TiumBio Shares Phase 1b Interim Results for TU2218 with Pembrolizumab at ASCO 2024

TiumBio Co., Ltd., a clinical-stage biopharmaceutical firm, unveiled promising interim results from its Phase 1b clinical trial at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2024. The study focuses on the combination therapy of TU2218 and pembrolizumab (Keytruda) in patients with advanced solid tumors.

TU2218 is an innovative oral drug that targets both transforming growth factor beta receptor 1 (TGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2). These pathways, prevalent in the tumor microenvironment, often counteract the efficacy of immune checkpoint inhibitors. By inhibiting these pathways, TU2218 aims to enhance the effectiveness of immunotherapies.

The ongoing Phase 1b trial in the United States, identified as NCT05784688, assesses the safety, pharmacokinetics, and preliminary efficacy of TU2218 combined with Keytruda across three dosage levels: 105 mg, 150 mg, and 195 mg per day. The ASCO meeting highlighted findings from 12 patients involved in this trial. The complete data set, encompassing 18 patients, is expected to be released later in 2024.

The presentation at the ASCO meeting detailed outcomes from the recommended phase 2 dose (RP2D) cohort of 195 mg/day. In this specific group, five patients showed a 40% overall response rate (ORR) and a 100% disease control rate (DCR), with two patients achieving partial response (PR) and three patients maintaining stable disease (SD). Across all dosage groups, patients exhibited a 16.7% partial response rate, a 50.0% stable disease rate, and a 25.0% progression of disease (PD) rate. TU2218 demonstrated good tolerability both as a monotherapy and in combination with pembrolizumab, with no dose-limiting toxicities observed.

Dr. Hun-Taek Kim, CEO at TiumBio, expressed optimism about the trial's preliminary efficacy and favorable safety profile. He anticipates the release of comprehensive data in the latter half of the year and announced plans to initiate a Phase 2a clinical trial targeting head and neck cancer, biliary tract cancer, and colorectal cancer. This next phase aims to develop novel treatments for patients with limited therapeutic options.

TiumBio Co., Ltd., listed on Kosdaq (321550), is dedicated to discovering and developing new therapeutics for rare and incurable diseases. The company's mission is to enhance human well-being through scientific innovation. TiumBio's leading pipeline assets include merigolix (TU2670), TU2218, and TU7710. Merigolix, a daily oral GnRH receptor antagonist, is in Phase 2 clinical trials for endometriosis and uterine fibroids. TU7710, a novel recombinant Factor VIIa (rFVIIa), is designed to extend its half-life, providing more clinical benefits for hemophilia patients with inhibitors.

With its robust expertise in drug development, TiumBio is committed to alleviating the burden of debilitating diseases through groundbreaking treatments.