Innate Pharma SA, the innate immunity company developing first-in-class drug candidates for cancer and inflammatory diseases, announced that the European Commission has granted orphan drug designation to IPH4102 for the treatment of cutaneous T-cell lymphoma (CTCL).
CTCL is a group of rare cutaneous lymphomas of T lymphocytes with poor prognosis and few therapeutic options at advanced stages. IPH4102 is a first-in-class cytotoxic anti-KIR3DL2 antibody, aiming at destroying CTCL cancer cells.
Hervé Brailly, chief executive officer and co-founder of Innate Pharma, said: “This decision by the European Commission validates the IPH4102 approach in a disease with significant medical need and supports our strategy for a rapid clinical development”.
Phase I trial with IPH4102 is expected to begin in 2015. Cutaneous T-Cell Lymphomas (CTCL) are a heterogeneous group of non-Hodgkin’s lymphomas characterised by infiltration of the skin by malign ant T-cells. According to the Leukemia & Lymphoma Society, CTCL account for ca. 4 per cent of all NH L. The number of new cases of CTCL in US and EU (combined) annually is estimated to be 5,000 to 6,000.
CTCL is a life-threatening condition in its advanced stages with median survival of less than five years. Its treatment depends on the specific type of tumour, its stage and the extent of lesions.
Patients with limited stage disease are effectively treated with topical therapies. If these are ineffective or if the patient develops advanced stage disease then systemic therapies are introduced. In advanced stage disease, responses are often partial and seldom durable and there is no treatment for which improved survival has been demonstrated.140827 Orphan drug designation IP
EMA's Orphan Medicinal Product Designation is designed to promote the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases. In addition to 10 years of market exclusivity in case of approval, the designation also provides special incentives for sponsors including eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees during development or at the time of application for marketing approval.
Innate Pharma S.A. is a biopharmaceutical company conducting research and development of innovative immunotherapy drug candidates for cancer and inflammatory diseases.