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KDDF-201410-02 Development of New Antibody Therapeutics of Novel Mechanismfor the Treatment of Severe Autoimmune Diseases(Immunology, Protein) [03.04.2015]

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Development and Market Objectives

The final objective of this project is to develop a novel antibody drug for the treatment of various autoimmune diseases mainly caused by autoantibodies. 
The antibody candidates presenting excellent efficacy were selected and we are preparing the nonclinical toxicity study and Phase 1 study.

Unmet Medical Need & Target Patients

The first target indications are pathogenic IgG-mediated autoimmune diseases like pemphigus vulgaris, neuromyelitis optica and myasthenia gravis. In addition, immune complex-mediated glomerular diseases like lupus nephritis and membraneous nephropathy could be applied.

 

There is no specific medicine for these indications. In the case of pathogenic IgG-mediated autoimmune diseases, high dose of steroid, high dose of IVIG therapy and plasmapheresis are current treatment option for the patients. 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. 

Status

Two fully human anti-FcRn candidate antibodies were selected from human immunoglobulin transgenic rats 

 

Candidate antibodies, HL161A and HL161B, have high affinity to hFcRn and blocking effect against IgG:FcRn interaction 

 

Fc-engineering was conducted to eliminate additional effect functions such as ADCC and CDC, and HL161AN and HL161BKN, Fc-engineered antibodies of HL161A and HL161B, were constructed

 

Both of HL161AN and HL161BKN are able to reduce IgG levels up to about 80% in cynomolgus monkeys 

Investigational New Drug (IND) for first-in-human study will be filed at Mar. 2017

Intellectual Property

• 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 HL161 anti-FcRn monoclonal antibody will be stable because it will be produced by recombinant technology.

• 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 HL161 will be significantly lower than IVIG since it will be effective at 10~20mg/kg in the patients.

• HL161 can effectively suppresses autoimmunity against autoantigens through increasing catabolism of pathogenic autoantibodies, thus exert therapeutic effect on various severe autoimmune diseases.

• HL161 shows excellent efficacy in comparison with IVIG and anti-FcRn antibodies that other companies are developing.

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 HL161 anti-FcRn monoclonal antibody will be stable because it will be produced by recombinant technology.

 

• 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 HL161 will be significantly lower than IVIG since it will be effective at 10~20mg/kg in the patients.

 

• HL161 can effectively suppresses autoimmunity against autoantigens through increasing catabolism of pathogenic autoantibodies, thus exert therapeutic effect on various severe autoimmune diseases.

 

• HL161 shows excellent efficacy in comparison with IVIG and anti-FcRn antibodies that other companies are developing.

Indication

Immunology

Research Period

2015.2.1-2017.6.30

Company

HanAll BioPharma Co.,Ltd.

Developmental Stage

Optimization

Additional Information

Contact Information

Contact
Address Company Name: HanAll BioPharma Co.,Ltd.
WebSite Homepage: http://www.hanall.co.kr Contact Person: Hyeakyung Ahn
E-mail: ahnhk@hanall.co.kr Contact: 82-31-888-6529

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