- 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.
Contacts:
Junseok Jang, Head of Corporate
Communications & Investor Relations
junseokjang@tiumbio.com
Suna Cho, Manager, Corporate
Communications & Investor Relations
sunacho@tiumbio.com
Da-ye Song, Manager, Corporate Communications & Investor
Relations
dayesong@tiumbio.com
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SOURCE TiumBio