80 FR 36828 - Prospective Grant of Exclusive License: The Development of an Anti-CD19 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancers

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 123 (June 26, 2015)

Page Range		36828-36829
FR Document		2015-15657

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Patent Application 62/006,313 entitled ``Chimeric Antigen Receptors Targeting CD-19'' [HHS Ref. E-042-2014/0-US-01], and all related continuing and foreign patents/patent applications for the technology family, to Kite Pharma, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive licensed territory may be worldwide, and the field of use may be limited to: ``All prophylactic and therapeutic uses for CD19-associated diseases, states and conditions in humans.''

Federal Register, Volume 80 Issue 123 (Friday, June 26, 2015)

[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36828-36829]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of an 
Anti-CD19 Chimeric Antigen Receptor (CAR) for the Treatment of Human 
Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an exclusive license 
to practice the inventions embodied in U.S. Provisional Patent 
Application 62/006,313 entitled ``Chimeric Antigen Receptors Targeting 
CD-19'' [HHS Ref. E-042-2014/0-US-01], and all related continuing and 
foreign patents/patent applications for the technology family, to Kite 
Pharma, Inc. The patent rights in these inventions have been assigned 
to and/or exclusively licensed to the Government of the United States 
of America.
    The prospective exclusive licensed territory may be worldwide, and 
the field of use may be limited to: ``All prophylactic and therapeutic 
uses for

[[Page 36829]]

CD19-associated diseases, states and conditions in humans.''

DATES: Only applications for a license which are received by the NIH 
Office of Technology Transfer on or before July 27, 2015 will be 
considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: David A. Lambertson, Ph.D., Senior 
Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301) 
402-0220; Email: [email protected].

SUPPLEMENTARY INFORMATION: This invention concerns an anti-CD19 
chimeric antigen receptor (CAR) and methods of using the CAR for the 
treatment of CD19-expressing cancers, including B cell malignancies.
    CD19 is a cell surface antigen that is preferentially expressed on 
certain types of cancer cells, particularly cancers of B cell origin 
such as Non-Hodgkin's Leukemia (NHL), acute lymphoblastic leukemia 
(ALL) and chronic lymphocytic leukemia (CLL). The anti-CD19 CARs of 
this technology contain (1) antigen recognition sequences that bind 
specifically to CD19 and (2) signaling domains that can activate the 
cytotoxic functions of a T cell. The anti-CD19 CAR can be transduced 
into T cells that are harvested from a cancer patient; from there, T 
cells expressing the anti-CD19 CAR are selected, expanded and then be 
reintroduced into the patient. Once the anti-CD19 CAR-expressing T 
cells are reintroduced into the patient, the T cells can selectively 
bind to CD19-expressing cancer cells through its antigen recognition 
sequences, thereby activating the T cell through its signaling domains 
to selectively kill the cancer cells. Through this mechanism of action, 
the selectivity of the a CAR allows the T cells to kill cancer cells 
while leaving healthy, essential cells unharmed. This can result in an 
effective therapeutic strategy with fewer side effects due to less non-
specific killing of cells.
    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 the NIH 
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 within thirty (30) days from the date of 
this published notice.
    Complete applications for a license in an appropriate field of use 
that are 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: June 22, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-15657 Filed 6-25-15; 8:45 am]
 BILLING CODE 4140-01-P

36828 Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices

Panel Review of R25 Research Training Grant [HHS Ref. E–039–2011/0–CA–04]; cells. Moreover, as these antibodies
Applications. European Patent Application No. selectively target ROR1, they can also be
Date: July 17, 2015. 11791733.6 entitled, ‘‘Chimeric rabbit/ used to diagnose B-cell malignancies.
Time: 8:30 a.m. to 5:00 p.m. human ROR1 antibodies’’ filed The prospective exclusive license will
Agenda: To review and evaluate grant
November 30, 2011 [HHS Ref. E–039– comply with the terms and conditions
applications.
Place: Courtyard by Marriott Chevy Chase, 2011/0–EP–05]; and U.S. Patent of 35 U.S.C. 209 and 37 CFR part 404.
5520 Wisconsin Avenue, Chevy Chase, MD Application No. 13/990,977 entitled, The exclusive license may be granted
20815 ‘‘Chimeric rabbit/human ROR1 unless within thirty (30) days from the
Contact Person: Lisa A. Dunbar, Ph.D., antibodies’’ filed May 31, 2013 [HHS date of this published notice, the NIH
Scientific Review Officer, Office of Scientific Ref. E–039–2011/0–US–06] and all receives written evidence and argument
Review, National Institute of General Medical related continuing and foreign patents/ that establishes that the grant of the
Sciences, National Institutes of Health, 45 patent applications for the technology license would not be consistent with the
Center Drive, Room 3An.12F, Bethesda, MD family to Emergent BioSolutions. The requirements of 35 U.S.C. 209 and 37
20892, 301–594–2849, dunbarl@mail.nih.gov.
patent rights in these inventions have CFR part 404.
(Catalogue of Federal Domestic Assistance been assigned to the Government of the Any additional, properly filed, and
Program Nos. 93.375, Minority Biomedical complete applications for a license in
United States of America.
Research Support; 93.821, Cell Biology and
The prospective exclusive license the field of use filed in response to this
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry territory may be worldwide and the notice will be treated as objections to
Research; 93.862, Genetics and field of use may be limited to the use the grant of the contemplated exclusive
Developmental Biology Research; 93.88, of the Licensed Patent Rights to license. Comments and objections
Minority Access to Research Careers; 93.96, develop, make, have made, sell, have submitted to this notice will not be
Special Minority Initiatives, National sold, import and export bi-specific and made available for public inspection
Institutes of Health, HHS) multi-specific fusion proteins that are and, to the extent permitted by law, will
Dated: June 22, 2015. capable of eliciting redirected T-cell not be released under the Freedom of
Melanie J. Gray, cytotoxicity for the treatment of human Information Act, 5 U.S.C. 552.
Program Analyst, Office of Federal Advisory receptor tyrosine kinase-like orphan Dated: June 22, 2015.
Committee Policy. receptor 1 (ROR1) expressing cancers, Richard U. Rodriguez,
[FR Doc. 2015–15659 Filed 6–25–15; 8:45 am]
wherein said fusion proteins comprise
Acting Director, Office of Technology
one or more single-chain variable Transfer, National Institutes of Health.
BILLING CODE 4140–01–P
fragment (scFv) ROR1 binding domains
[FR Doc. 2015–15655 Filed 6–25–15; 8:45 am]
from the anti-ROR1 antibodies
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND designated as R11 or R12, one or more
HUMAN SERVICES of Licensee’s proprietary scFv CD3
binding domains, and optionally a
DEPARTMENT OF HEALTH AND
National Institutes of Health fragment crystallizable (Fc) domain.
HUMAN SERVICES
DATES: Only written comments and/or
Prospective Grant of an Exclusive applications for a license which are National Institutes of Health
License Agreement: Development of received by the NIH Office of
Bispecific and Multi-Specific Fusion Technology Transfer on or before July Prospective Grant of Exclusive
Proteins for the Treatment of ROR1 27, 2015 will be considered. License: The Development of an Anti-
Expressing Human Cancers ADDRESSES: Requests for copies of the CD19 Chimeric Antigen Receptor
AGENCY: National Institutes of Health, patent applications, inquiries, (CAR) for the Treatment of Human
HHS. comments, and other materials relating Cancers
ACTION: Notice. to the contemplated exclusive AGENCY: National Institutes of Health,
evaluation option license should be HHS.
SUMMARY: This is notice, in accordance directed to: Jennifer Wong, M.S., Senior
ACTION: Notice.
with 35 U.S.C. 209 and 37 CFR part 404, Licensing and Patenting Manager, Office
that the National Institutes of Health, of Technology Transfer, National SUMMARY: This is notice, in accordance
Department of Health and Human Institutes of Health, 6011 Executive with 35 U.S.C. 209 and 37 CFR part 404,
Services, is contemplating the grant of Boulevard, Suite 325, Rockville, MD that the National Institutes of Health,
an exclusive license agreement to 20852–3804; Telephone: (301) 435– Department of Health and Human
practice the inventions embodied in US 4633; Facsimile: (301) 402–0220; Email: Services, is contemplating the grant of
Provisional Application No. 61/418,550 wongje@od.nih.gov. an exclusive license to practice the
entitled, ‘‘Chimeric rabbit/human ROR1 SUPPLEMENTARY INFORMATION: Tyrosine inventions embodied in U.S. Provisional
antibodies’’ filed December 1, 2010 kinase-like orphan receptor 1 (ROR1) is Patent Application 62/006,313 entitled
[HHS Ref. E–039–2011/0–US–01]; PCT a signature cell surface antigen for B-cell ‘‘Chimeric Antigen Receptors Targeting
Application No. PCT/US2011/062670 malignancies, most notably, B-cell CD–19’’ [HHS Ref. E–042–2014/0–US–
entitled, ‘‘Chimeric rabbit/human ROR1 chronic lymphocytic leukemia (B–CLL) 01], and all related continuing and
antibodies’’ filed November 30, 2011 and mantle cell lymphoma (MCL) cells, foreign patents/patent applications for
[HHS Ref. E–039–2011/0–PCT–02]; two incurable diseases. The the technology family, to Kite Pharma,
Australian Patent Application No. investigators have developed a portfolio Inc. The patent rights in these
tkelley on DSK3SPTVN1PROD with NOTICES

2011336650 entitled, ‘‘Chimeric rabbit/ of chimeric anti-ROR1 monoclonal inventions have been assigned to and/or
human ROR1 antibodies’’ filed antibodies that selectively target ROR1 exclusively licensed to the Government
November 30, 2011 [HHS Ref. E–039– malignant B-cells but not normal B- of the United States of America.
2011/0–AU–03]; Canadian Patent cells. These antibodies may be linked to The prospective exclusive licensed
Application No. 2818992 entitled, chemical drugs or biological toxins thus territory may be worldwide, and the
‘‘Chimeric rabbit/human ROR1 providing targeted cytotoxic delivery to field of use may be limited to: ‘‘All
antibodies’’ filed November 30, 2011 malignant B-cells while sparing normal prophylactic and therapeutic uses for

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Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices 36829

CD19-associated diseases, states and Complete applications for a license in omb.eop.gov. Comments may also be
conditions in humans.’’ an appropriate field of use that are filed submitted via fax at 202–395–5806.
DATES: Only applications for a license in response to this notice will be treated (This is not a toll free number.) All
which are received by the NIH Office of as objections to the grant of the submissions received must include the
Technology Transfer on or before July contemplated exclusive license. agency name and the OMB Control
27, 2015 will be considered. Comments and objections submitted to Number 1615–0023.
ADDRESSES: Requests for copies of the this notice will not be made available You may wish to consider limiting the
patent application, inquiries, comments, for public inspection and, to the extent amount of personal information that you
and other materials relating to the permitted by law, will not be released provide in any voluntary submission
contemplated exclusive license should under the Freedom of Information Act, you make. For additional information,
be directed to: David A. Lambertson, 5 U.S.C. 552. please read the Privacy Act notice that
Ph.D., Senior Licensing and Patenting Dated: June 22, 2015. is available via the link in the footer of
Manager, Office of Technology Transfer, Richard U. Rodriguez, http://www.regulations.gov.
National Institutes of Health, 6011 Acting Director, Office of Technology
Executive Boulevard, Suite 325, Transfer, National Institutes of Health.
FOR FURTHER INFORMATION CONTACT: If
Rockville, MD 20852–3804; Telephone: you need a copy of the information
[FR Doc. 2015–15657 Filed 6–25–15; 8:45 am]
(301) 435–4632; Facsimile: (301) 402– collection instrument with instructions
BILLING CODE 4140–01–P
0220; Email: lambertsond@mail.nih.gov. or additional information, please
SUPPLEMENTARY INFORMATION: This contact us at: USCIS, Office of Policy
invention concerns an anti-CD19 and Strategy, Regulatory Coordination
DEPARTMENT OF HOMELAND Division, Laura Dawkins, Chief, 20
chimeric antigen receptor (CAR) and SECURITY
methods of using the CAR for the Massachusetts Avenue NW.,
treatment of CD19-expressing cancers, U.S. Citizenship and Immigration Washington, DC 20529–2140,
including B cell malignancies. Services Telephone number 202–272–8377. (This
CD19 is a cell surface antigen that is is not a toll free number.) Please note
[OMB Control Number 1615–0023] contact information provided here is
preferentially expressed on certain types
of cancer cells, particularly cancers of B solely for questions regarding this
Agency Information Collection notice. It is not for individual case
cell origin such as Non-Hodgkin’s Activities: Application To Register
Leukemia (NHL), acute lymphoblastic status inquiries. Applicants seeking
Permanent Residence or Adjust information about the status of their
leukemia (ALL) and chronic Status, Form I–485 Supplement A, and
lymphocytic leukemia (CLL). The anti- individual cases can check Case Status
Instruction Booklet for Filing Form I– Online, available at the USCIS Web site
CD19 CARs of this technology contain 485 and Supplement A, Form I–485;
(1) antigen recognition sequences that at http://www.uscis.gov, or call the
Revision of a Currently Approved USCIS National Customer Service
bind specifically to CD19 and (2) Collection
signaling domains that can activate the Center at 800–375–5283 (TTY 800–767–
cytotoxic functions of a T cell. The anti- AGENCY: U.S. Citizenship and 1833).
CD19 CAR can be transduced into T Immigration Services, Department of SUPPLEMENTARY INFORMATION:
cells that are harvested from a cancer Homeland Security.
patient; from there, T cells expressing ACTION: 30-Day notice. Comments
the anti-CD19 CAR are selected,
expanded and then be reintroduced into SUMMARY: The Department of Homeland Written comments and suggestions
the patient. Once the anti-CD19 CAR- Security (DHS), U.S. Citizenship and from the public and affected agencies
expressing T cells are reintroduced into Immigration Services (USCIS) will be should address one or more of the
the patient, the T cells can selectively submitting the following information following four points:
bind to CD19-expressing cancer cells collection request to the Office of (1) Evaluate whether the proposed
through its antigen recognition Management and Budget (OMB) for collection of information is necessary
sequences, thereby activating the T cell review and clearance in accordance for the proper performance of the
through its signaling domains to with the Paperwork Reduction Act of functions of the agency, including
selectively kill the cancer cells. Through 1995. The information collection notice whether the information will have
this mechanism of action, the selectivity was previously published in the Federal practical utility;
of the a CAR allows the T cells to kill Register on March 10, 2015, at 80 FR
12647, allowing for a 60-day public (2) Evaluate the accuracy of the
cancer cells while leaving healthy, agency’s estimate of the burden of the
essential cells unharmed. This can comment period. USCIS received eight
comments in connection with the 60- proposed collection of information,
result in an effective therapeutic including the validity of the
strategy with fewer side effects due to day notice.
methodology and assumptions used;
less non-specific killing of cells. DATES: The purpose of this notice is to
The prospective exclusive license will allow an additional 30 days for public (3) Enhance the quality, utility, and
be royalty bearing and will comply with comments. Comments are encouraged clarity of the information to be
the terms and conditions of 35 U.S.C. and will be accepted until July 27, 2015. collected; and
209 and 37 CFR part 404. The This process is conducted in accordance (4) Minimize the burden of the
prospective exclusive license may be with 5 CFR 1320.10. collection of information on those who
tkelley on DSK3SPTVN1PROD with NOTICES

granted unless the NIH receives written ADDRESSES: Written comments and/or are to respond, including through the
evidence and argument that establishes suggestions regarding the item(s) use of appropriate automated,
that the grant of the license would not contained in this notice, especially electronic, mechanical, or other
be consistent with the requirements of regarding the estimated public burden technological collection techniques or
35 U.S.C. 209 and 37 CFR part 404 and associated response time, must be other forms of information technology
within thirty (30) days from the date of directed to the OMB USCIS Desk Officer (e.g., permitting electronic submission
this published notice. via email at oira_submission@ of responses).

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Document Created: 2015-12-15 14:15:53
Document Modified: 2015-12-15 14:15:53

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 applications for a license which are received by the NIH Office of Technology Transfer on or before July 27, 2015 will be considered.
FR Citation		80 FR 36828

80 FR 36828 - Prospective Grant of Exclusive License: The Development of an Anti-CD19 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancers

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 123 (June 26, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health