Kyowa Granted Approval For Additional Indication For Mogamulizumab

Kyowa Hakko Kirin President and CEO Nobuo Hanai announced that the company has received approval for the additional indication for Mogamulizumab from the Japanese Ministry of Health, Labour, and Welfare (MHLW).

Mogamulizumab is currently indicated for the treatment of patients with relapsed or refractory CCR4-positive ATL. The MHLW approved the drug marketed under the brand name Poteligeo injection for the additional indication for relapsed or refractory CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).

The drug is a new, humanized monoclonal antibody designed to target CC chemokine receptor 4, which is often observed to be over-expressed on different malignant T cells including PTCL and CTCL cells. The antibody is directed against target cells through effective antibody dependent cellular cytotoxicity (ADCC).

CCR4 is a chemokine receptor involved in leukocyte migration, selectively expressed in type 2 helper cells and regulatory cells. The receptor is known to be over expressed in specific hematological malignancies. PTCL is an umbrella term for nodal and extranodal disease of T/NK cell origin such as malignant lymphoma cases. Diseases rooted from T/NK cell origins are classified according to main lesion site into leukemic, cutaneous, nodal, and extranodal disease. CTCL is a rare, low grade type of non-Hodgkin’s lymphoma, the two most common types of which are mycosis fungoides (MF) and Sezary syndrome (SS). The disease may manifest as skin patches, plaques, or tumors. It also includes the presence of malignant lymphocytes in the blood.

ADCC is a main immune response of the body initiated by binding of an antibody to its antigen on target cells. This is followed by lysis of the antibody bound target cells by effector cells like natural killer cells. ADCC is one of the modes of action of therapeutic antibodies.

Potelligent is Kyowa Hakko Kirin’s technology used to produce antibodies with enhanced ADCC activity such as mogamulizumab. The technology allows for the production of antibodies with a reduced amount of fucose in their carbohydrate structure. Antibodies produced in this manner are shown to have greater efficiency in destroying target cells than conventional antibodies.

The company also received orphan drug designation for the treatment of PTCL and CTCL in March 2013 from the MHLW, which is only given to drugs addressing high medical needs and which possess high possibility for development.