Prospective Grant of Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

The National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Kite Pharma, Inc. (“Kite”) located in Santa Monica, CA to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.

DATES:

Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before October 20, 2016 will be considered.

ADDRESSES:

Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Andrew Burke, Ph.D., Licensing and Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-9702 Telephone: (240) 276-5530; Facsimile: (240) 276-5504; Email: andy.burke@nih.gov

SUPPLEMENTARY INFORMATION:

United States Provisional Patent Application No. 62/088,882, filed December 8, 2014, entitled “Anti-CD70 Chimeric Antigen Receptors” [HHS Reference No. E-021-2015/0-US-01]; and PCT Application No. PCT/US2015/025047 filed April 9, 2015 entitled “Anti-CD70 Chimeric Antigen Receptors” [HHS Reference No. E-021-2015/0-PCT-02] (and U.S. and foreign patent applications claiming priority to the aforementioned applications).

The patent rights in these inventions have been assigned to the government of the United States of America.

The prospective Exclusive Patent License territory may be worldwide and the field of use may be limited to the development, manufacture and commercialization of retrovirally-engineered anti-CD70 chimeric antigen receptor (CAR)-based autologous peripheral blood T cell therapy products, as set forth in the Licensed Patent Rights, for the treatment of CD70 expressing cancers in humans.

The present invention describes certain CARs targeting CD70. CARs are hybrid proteins comprised of extracellular antigen binding domains and intracellular signaling domains designed to activate the cytotoxic functions of CAR-transduced T cells upon antigen stimulation.

CD70 is a co-stimulatory molecule that provides proliferative and survival cues to competent cells upon binding to its cognate receptor, CD27. Its expression is primarily restricted to activated lymphoid cells; however, recent research has demonstrated that several cancers, including renal cell carcinoma, glioblastoma, non-Hodgkin's lymphoma, and chronic myelogenous leukemia also express CD70 under certain circumstances. Due to its limited expression in normal tissues, CARs targeting CD70 may be useful in adoptive cell therapy protocols for the treatment of select cancers.

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective Exclusive Patent License will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.