Kite Pharma, Inc. announced that it has entered into a collaboration agreement with Roche Holding’s (RHHBY - Free Report) Genentech for its immunotherapy candidate, KTE-C19.
Per the terms of the agreement, the companies will collaborate to evaluate the safety and efficacy of Kite’s KTE-C19, in combination with Roche’s immunotherapy, atezolizumab (also known as MPDL3280A), in patients suffering from refractory, aggressive non-Hodgkin lymphoma (NHL), with Kite acting as the sponsor of the study.
We note that KTE-C19 is already being evaluated in four pivotal studies (collectively known as ZUMA) in patients with various B cell malignancies. The FDA granted Breakthrough Therapy Designation to KTE-C19 for the treatment of patients with refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL). The candidate also enjoys orphan drug Status for DLBCL in the U.S. and various hematological indications in the EU. Earlier this week, the FDA granted priority review to atezolizumab for advanced bladder cancer.
KTE-C19 works by genetically modifying a patient's T cells to express a CAR designed to target the antigen CD19, a protein which is expressed on the cell surface of B cell lymphomas and leukemias. On the other hand, atezolizumab is a monoclonal antibody that targets and binds to a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells. Since PD-L1 interacts with PD-1 and B7.1, both of which are found on the surface of T cells and cause inhibition of T cells, the combination of KTE-CI9 and atezolizumab could provide a synergistic effect to patients.
Kite and Roche expect to initiate a phase Ib/II study on the combination later in 2016, using the same dose and regimen of KTE-C19 as that in Kite’s current ongoing, potential registration study (ZUMA-1) in patients with refractory, aggressive NHL. Results from this study will determine prospects of development of the combination.
We remind investors that Kite has a collaboration agreement with Amgen, Inc. (AMGN - Free Report) for the development and commercialization of next-generation novel CAR T cell immunotherapies based on Kite's eACT platform and Amgen's extensive array of cancer targets.
Kite currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Actelion Ltd. with a Zacks Rank #1 (Strong Buy).
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