TU7710 / Tium Bio - LARVOL DELTA

[HIT Algong] Tium Bio, Hemophilia Treatment 'TU7710' Clinical Phase 1b Approval [Google translation] (HIT News) - "Approval of a clinical phase 1b trial to evaluate the safety, pharmacokinetics, and pharmacodynamics of TU7710 in patients with hemophilia A or B. The primary objectives are to evaluate the safety of TU7710 after single and repeated intravenous administration, determine the recommended phase 2 dose, and evaluate the immunogenicity of TU7710 after intravenous administration. The expected clinical trial end date is December 31 of this year. The target number of subjects is 18 (the goal is to recruit 6 in Armenia)."

New P1 trial • Hemophilia

TiumBio confirms safety of TU7710 for hemophilia (Korea Biomedical Review) - P1a | N=40 | NCT06025552 | Sponsor: TiumBio Co., Ltd. | "In a public disclosure on Monday, TiumBio announced the top-line results of the phase 1a trial of TU7710. The phase 1a study was conducted in 40 healthy adult males....In phase 1a, the Cmax of TU7710 increased proportionally with the dose, from 8.62 IU/ml at the lowest dose (0.1 mg/kg) to 190.10 IU/ml at the highest dose (1.6 mg/kg). The dose-specific treatment-emergent adverse event (TEAE) rate was highest at 83.3 percent (five patients) at the 0.8 mg/kg dose and decreased to 33.3 percent (two patients) at the highest dose of 1.6 mg/kg. The incidence of TEAEs in the placebo group was 50 percent....Notably, in the 0.4 mg/kg dose group, some patients had half-lives of more than 30 hours."

P1 data • Hemophilia • Hemophilia A • Hemophilia B

Study of TU7710 in Warfarin Anti-coagulated Healthy Male Subjects (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: TiumBio Co., Ltd. | Recruiting ➔ Completed | Phase classification: P1a ➔ P1 | Trial completion date: Feb 2024 ➔ Aug 2024 | Trial primary completion date: Feb 2024 ➔ Aug 2024

Phase classification • Trial completion • Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

Phase 1a Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Single Ascending Doses of Intravenous TU7710 in Warfarin Pretreated Healthy Male Subjects (ISTH 2024) - P1a | "Cohort 1 (100 μg/kg) and Cohort 2 (200 μg/kg) have been completed, while Cohort 3 to 5 is currently ongoing. Following TU7710 dosing, a significant increase in plasma FVIIa activity was observed in 6 PK data from each Cohort. The average mean residence times (MRTs) were 6.15 and 7.47 hours; the median terminal half-life was 13.80 and 12.39 hours; and the mean maximum plasma FVIIa activity (Cmax) was 8.62 and 13.46 IU/mL for Cohort 1 and 2, respectively (Table 1)."

Clinical • P1 data • PK/PD data • Hematological Disorders • Hemophilia • Rare Diseases

TiumBio Secures KRW 38.5 Billion in Anticipation of Upcoming Clinical Data (PRNewswire) - "TiumBio Co., Ltd...today announced the completion of a stock financing of 2,320,185 shares of its convertible preferred shares at a price of KRW 8,620 per share in a private placement. TiumBio sold the stock to SK Chemicals Co., Ltd. securing 20 billion won to fund its development of lead pipeline assets...The funds will be primarily allocated to support its clinical programs that include a Phase 2 trial of merigolix, a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in endometriosis, and a Phase 1b trial of TU2218, a first-in-class oral immune-oncology therapy targeting TGF-β and VEGF, in combination with pembrolizumab, and a Phase 1 trial of TU7710, a recombinant protein designed to treat people with hemophilia who have inhibitors...'we look forward to sharing results with all stakeholders from the ongoing Phase 2 trial in endometriosis....expected in the first half of 2024.'"

Financing • P2 data • Endometriosis • Hemophilia • Oncology • Solid Tumor • Women's Health

Study of TU7710 in Warfarin Anti-coagulated Healthy Male Subjects (clinicaltrials.gov) - P1a | N=40 | Recruiting | Sponsor: TiumBio Co., Ltd.

New P1 trial • Hematological Disorders • Hemophilia • Rare Diseases

Tium Bio, which had no L/O performance, reduced its sales to less than 100 million won [Google translation] (thebell) - "Compared to 2020, sales decreased by about 1 billion won (about 95%) and operating loss increased by 19.4 billion won (about 146%). Net loss increased by 20 billion won to 32.4 billion won during the same period....The company announced that its operating loss increased last year due to clinical development costs for NBP604 (hemophilia treatment candidate) ; NCE403 (endometriosis treatment candidate)..."

Commercial • Endometriosis • Genetic Disorders • Hemophilia • Women's Health

Tium Bio expects clinical momentum - Sangsangin [Google translation] (eDaily) - "Tium Bio is also preparing for global clinical trials of TU7710, a hemophilia treatment, in early 2022. It is a bypass factor (resistant patient) hemophilia treatment pipeline, and is currently preparing for clinical trials by selecting IQVIA as a clinical contract organization (CRO) company. It is expected to enter phase 1 clinical trials in early 2022 and be completed in early 2023. The number of patients is a rare disease, so 10 patients are included."

Licensing / partnership • New P1 trial • Genetic Disorders • Hemophilia

Tium Bio, Immune anticancer drug ’TU2218’ applied for Phase 1/2 [Google translation] (docdocdoc.co.kr) - "Tium Bio...plans to apply for a global phase 1 application for the hemophilia treatment 'TU7710' at the end of this year."

New P1 trial • Genetic Disorders • Hemophilia

TiumBio to transfer rare disease drug technologies to improve global health (Korea Biomedical Review) - "We currently have no plan for running clinical trials in Korea. If our IND application for the global phase 1 clinical trial wins approval by December, we might be able to begin administering the drug candidate to patients during the first three months of 2022. A global CDMO called Patheon in Australia is producing the drug materials. The number of people participating in the clinical trial will be around 20. We expect to see the test results in a short period."

New P1 trial • Genetic Disorders • Hemophilia

Tium Bio, which has invested 30 billion won in SK Plasma, "takes care of both growth potential and profits" [Google translation] (Money Today) - "In addition, Tium Bio plans to conduct global phase 1 clinical trials for 'TU7710', a hemophilia treatment, in the second half of this year."

New P1 trial • Genetic Disorders • Hemophilia

Tium Bio, develops a new drug to treat rare and intractable diseases [Google translation] (Hankyung) - "Tium Bio is producing clinical samples with the US Thermo Fisher Scientific Group, which has production facilities that meet FDA's pharmaceutical manufacturing and quality control standards, for clinical trials of 'TU7710', a new drug candidate for hemophilia bypass....The linker optimized for activated blood coagulation factor #7 and transferrin are being fused by genetic recombination."

Preclinical • Genetic Disorders • Hemophilia