TiumBio Presents Phase 1b Interim Results for TU2218 in Combination with Pembrolizumab at ASCO 2024 Annual Meeting

• Poster presentation features the interim data from an ongoing Phase 1b clinical trial of TU2218 plus Keytruda combination therapy in patients with advanced solid tumors
• A 40% overall response rate (ORR) and 100% disease control rate (DCR) were achieved in high-dose cohort (195 mg/day)
• TU2218 was well-tolerated as a monotherapy and combination therapy with pembrolizumab, with no dose limiting toxicities (DLTs) to date

BOSTON and SEONGNAM, South Korea, June 1, 2024 /PRNewswire/ -- TiumBio Co., Ltd. (Kosdaq: 321550), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases, announced interim results from the Phase 1b clinical trial of TU2218 in combination with pembrolizumab at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

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 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 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.

About TiumBio Co., Ltd.

TiumBio (Kosdaq: 321550) is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapeutics for patients with rare and incurable diseases. Its mission is to expand the hope and happiness of mankind through our science. TiumBio boasts three leading pipeline assets: merigolix (code name: TU2670), TU2218, and TU7710, all in various stages of clinical development.

Merigolix is a once-daily, oral GnRH receptor antagonist being developed for the treatment of endometriosis and uterine fibroids and is undergoing in global Phase 2 clinical trials. TU2218 is a first-in-class oral immune-oncology therapy targeting TGF-β and VEGF pathways to promote response rates in cancer patients when used in combination with immune checkpoint inhibitors. TU7710 is a novel rFVIIa designed to extend its half-life in order to provide more clinical benefits to hemophilia patients with inhibitors.

With its expertise in drug development, TiumBio is committed to the discovery and development of innovative treatments to ease the burden of debilitating diseases. For further information, visit our website at www.tiumbio.com/en and connect with us on LinkedIn.

Contacts:

Junseok Jang, Head of Corporate Communications & Investor Relations

[email protected] 

Suna Cho, Manager, Corporate Communications & Investor Relations

[email protected] 

Da-ye Song, Manager, Corporate Communications & Investor Relations

[email protected]

SOURCE TiumBio