ISU304(Dalcinonacog alfa, DalcA) is a modified recombinant Factor IX protein for the prophylactic therapy of patients with Hemophilia B which is caused by a deficiency of coagulation FIX. It is designed to be administered subcutaneously and achieves normal FIX activity levels to prevent bleeding of patients with hemophilia B. Currently approved protein replacement therapy for hemophilia B rely on intravenous injection. With a subcutaneous injection, ISU304 is expected to improve the quality of life and treatment convenience in patients with hemophilia B. The Phase 2 clinical trial is completed by the company’s partner, Catalyst Biosciences, and confirmed the safety and efficacy of ISU304 in patients with severe hemophilia B. For more details on clinical study of ISU304, please visit the Catalyst Biosciences’s Website.
(Page links to Catalyst Biosciences)
Clinical Studies
Phase 2b, single-center, open-label study designed to evaluate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneous (SC) prophylaxis treatment regimens with CB2679d in 6 adult, male subjects with severe congenital hemophilia B.
NCT03995784; Sponsored by Catalyst Biosciences
A Phase 1, Open-label, Multi-center, Dose-escalation Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of ISU304 in Previously Treated Hemophilia B Patients. NCT03186677; Sponsored by ISU ABXIS
ISU305(Eculizumab) is a biosimilar of Soliris® developed by Alexion Pharmaceuticals, Inc. It is a monoclonal antibody therapy for PNH (Paroxysmal Nocturnal Hemoglobinuria) that specifically binds to a complement protein C5 and inhibits the production of terminal complement C5b-9 by blocking the division of C5a and C5b. We completed the Phase 1 clinical trial and confirmed bioequivalence, safety, and tolerability profile of ISU305 compared to reference product Soliris® in healthy volunteers.
Clinical Studies
A randomised, double-blind, single-dose study to evaluate the pharmacokinetic, safety, tolerability, immunogenicity and pharmacodynamic profile of ISU305 compared to Soliris® (Eculizumab) in Healthy Male Volunteers. ACTRN12619000694112
ISU203 is a novel monoclonal anti-ASM antibody for the treatment of Alzheimer’s disease. It inhibits ASM(Acid Sphingomyelinase)* activity and regulates neuroinflammation, resulting in indirectly inhibition of amyloid-beta aggregation in the brains.
* ASM (Acid Sphingomyelinase): An enzyme over-expressed in the elders that causes the damages in cerebrovascular and cranial nerve systems; also, over-expressed in the blood of patients with Alzheimer's disease
ISU104(Barecetamab) is a novel human monoclonal anti-ErbB3 antibody that inhibits the growth of cancer cells by targeting ErbB3 protein on the cell membrane. It inhibits the binding of ErbB3 with its ligands HRG(heregulin) or NRG-1 (neuregulin-1) and blocks the dimerization of ErbB3 with either EGFR or ErbB2, resulting in inhibition of the cancer growth. ErbB3 is noted as one of major causes of acquired drug resistance limiting the successful treatment of cancer. Currently, there is no approved therapy targeting ErbB3 to treat cancer. ISU104 is expected to be a treatment option in cancers that have developed resistance to standard therapies. We completed the Phase 1 clinical trial and confirmed the safety and efficacy of ISU104 in patients with advanced solid tumors and recurrent/metastatic HNSCC(Head and Neck Squamous Cell Carcinoma) refractory to standard therapies.
Clinical Studies
A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability and Pharmacokinetics of ISU104, a Human Monoclonal Antibody Targeting ErbB3 in Patients With Advanced Solid Tumors.
NCT03552406
ISU104-CAR-NK is a novel anti-cancer immune cell therapy that combines ISU104, an anti-ErbB3 mAb, with CAR-NK* technology. While CAR-T therapy is a syngeneic cell therapy customized to the individual patient, CAR-NK therapy can be applied to any allogeneic patients.
* CAR-NK (Chimeric Antigen Receptor expressing Natural Killer cells): a platform technology that CAR(Chimeric Antigen Receptor) recognizes a tumor-specific antigen and NK(Natural Killer) cells kill cancer cells
ABX2001 is an novel cancer immunotherapy that uses Probody* technology. It induces tumor regression and anti-tumor immunostimulatory activity once pro-cytokines are changed into active cytokines by protease in the tumor microenvironment.
* Probody: a platform technology that pro-cytokine is activated as an active form only by tumor-specific protease in the tumor microenvironment
