On June 28, 2017 Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy company, reported that the United States Patent and Trademark Office (USPTO) has provided a Notice of Intent to issue an Ex Parte Reexamination Certificate that confirms the patentability of amended claims presented in U.S. Patent No. 7,741,465, known as the Eshhar ‘465 patent (Press release, Kite Pharma, JUN 28, 2017, View Source [SID1234519709]). The Eshhar ‘465 patent, exclusively licensed by Kite in 2013, protects the axicabtagene ciloleucel franchise and may impact competitive CAR-T therapies. Schedule your 30 min Free 1stOncology Demo! "This notice by the USPTO outlining its intent to confirm the Eshhar patent further asserts the pioneering role of Dr. Zelig Eshhar in developing CAR-T technology," said Arie Belldegrun, MD, FACS, Chairman, President and Chief Executive Officer of Kite. "Our significant patent portfolio, combined with our positive data and industry-leading manufacturing process, reinforces our position as one of the foremost companies in cell therapy."
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The Eshhar ‘465 patent term continues to June 2027, not including certain potential extensions. Kite’s growing intellectual property portfolio now encompasses more than 200 patent assets relating to its broad cell therapy pipeline and manufacturing excellence.
Axicabtagene ciloleucel is the first engineered cell therapy to be reviewed by the U.S. Food and Drug Administration (FDA) in aggressive non-Hodgkin’s lymphoma (NHL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2017.
About axicabtagene ciloleucel
Kite’s lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.