reinforcing the possibility of continued development.

In addition, 바카라사이트 통장-related adverse events (TRAEs) of grades 1 and 2 were most commonly observed in the study subjects, including rash (approximately 10%), stomatitis (approximately 6.7%), and pruritus (approximately 6.7%). The company noted that most Grade 3 or higher TRAEs, such as nausea (about 4%) and rash (about 4%), disappeared following temporary dose reduction or administration of the trial medication.

"We plan to establish a clinical site in the United States later this year to accelerate the progress of the clinical trial," 바카라사이트 통장 said.

Meanwhile, TU2218 is a ‘small-molecule compound' that simultaneously targets the TGF-β and VEGF signaling pathways, but it is not a dual antibody. By inhibiting TGF-β (Transforming Growth Factor-β), TU2218 mitigates immunosuppression, while inhibition of VEGF (Vascular Endothelial Growth Factor) reduces tumor growth by preventing angiogenesis and immune evasion. This combined clinical trial leverages a mechanism of action that creates a more favorable environment for immune responses with TU2218, while 바카라사이트 통장 directly activates immune T cells to attack cancer cells.