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KDDF-201206-04 Developing an autoimmune disease treatment antibody with a novel effector mechanism(Immunology, Protein) [2015-07-07]

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

Development and Market Objectives

Various autoimmune diseases are characterized by the involvement of pathogenic autoantibodies in pathogenesis.
We are developing a novel anti-FcRn antibody that suppresses autoimmunity against autoantigens through dual modes of action: increasing catabolism of pathogenic autoantibodies and decreasing antigen presentation with MHC class I and II by blocking FcRn, thereby exerting a therapeutic effect on various autoimmune diseases such as Pemphigus Vulgaris, Neuromyelitis Optica, Myasthenia Gravis and Lupus Nephritis.

Unmet Medical Need & Target Patients

1) Target patient 

• Pemphigus Vulgaris is a disease in which epithelial blisters and inflammation form on the skin or mucous membranes by destroying connections between epidermal cells when autoantibodies combine with desmoglein to connect epidermal cell (Keratinocytes) proteins, causing death by a secondary decrease of body fluids and infections through the formation of blisters. It occurs annually in approximately 1~32 people per million, increasing by as much as 11% annually, and has a reported death rate of about 5%. 

• Neuromyelitis optica is a disease causing permanent blindness, waist-down paralysis, and even death resulting from respiratory failure induced by autoantibodies related to aquaporin-4 of astrocytes in the nervous system. Its prevalence rate is reported as ranging from 3~30 people per million. 

• Myasthenia Gravis is a disease in which the acetylcholine receptors are destroyed by autoantibodies followed by muscle contraction starting from the eyeball, which extends to the whole body, and can sometimes lead to death by respiratory failure. The prevalence rate is approximately 200 people per million, with the annual rate reported as 3~30 people per million.

2) Unmet Medical Needs

•Systemic corticosteroid is a mainstay of the current treatment option for the patients with autoimmune diseases. If the patients don’t respond to this drug, high dose of IVIG therapy and plasmapheresis are used. However, current treatment options have significant limitations in terms of efficacy, safety and  treatment cost. So, the development of a new treatment option is urgently required.
• Systemic corticosteroids and other immunosuppressive agents are limited in terms of efficacy and long-term safety.  High dose IVIG therapy requires a high treatment cost (10,000~20,000$ per cycle) and hospitalization of the patients for IV infusion. These are the major unmet needs in Autoimmune diseases.
 
 
[Medical Unmet Needs in the area of Serious Autoimmune Disease]

Status

Optimization of the lead antibody is proceeding.

Intellectual Property

We have applied for a material patent related to the lead antibody.

Competitive Advantages

•There are concerns over an imbalance between supply and demand of plasma-derived product, IVIG, due to an increased demand for plasma. However, this supply and demand issues for our anti-FcRn monoclonal antibody will be stable because it will be produced  by using recombinant mammalian cell.
 
• In the case of IVIG, the price for a single treatment reaches $10,000~20,000 with  standard dosage of 1~2g/kg, but  the treatment cost of our  anti-FcRn monoclonal antibody  will be significantly lower than IVIG since it will be effective at 10~20mg/kg in the patients.
 
• Anti-FcRn antibody can effectively suppresses autoimmunity against autoantigens through increasing catabolism of pathogenic autoantibodies and decreasing antigen presentation  by blocking FcRn, thus exert therapeutic effect on various autoimmune diseases.

Contact & Company Overview

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