TiumBio Unveils Promising Phase 1 Data for Hemophilia Treatment TU7710 at ISTH 2024

TiumBio Co., Ltd., a clinical-stage biopharmaceutical company based in Seongnam, South Korea, recently presented interim data from its Phase 1a clinical trial for TU7710, a new treatment for hemophilia, at the 32nd Congress of the International Society on Thrombosis and Haemostasis (ISTH). The company is keen on forming new global partnerships to further advance its innovative therapies.

Currently, TiumBio is conducting a double-blind, placebo-controlled Phase 1a clinical trial involving healthy adult males to assess the pharmacokinetics, pharmacodynamics, and safety of TU7710. The interim results presented at the ISTH conference involved 32 participants across four dosage groups, ranging from 100 μg/kg to 800 μg/kg.

The clinical data revealed that TU7710 has an average half-life of 10.4 to 16.6 hours across different dosage groups. This is significantly longer—5 to 7 times—than NovoSeven, a conventional hemophilia treatment that has a half-life of just 2.3 hours. Importantly, no serious adverse or thromboembolic events were observed during the study; most adverse events reported were mild.

The term "half-life" refers to the duration it takes for the concentration of a drug in the blood to reduce by half, which is crucial for understanding the drug's effectiveness over time. Due to the short half-life of NovoSeven, hemophilia A or B patients with inhibitors often need to receive the treatment every two hours during bleeding episodes, posing a significant burden on both patients and healthcare providers.

TU7710 is a recombinant factor VIIa with a prolonged half-life, developed using TiumBio's transferrin fusion technology. TiumBio plans to initiate a Phase 1b clinical trial of TU7710 in hemophilia patients in Europe later this year.

"NovoSeven has been a mainstay for hemophilia treatment, with $10 billion in sales over the past nine years. However, its short half-life results in unmet medical needs for both patients and healthcare professionals," stated Hun-Taek Kim, Ph.D., MBA, CEO of TiumBio. "The extended half-life of TU7710 has been demonstrated in preclinical and early human studies, highlighting its potential to provide significant clinical and commercial value."

TiumBio Co., Ltd. is dedicated to the discovery and development of innovative treatments for rare and incurable diseases. The company's leading pipeline assets include merigolix (code name: TU2670), TU2218, and TU7710, each at various stages of clinical development. Merigolix is an oral GnRH receptor antagonist for endometriosis and uterine fibroids, currently in global Phase 2 clinical trials. TU2218 is an oral immune-oncology therapy that targets TGF-β and VEGF pathways to enhance response rates in cancer patients when used alongside immune checkpoint inhibitors. TU7710, with its extended half-life, aims to offer more clinical benefits to hemophilia patients with inhibitors.

With a focus on easing the burden of debilitating diseases, TiumBio leverages its expertise in drug development to bring innovative treatments to market. The promising results from the TU7710 trial mark an important step forward in addressing the unmet needs in hemophilia treatment and improving the quality of life for patients.