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KDDF-201606-02 Development of long-acting conjugation factor VIIa fusion proteins by next generation of NexPTM technology(Hematological Diseases, Protein) [2019-03-18]

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Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

Development and Market Objectives

Development of best-in-class long-acting coagulation factor VIIa candidates based on next generation of NexPTM technology that maintain biological activity and exhibit prolonged half-life in vivo through 1) establishment of stable cell lines 2) optimization of cell culture processes 3) establishment of purification processes

Unmet Medical Need & Target Patients

Target patients: patients with hemophilia A or B with inhibitors to factor VIII or factor IX that need commercially-available factor VIIa treatment

Unmet medical need

- Short in vivo half-life: ~2 hours in human (NovoSeven®)

- High frequency of use for the patients (NovoSeven®)

- No approved drug for prophylactic treatment

Status

We have acquired the technology for efficient gamma-carboxylation and activation as well as high productivity, which are crucial for development of recombinant factor VIIa.

- 7 times increase of half-life compared to NovoSeven® (in rats)

- Coagulation activity comparable to NovoSeven® (in rats)

- Development of FVIIa-NexP with next generation of NexP technology

Intellectual Property

- Two patent applications on the platform technology of NexP: submitted for 13 countries, registered in 9 countries including US and Europe  

- Korean patents and PCT applications in preparation.

Competitive Advantages

- No approved long-acting recombinant FVIIa: only three candidates are under clinical trials

- Higher half-life of FVIIa-NexP over albumin- or CTP-fusion FVIIa (in rats)

- Better long-acting coagulation property of FVIIa-NexP than FVIIa-CTP fusion.

- Significantly improved productivity in culture and purification process

Contact & Company Overview

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