[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Page 23737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09324]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of Anti-
CD70 Chimeric Antigen Receptors (CARs) for the Treatment of Chronic 
Myelogenous Leukemia

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Cancer Institute, National Institutes of 
Health, Department of Health and Human Services, is contemplating the 
grant of an exclusive patent license to Dedalus Pharma, LLC 
(``Dedalus'') located in Maryland, USA.

Intellectual Property

    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].
    The patent rights in these inventions have been assigned to the 
government of the United States of America.
    The patent rights in these inventions have been assigned to the 
government of the United States of America. The prospective exclusive 
license territory may be worldwide and the field of use may be limited 
to the development and commercialization of 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 chronic myelogenous leukemia in humans.

DATES: Only written comments and/or applications for a license which 
are received by the Technology Transfer Center at the National Cancer 
Institute on or before May 9, 2016 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Andrew Burke, Ph.D., Licensing and Patenting Manager, 
Technology Transfer Center, National Cancer Institute, 9609 Medical 
Center Drive, MSC 9702, Rockville, MD 20852; Telephone: (240) 276-5484; 
Email: [email protected].

SUPPLEMENTARY INFORMATION: The present invention describes chimeric 
antigen receptors (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.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 
404. The prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the NCI 
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 an appropriate field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive 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.

     Dated: April 18, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-09324 Filed 4-21-16; 8:45 am]
 BILLING CODE 4140-01-P