TU7710, long-acting recombinant activated factor VII, demonstrated a 5 to 7 times longer half-life in a Phase 1 study than that of NovoSeven, a conventional hemophilia treatment for patients who develop inhibitors TiumBio presented interim Phase 1a clinical data of TU7710 and discussed potential partnership at the ISTH 2024
SEONGNAM, South Korea, June 24, 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 today that the company presented clinical outcomes of its hemophilia treatment, TU7710, at the 32nd Congress of the International Society on Thrombosis and Haemostasis (ISTH) and embarked on building new global partnerships.
TiumBio is currently conducting a double-blind, placebo-controlled Phase 1a clinical trial evaluating the pharmacokinetics, pharmacodynamics, and safety of TU7710 in healthy adult males. At the conference, interim results were presented for a total of 32 participants across cohorts ranging from 100 μg/kg (Cohort 1) to 800 μg/kg (Cohort 4) dosing groups.
In the clinical results presented at the ISTH conference, TU7710 showed an average half-life ranging from 10.4 to 16.6 hours across dosage groups. This is 5 to 7 times longer than that of NovoSeven, a conventional hemophilia drug for patients with neutralizing antibodies against standard therapies, which has a known half-life of 2.3 hours. Furthermore, no serious adverse and thromboembolic events occurred, and most of adverse events were mild.
Half-life refers to the time it takes for the blood concentration of a drug to decrease by half and is related to the sustainability of drug efficacy. Due to its short half-life, when bleeding occurs, hemophilia A or B patients with inhibitors are recommended to receive NovoSeven every two hours until hemostasis is achieved, which places a burden on patients and healthcare providers.
TU7710 is recombinant factor VIIa with an extended half-life developed by TiumBio’s transferrin fusion technology. TiumBio plans to initiate a Phase 1b clinical trial of TU7710 in hemophilia patients in Europe in the second half of this year.
"NovoSeven has been widely used for hemophilia patients, bringing in $10 billion in sales over the past 9 years. However, due to its short half-life, there are significant unmet medical needs for patients and healthcare professionals," said Hun-Taek Kim, Ph.D., MBA, CEO at TiumBio. "The extended half-life of TU7710 has been demonstrated in preclinical and first-in-human studies, which further enhances the commercial value of the novel drug," 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.
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Junseok Jang, Head of Corporate Communications & Investor Relations
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Suna Cho, Manager, Corporate Communications & Investor Relations
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Da-ye Song, Manager, Corporate Communications & Investor Relations
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