Kite Pharma, Inc. KITE announced that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has adopted positive opinions in favor of granting orphan drug status to the company’s lead pipeline candidate, KTE-C19, for the treatment of three additional indications – acute lymphoblastic leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma and follicular lymphoma (FL).
We note that KTE-C19 already has orphan drug designation in both the U.S. and EU for the treatment of diffuse large B-cell lymphoma (DLBCL). We remind investors that KTE-C19 received positive opinions from the COMP for orphan drug status for the treatment of two indications last month – primary mediastinal B-cell lymphoma (PMBCL) and mantle cell lymphoma.
The European Commission usually grants orphan drug status to treatments for life-threatening or chronically debilitating conditions affecting no more than five in 10,000 people and for which no satisfactory treatment is available. In addition to providing companies with regulatory (seeking protocol assistance from the EMA during the product development phase and direct access to the centralized authorization procedure) and financial incentives, orphan drug status in the EU comes with a 10-year period of marketing exclusivity upon approval.
KTE-C19, an anti-CD19 chimeric antigen receptor (CAR) T cell therapy, is in a phase I/II study (ZUMA-1) in patients with refractory, aggressive non-Hodgkin's lymphoma including DLBCL, PMBCL and transformed FL. Top-line data from the phase I part of the study is expected later this year.
We note that Kite is looking to revolutionize cancer treatments by engaging the body’s own immune system to treat cancer. The company has collaboration agreements with Amgen AMGN and bluebird bio, Inc. BLUE.
Meanwhile, the development of CAR T cell therapies has been attracting a lot of attention lately with several companies eyeing this field. Juno Therapeutics JUNO is also working on developing therapies utilizing CAR T cell technology.
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