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KDDF-201812-07 Study for the process development and indication expansion of an anti-fibrotic antibody(Cardiovascular Diseases, Protein) [2019-11-26]

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

Development and Market Objectives

KRS (lysyl-tRNA synesthetase) has been shown to be important in the migration of monocytes and macrophages and critical for the pathogenesis of pulmonary arterial hypertension (PAH). We have identified a candidate antibody that modulates KRS-dependent immune cell migration and shows promise as a therapeutic in the prevention of progression of PAH progression in animal studies. The objective of this study is to confirm the efficacy of the candidate antibody and to develop an antibody-producing stable cell line for further pre-clinical evaluation.

Unmet Medical Need & Target Patients

PAH is a rare disease characterized by high blood pressure and fibrosis of pulmonary arteries and is caused by chronic inflammation around injured pulmonary arteries. The resulting right heart failure is the main cause leading to PAH patient deaths with 3 year survival rates after diagnosis of about 50%. Commercially available therapies are currently palliative and act to reduce blood pressure by dilating blood vessels. Therefore, there is a high unmet medical need for the therapies which can increase survival rate and remove the pathophysiological cause of PAH with low side effects.

Status

KRS is located on the plasma membrane of monocytes and macrophages and modulates their migration to damaged tissue. Our lead novel human antibody binds to a region of KRS that is exposed on the cell surface and shows significant improvement in various PAH measurements, e.g. right ventricular end-systolic pressure, monocytes and macrophages infiltration to the lung, and fibrosis in multiple PAH rat models. Moreover, our lead antibody increased animal survival and showed a synergic effect when combined with sildenafil, the current standard of care vasodilation therapy.   

Further studies on the mode of action (MOA) of our antibody are underway, together with development of analytical process to support progression toward a clinical study. Among these studies is the confirmation of in vivo efficacy of the candidate antibody as well as preliminary toxicology and clinical validation studies. In addition, we will develop an antibody-producing stable cell line to support additional preclinical studies.

Intellectual Property

Application for domestic and PCT patents have been filed for both composition of matter and uses of KRS antibodies.

Competitive Advantages

This antibody is a first-in-class therapeutic with novel MOA, which can eliminate the root pathologic cause of PAH. Our antibody specifically controls inflammation and limits fibrosis in a pathologic condition. Since existing therapies have significant side effects, we expect our approach to be superior and improve both the quality and longevity of life for affected patients. For example, the antibody does not induce systemic hypotension which is frequently observed in the case of other treatments, therefore, it can be considered as an early treatment option for PAH patients with systemic hypotension. Lastly, this work will also enable additional studies on the use of the antibody in other important fibrotic disease.

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