TiumBio Co., Ltd. (KRX: 321550. KQ), a clinical-stage biopharmaceutical company focusing on discovering and developing innovative therapeutics for patients with rare and incurable diseases, today announced that the Phase 1a results of TU2218 will be presented at the 2023 European Society of Medical Oncology (ESMO) Congress and the Society for Immunotherapy of Cancer (SITC) 2023, which are to be held in October and November, respectively.
TU2218 is an oral dual inhibitor targeting transforming growth factor bet (TGF-ß) and vascular endothelial growth factor (VEGF). Its Phase 1a clinical study (NCT05204862) demonstrated the safety, tolerability, pharmacokinetics, and preliminary efficacy of TU2218 monotherapy in patients with advanced solid tumors in the U.S. and South Korea.
Professor Oh Do-Youn, from the Department of Oncology at Seoul National University, serves as the principal investigator of the clinical trial and will present a poster presentation on the Phase 1 data at the ESMO Congress, scheduled for October 2023. TiumBio will also present the data at the 37th Annual Meeting of SITC, taking place in Boston in November 2023. Through these opportunities, TiumBio intends to inform academic experts and representatives from global pharmaceutical companies about findings from studies of TU2218, thereby enhancing global awareness.
TU2218 is a dual kinase inhibitor that inhibits TGF-β and VEGF. It is expected to significantly improve the response rate in patients who don’t respond to or who are refractory to immune-checkpoint inhibitors, including anti-PD-(L)1 therapies. Overexpressed TGF-β in the tumor microenvironment is reported as a major factor that hinders the efficacy of anti-PD1 drugs. VEGF is known to be involved in angiogenesis around tumor cells. In April of this year, TiumBio presented at the American Association for Cancer Research (AACR) the results of preclinical studies in tumor cell and animal models. These studies demonstrated that the combination of TU2218 and PD-1 inhibitors effectively enhanced the anticancer treatment effect compared to monotherapy.
Based on the successful preclinical research results of TU2218, TiumBio signed a ‘Clinical Trial Collaboration and Supply Agreement’ with Merck (MSD) in June last year. TiumBio is currently conducting a Phase 1b clinical trial (NCT05784688) of TU2218 in combination with Keytruda at three hospitals in the United States, and plans to present clinical results from the study at an global oncology conference in the first half of next year.
“We are pleased to see the potential of TU2218 in the monotherapy clinical trial and announce the clinical results at global conferences,” said Hun-taek Kim, Ph.D., MBA, Founder and CEO, TiumBio. “We plan to initiate a Phase 2a clinical trial next year for combination therapy with Keytruda in cancer types where the anti-cancer efficacy and clinical value of TU2218 can be maximized,” he added.