On June 1, 2024 TiumBio Co., Ltd. (Kosdaq: 321550), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases, reported interim results from the Phase 1b clinical trial of TU2218 in combination with pembrolizumab at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, TiumBio, JUN 2, 2024, View Source [SID1234643955]).
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TU2218 is a novel oral dual inhibitor targeting transforming growth factor beta receptor 1 (TGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2). TGF-ß and VEGF pathways in tumor microenvironment interfere with the anti-tumor activity of immune checkpoint inhibitors, so TU2218 is expected to maximize the efficacy of immuno-therapies by inhibiting them.
TiumBio’s ongoing Phase 1b clinical trial (NCT05784688) in the United States evaluates safety, pharmacokinetics, and preliminary efficacy of TU2218 in combination with Keytruda (pembrolizumab) in patients with advanced solid tumors. The study consists of three dosage groups (105 mg, 150 mg, and 195 mg/day), and the presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting included results from 12 patients across the three cohorts. Data from the full Phase 1b trial, which includes 18 patients, will be available in the second half of 2024.
In the poster released at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, five patients treated at the recommended phase 2 dose (RP2D) of 195mg/day TU2218 in combination with pembrolizumab demonstrated an ORR of 40% at PR (n=2) and 60% at SD (n=3) with a DCR of 100%. And across all dosage groups, patients (n=12) receiving the combination therapy showed PR at 16.7% (n=2), SD at 50.0% (n=6) and PD at 25.0% (n=3). In this study, TU2218 was well-tolerated as a combination therapy with pembrolizumab, showing no signs of DLTs, which is consistent with a previous monotherapy trial.
"We are encouraged by the preliminary efficacy results with a favorable safety profile in patients with advanced tumors and are looking forward to top-line data from the study, which is expected in the second half of this year," said Hun-Taek Kim, Ph.D., MBA, CEO at TiumBio. "We plan to initiate a Phase 2a clinical trial in head and neck cancer, biliary tract cancer, and colorectal cancer to develop an innovative novel drug for patients with limited treatment options," he added.