EC Designates Innate's CTCL Antibody As Orphan Drug
Innate Pharma, a biopharmaceutical company developing innate immunity drug candidates, announced that the European Commission has awarded Orphan Medicinal Product Designation to its antibody IPH4102 for the treatment of cutaneous T-cell lymphoma (CTCL).
IPH4102 is a first-in-class cytotoxic anti-KIR3DL2 antibody, designed to attack and destroy CTCL cancer cells, especially in the most aggressive forms, including Sezary Syndrome and Transformed Mycosis Fungoides. The antibody targets the inhibitory receptor KIR3DL2, commonly expressed in most subtypes of CTCL. Biomarker mAb tools for the monitoring of KIR3DL2 expression are also being developed in parallel to the antibody. Last year, the company launched investigational new drug (IND)-enabling studies for IPH4102, which it expects to file later this year.
Hervé Brailly, co-founder and CEO 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.” The company said the Phase I trial of IPH4102 is scheduled to start in 2015.
Cutaneous T-cell lymphoma is a heterogenous group of rare non-Hodgkin’s lymphomas manifested in the infiltration of malignant T cells in the skin. Patients with CTCL have poor prognosis and those who are at advanced stages (median survival of less than 5 years) have limited therapeutic options. CTCL affects 4 percent of all cases of non-Hodgkin’s lymphoma, with annual combined cases in the U.S. and EU estimated between 5,000 and 6,000.
Orphan Medicinal Product Designation in the EU incentivizes the development of drugs and therapies that address rare, life-threatening disease, such as CTCL. Once approved, an orphan drug gets 10 years of market exclusivity, along with a range of benefits including possible exemption in regulatory fees and protocol assistance.
Last month the company also announced the completion of its target enrollment in the Phase II trial of its investigational drug lirilumab as maintenance treatment for aged patients with Acute Myeloid Leukemia (AML) in first complete remission. The drug is licensed to Bristol-Myers Squibb and is also undergoing development in other indications.