81 FR 69066 - Prospective Grant of Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 193 (October 5, 2016)

Page Range		69066-69067
FR Document		2016-24030

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.

Federal Register, Volume 81 Issue 193 (Wednesday, October 5, 2016)

[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)]
[Notices]
[Pages 69066-69067]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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: [email protected]

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.


[[Page 69067]]


    Dated: September 29, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center. National Cancer 
Institute.
[FR Doc. 2016-24030 Filed 10-4-16; 8:45 am]
 BILLING CODE 4140-01-P

69066 Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Notices

TABLE 1—NEW DRAFT PRODUCT-SPE- of the applicable statutes and Antigen Receptors’’ [HHS Reference No.
CIFIC BE RECOMMENDATIONS FOR regulations. E–021–2015/0–PCT–02] (and U.S. and
DRUG PRODUCTS—Continued foreign patent applications claiming
IV. Electronic Access
priority to the aforementioned
Pyrazinamide Persons with access to the Internet applications).
Rolapitant hydrochloride may obtain the draft guidance at either
Triamcinolone acetonide (multiple reference The patent rights in these inventions
http://www.fda.gov/Drugs/Guidance
listed drugs) have been assigned to the government of
ComplianceRegulatoryInformation/
Umeclidinium bromide the United States of America.
Guidances/default.htm or http://
www.regulations.gov. The prospective Exclusive Patent
III. Drug Products for Which Revised License territory may be worldwide and
Draft Product-Specific BE Dated: September 30, 2016.
the field of use may be limited to the
Recommendations Are Available Leslie Kux,
development, manufacture and
Associate Commissioner for Policy. commercialization of retrovirally-
FDA is announcing the availability of [FR Doc. 2016–24050 Filed 10–4–16; 8:45 am] engineered anti-CD70 chimeric antigen
a revised draft guidance for industry on BILLING CODE 4164–01–P receptor (CAR)-based autologous
product-specific BE recommendations
peripheral blood T cell therapy
for drug products containing the
products, as set forth in the Licensed
following active ingredients: DEPARTMENT OF HEALTH AND Patent Rights, for the treatment of CD70
HUMAN SERVICES expressing cancers in humans.
TABLE 2—REVISED DRAFT PRODUCT-
SPECIFIC BE RECOMMENDATIONS National Institutes of Health The present invention describes
FOR DRUG PRODUCTS certain CARs targeting CD70. CARs are
Prospective Grant of Exclusive Patent hybrid proteins comprised of
Bacitracin
License: Development of Anti-CD70 extracellular antigen binding domains
Buprenorphine Chimeric Antigen Receptors for the and intracellular signaling domains
Clonidine Treatment of CD70 Expressing designed to activate the cytotoxic
Cyclosporine Cancers functions of CAR-transduced T cells
Dexlansoprazole upon antigen stimulation.
Diclofenac Epolamine AGENCY: National Institutes of Health,
Erythromycin HHS. CD70 is a co-stimulatory molecule
Estradiol (multiple reference listed drugs) ACTION: Notice. that provides proliferative and survival
Ethinyl Estradiol; Norelgestromin cues to competent cells upon binding to
Fentanyl SUMMARY: The National Cancer Institute, its cognate receptor, CD27. Its
Granisetron National Institutes of Health, expression is primarily restricted to
Icosapent ethyl Department of Health and Human activated lymphoid cells; however,
Lansoprazole Services, is contemplating the grant of recent research has demonstrated that
Lidocaine an Exclusive Patent License to Kite several cancers, including renal cell
Menthol; Methyl Salicylate
Pharma, Inc. (‘‘Kite’’) located in Santa carcinoma, glioblastoma, non-Hodgkin’s
Mesalamine
Methylphenidate Monica, CA to practice the inventions lymphoma, and chronic myelogenous
Morphine sulfate embodied in the patent applications leukemia also express CD70 under
Nicotine listed in the SUPPLEMENTARY certain circumstances. Due to its limited
Nitroglycerin (multiple reference listed drugs) INFORMATION section of this notice. expression in normal tissues, CARs
Omega-3-acid ethyl esters DATES: Only written comments and/or targeting CD70 may be useful in
Oxybutynin applications for a license which are adoptive cell therapy protocols for the
Oxycodone HCl treatment of select cancers.
received by the NCI Technology
Pantoprazole sodium
Rivastigmine Transfer Center on or before October 20, This notice is made in accordance
Rotigotine 2016 will be considered. with 35 U.S.C. 209 and 37 CFR part 404.
Scopolamine ADDRESSES: Requests for copies of the The prospective Exclusive Patent
Selegiline patent applications, inquiries, and License will be royalty bearing and may
Testosterone comments relating to the contemplated be granted unless within fifteen (15)
Exclusive Patent License should be days from the date of this published
For a complete history of previously directed to: Andrew Burke, Ph.D., notice, the National Cancer Institute
published Federal Register notices Licensing and Patenting Manager, NCI receives written evidence and argument
related to product-specific BE Technology Transfer Center, 9609 that establishes that the grant of the
recommendations, go to http:// Medical Center Drive, RM 1E530 MSC license would not be consistent with the
www.regulations.gov and enter Docket 9702, Bethesda, MD 20892–9702 (for requirements of 35 U.S.C. 209 and 37
No. FDA–2007–D–0369. business mail), Rockville, MD 20850– CFR part 404.
These draft guidances are being 9702 Telephone: (240) 276–5530; Complete applications for a license in
issued consistent with FDA’s good Facsimile: (240) 276–5504; Email: the prospective field of use that are
guidance practices regulation (21 CFR andy.burke@nih.gov timely filed in response to this notice
asabaliauskas on DSK3SPTVN1PROD with NOTICES

10.115). These draft guidances, when SUPPLEMENTARY INFORMATION: United will be treated as objections to the grant
finalized, will represent the current States Provisional Patent Application of the contemplated Exclusive Patent
thinking of FDA on the product-specific No. 62/088,882, filed December 8, 2014, License. Comments and objections
design of BE studies to support ANDAs. entitled ‘‘Anti-CD70 Chimeric Antigen submitted to this notice will not be
They do not establish any rights for any Receptors’’ [HHS Reference No. E–021– made available for public inspection
person and are not binding on FDA or 2015/0–US–01]; and PCT Application and, to the extent permitted by law, will
the public. You can use an alternative No. PCT/US2015/025047 filed April 9, not be released under the Freedom of
approach if it satisfies the requirements 2015 entitled ‘‘Anti-CD70 Chimeric Information Act, 5 U.S.C. 552.

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Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Notices 69067

Dated: September 29, 2016. DEPARTMENT OF HEALTH AND The meeting will be closed to the
Richard U. Rodriguez, HUMAN SERVICES public in accordance with the
Associate Director, Technology Transfer provisions set forth in sections
Center. National Cancer Institute. National Institutes of Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
[FR Doc. 2016–24030 Filed 10–4–16; 8:45 am] as amended. The grant applications and
Eunice Kennedy Shriver National the discussions could disclose
BILLING CODE 4140–01–P Institute of Child Health & Human confidential trade secrets or commercial
Development; Notice of Closed property such as patentable material,
Meeting and personal information concerning
DEPARTMENT OF HEALTH AND
Pursuant to section 10(d) of the individuals associated with the grant
HUMAN SERVICES
Federal Advisory Committee Act, as applications, the disclosure of which
National Institutes of Health amended (5 U.S.C. App.), notice is would constitute a clearly unwarranted
hereby given of the following meeting. invasion of personal privacy.
National Institute of Allergy and The meeting will be closed to the Name of Committee: National Institute of
Infectious Diseases; Notice of Closed public in accordance with the Allergy and Infectious Diseases Special
Meeting provisions set forth in sections Emphasis Panel; Cooperative Study Group
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., for Autoimmune Disease Prevention
as amended. The grant applications and (CSGADP).
Pursuant to section 10(d) of the Date: November 3–4, 2016.
Federal Advisory Committee Act, as the discussions could disclose Time: Time: 8:30 a.m. to 6:00 p.m.
amended (5 U.S.C. App.), notice is confidential trade secrets or commercial Agenda: To review and evaluate grant
hereby given of the following meeting. property such as patentable material, applications.
and personal information concerning Place: National Institutes of Health 4H100,
The meeting will be closed to the individuals associated with the grant 5601 Fishers Lane, Rockville, MD 20892.
public in accordance with the applications, the disclosure of which Contact Person: Thomas F. Conway, Ph.D.,
provisions set forth in sections would constitute a clearly unwarranted Scientific Review Officer, Scientific Review
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Program, Division of Extramural Activates,
invasion of personal privacy. Room 3G51, National Institutes of Health,
as amended. The grant applications and
Name of Committee: National Institute of NIAID, 5601 Fishers Lane, MSC 9823,
the discussions could disclose Child Health and Human Development Bethesda, MD 20892–9823, 240–507–9685,
confidential trade secrets or commercial Special Emphasis Panel. thomas.conway@nih.gov.
property such as patentable material, Date: November 9, 2016. (Catalogue of Federal Domestic Assistance
and personal information concerning Time: 2:00 p.m. to 4:00 p.m. Program Nos. 93.855, Allergy, Immunology,
individuals associated with the grant Agenda: To review and evaluate grant and Transplantation Research; 93.856,
applications. Microbiology and Infectious Diseases
applications, the disclosure of which
Place: National Institute of Health, 6710 B, Research, National Institutes of Health, HHS)
would constitute a clearly unwarranted Rm 2133, Rockledge Drive, Bethesda, MD
invasion of personal privacy. 20892, (Telephone Conference Call). Dated: September 29, 2016.
Contact Person: Joanna Kubler-Kielb, Natasha M. Copeland,
Name of Committee: National Institute of
Scientific Review Officer, Scientific Review Program Analyst, Office of Federal Advisory
Allergy and Infectious Diseases Special
Branch, Eunice Kennedy Shriver National Committee Policy.
Emphasis Panel; Consortium for Food Institute of Child Health and Human
Allergy Research: Leadership Center (UM2). [FR Doc. 2016–24025 Filed 10–4–16; 8:45 am]
Development, 6710B Bethesda Drive,
Date: November 16–18, 2016. BILLING CODE 4140–01–P
Bethesda, MD 20892, 301–435–6916, kielbj@
Time: 7:30 p.m. to 6:00 p.m. mail.nih.gov.
Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance
applications. Program Nos. 93.864, Population Research; DEPARTMENT OF HEALTH AND
Place: The William F. Bolger Center, 9600 93.865, Research for Mothers and Children; HUMAN SERVICES
Newbridge Drive, Potomac, MD 20854. 93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and National Institutes of Health
Contact Person: Andrea L. Wurster, Ph.D.,
Scientific Review Officer, Scientific Review Infertility Loan Repayment Program, National
Institutes of Health, HHS) Center for Scientific Review; Notice of
Program, Division of Extramural Activities, Closed Meeting
Room 3G33B, National Institutes of Health, Dated: September 29, 2016.
NIAID, 5601 Fishers Lane, MSC 9823, Michelle Trout, Pursuant to section 10(d) of the
Bethesda, MD 20899823, (240) 669–5062, Program Analyst, Office of Federal Advisory Federal Advisory Committee Act, as
wurstera@mail.nih.gov. Committee Policy. amended (5 U.S.C. App.), notice is
(Catalogue of Federal Domestic Assistance [FR Doc. 2016–24027 Filed 10–4–16; 8:45 am] hereby given of the following meeting.
Program Nos. 93.855, Allergy, Immunology, BILLING CODE 4140–01–P The meeting will be closed to the
and Transplantation Research; 93.856, public in accordance with the
Microbiology and Infectious Diseases provisions set forth in sections
Research, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
HUMAN SERVICES as amended. The contract proposals and
Dated: September 29, 2016. the discussions could disclose
Natasha M. Copeland, National Institutes of Health confidential trade secrets or commercial
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Program Analyst, Office of Federal Advisory property such as patentable material,
Committee Policy. National Institute of Allergy and and personal information concerning
[FR Doc. 2016–24026 Filed 10–4–16; 8:45 am]
Infectious Diseases; Notice of Closed individuals associated with the contract
Meeting proposals, the disclosure of which
BILLING CODE 4140–01–P
Pursuant to section 10(d) of the would constitute a clearly unwarranted
Federal Advisory Committee Act, as invasion of personal privacy.
amended (5 U.S.C. App.), notice is Name of Committee: Center for Scientific
hereby given of the following meeting. Review Special Emphasis Panel; RFA–AI–

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Document Created: 2016-10-05 03:28:44
Document Modified: 2016-10-05 03:28:44

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		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.
FR Citation		81 FR 69066

81 FR 69066 - Prospective Grant of Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 193 (October 5, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health