TiumBio Submits CTA for Phase 1b Clinical Trial of TU7710, a Long-acting Recombinant Activated Factor VII, in Hemophilia A or B Patients

• TU7710 has the potential to be a highly effective and long-acting treatment for bleeding episodes as well as for preventing bleeding during surgery or invasive procedures in hemophilia patients with inhibitors
• Interim results from an ongoing Phase 1a study in healthy male volunteers will be presented at International Society on Thrombosis and Haemostasis (ISTH) 2024 Congress

BOSTON and SEONGNAM, South Korea, March 26, 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, has announced the filing of a Clinical Trial Application (CTA) with the Italian Medicines Agency (AIFA) and the Spanish Agency of Medicines and Medical Products (AEMPS) to initiate a Phase 1b study of TU7710, a novel recombinant activated factor VII (rFVIIa) for hemophilia patients with inhibitors.

The Phase 1b clinical trial is an open-label, single and multiple-dose escalation study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of TU7710, aiming to determine the recommended Phase 2 dose. The trial will enroll up to 18 hemophilia A or B patients with inhibitors and will be conducted in Italy and Spain.

TU7710 is a long-acting rFVIIa with a half-life 6-7 times longer than NovoSeven, a rFVIIa widely accepted as a standard treatment, which is achieved through TiumBio's transferrin fusion protein technology. Thus, it will substantially reduce both burdens of treatment costs and frequent dosing of NovoSeven for patients.

TiumBio is currently conducting a Phase 1a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TU7710 in healthy adult male volunteers. Interim results from the study will be present at the ISTH 2024.

"We believe that TU7710 will become a highly effective medication that can manage bleeding episodes and prevent bleeding during surgical operations with its longer half-life compared to NovoSeven," said Hun-taek Kim, Ph.D., MBA, Founder and CEO of TiumBio. "Our team has been developing TU7710 as an innovative hemophilia treatment option, which is strengthened by our experience with Afstyla, an FDA-approved recombinant Factor VIII originally discovered by our R&D team members at SK Chemicals," he added.

Hemophilia is a congenital bleeding disorder caused by the absence of deficiency of blood clotting factors. Blood coagulation factor VIII deficiency is classified as hemophilia type A, and blood coagulation factor IX deficiency is classified as hemophilia type B.

rFVIIa is a bypassing agent therapy for patients with hemophilia A or B who develop neutralizing antibodies, but there are currently only limited treatment options available on the market, including the leading drug NovoSeven, a product by Novo Nordisk.

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-? 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