81 FR 19211 - Prospective Grant of Exclusive License: Development of 5T4 Antibodies in Human Cancer Therapeutics and Diagnostics

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 64 (April 4, 2016)

Page Range		19211-19211
FR Document		2016-07556

This 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 practice the inventions embodied in the following U.S. Patents and Patent Applications to Ovensa, Inc. (``Ovensa'') located in Ontario, Canada.

Federal Register, Volume 81 Issue 64 (Monday, April 4, 2016)

[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Notices]
[Page 19211]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-07556]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of 5T4 
Antibodies in Human Cancer Therapeutics and Diagnostics

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: This 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 practice the inventions embodied in the 
following U.S. Patents and Patent Applications to Ovensa, Inc. 
(``Ovensa'') located in Ontario, Canada.

Intellectual Property

    U.S. Provisional Patent Application No. 62/034,995 filed August 8, 
2014 entitled ``Human Monoclonal Antibodies Specific for 5T4 and 
Methods of Their Use'' [HHS Ref. No. E-158-2014/0-US-01];
    PCT Application No. PCT/US2015/044253 filed August 8, 2015 entitled 
``Human Monoclonal Antibodies Specific for 5T4 and Methods of Their 
Use'' [HHS Ref. No. E-158-2014/0-PCT-02].
    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 use of the Licensed Patent 
Rights in combination with the Licensee's proprietary or exclusively 
in-licensed platforms and technologies for the treatment, prevention or 
diagnosis of cancer.''

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 April 19, 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: Rose Freel, Ph.D., Licensing and Patenting Manager, 
Technology Transfer Center, National Cancer Institute, 8490 Progress 
Drive, Riverside 5, Suite 400, Frederick, MD 21702; Telephone: (301) 
624-1257; Email: [email protected].

SUPPLEMENTARY INFORMATION: 5T4 is an antigen expressed on many 
different types of cancers, especially solid tumors. Its expression is 
limited in normal tissue, but is prevalent in malignant tumors 
throughout their development making it an attractive target for cancer 
immunotherapy. 5T4 is often found in colorectal, ovarian, and gastric 
tumors and as a result, has been used as a prognostic aid for these 
cancers. The role of 5T4 in antibody-directed immunotherapy has been 
studied using murine monoclonal antibodies (mAbs). In addition, the 
cancer vaccine TroVax (currently in clinical trials for multiple solid 
tumors) targets 5T4. The present invention describes the identification 
and characterization of two fully human mAbs (m1001 and m1002) that 
bind to 5T4. Since the mAbs are fully human, they could have less 
immunogenicity and better safety profiles than the existing mouse and 
humanized antibodies. These mAbs have the potential to be cancer 
therapeutics as naked mAbs, chimeric antigen receptors (CARs) or 
antibody-drug conjugates (ADCs).
    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 
404.7. The prospective exclusive license 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 404.7.
    Applications for a license in the field of use 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: March 29, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-07556 Filed 4-1-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices 19211

Dated: March 29, 2016. Rose Freel, Ph.D., Licensing and DEPARTMENT OF HEALTH AND
Melanie J. Gray, Patenting Manager, Technology Transfer HUMAN SERVICES
Program Analyst, Office of Federal Advisory Center, National Cancer Institute, 8490
Committee Policy. Progress Drive, Riverside 5, Suite 400, National Institutes of Health
[FR Doc. 2016–07484 Filed 4–1–16; 8:45 am] Frederick, MD 21702; Telephone: (301)
624–1257; Email: rose.freel@nih.gov. Center for Scientific Review; Notice of
BILLING CODE 4140–01–P
Closed Meetings
SUPPLEMENTARY INFORMATION: 5T4 is an
antigen expressed on many different Pursuant to section 10(d) of the
DEPARTMENT OF HEALTH AND
types of cancers, especially solid Federal Advisory Committee Act, as
HUMAN SERVICES
tumors. Its expression is limited in amended (5 U.S.C. App.), notice is
National Institutes of Health normal tissue, but is prevalent in hereby given of the following meetings.
malignant tumors throughout their The meetings will be closed to the
Prospective Grant of Exclusive development making it an attractive public in accordance with the
License: Development of 5T4 target for cancer immunotherapy. 5T4 is provisions set forth in sections
Antibodies in Human Cancer often found in colorectal, ovarian, and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Therapeutics and Diagnostics gastric tumors and as a result, has been as amended. The grant applications and
used as a prognostic aid for these the discussions could disclose
AGENCY: National Institutes of Health,
cancers. The role of 5T4 in antibody- confidential trade secrets or commercial
HHS.
directed immunotherapy has been property such as patentable material,
ACTION: Notice. and personal information concerning
studied using murine monoclonal
SUMMARY: This notice, in accordance antibodies (mAbs). In addition, the individuals associated with the grant
with 35 U.S.C. 209 and 37 CFR part 404, cancer vaccine TroVax (currently in applications, the disclosure of which
that the National Cancer Institute, clinical trials for multiple solid tumors) would constitute a clearly unwarranted
National Institutes of Health, targets 5T4. The present invention invasion of personal privacy.
Department of Health and Human describes the identification and Name of Committee: Center for Scientific
Services, is contemplating the grant of characterization of two fully human Review Special Emphasis Panel; AIDS and
an exclusive patent license to practice mAbs (m1001 and m1002) that bind to Related Research NAED Conflicts.
the inventions embodied in the 5T4. Since the mAbs are fully human, Date: April 5, 2016.
following U.S. Patents and Patent Time: 10:00 a.m. to 6:00 p.m.
they could have less immunogenicity Agenda: To review and evaluate grant
Applications to Ovensa, Inc. (‘‘Ovensa’’) and better safety profiles than the applications.
located in Ontario, Canada. existing mouse and humanized Place: National Institutes of Health, 6701
Intellectual Property antibodies. These mAbs have the Rockledge Drive, Bethesda, MD 20892
potential to be cancer therapeutics as (Virtual Meeting).
U.S. Provisional Patent Application naked mAbs, chimeric antigen receptors Contact Person: Robert Freund, Ph.D.,
No. 62/034,995 filed August 8, 2014 (CARs) or antibody-drug conjugates Scientific Review Officer, Center for
entitled ‘‘Human Monoclonal (ADCs). Scientific Review, National Institutes of
Antibodies Specific for 5T4 and Health, 6701 Rockledge Drive, Room 5216,
Methods of Their Use’’ [HHS Ref. No. E– The prospective exclusive license will MSC 7852, Bethesda, MD 20892, 301–435–
158–2014/0–US–01]; be royalty bearing and will comply with 1050, freundr@csr.nih.gov.
PCT Application No. PCT/US2015/ the terms and conditions of 35 U.S.C. This notice is being published less than 15
044253 filed August 8, 2015 entitled 209 and 37 CFR part 404.7. The days prior to the meeting due to the timing
‘‘Human Monoclonal Antibodies prospective exclusive license may be limitations imposed by the review and
Specific for 5T4 and Methods of Their granted unless within fifteen (15) days funding cycle.
Use’’ [HHS Ref. No. E–158–2014/0– from the date of this published notice, Name of Committee: Center for Scientific
PCT–02]. the National Cancer Institute receives Review Special Emphasis Panel; PAR16–028:
HIV/AIDS Vaccine Scholars Program.
The patent rights in these inventions written evidence and argument that Date: April 7, 2016.
have been assigned to the government of establishes that the grant of the license Time: 1:00 p.m. to 4:00 p.m.
the United States of America. would not be consistent with the Agenda: To review and evaluate grant
The prospective exclusive license requirements of 35 U.S.C. 209 and 37 applications.
territory may be worldwide and the CFR part 404.7. Place: National Institutes of Health, 6701
field of use may be limited to ‘‘the use Rockledge Drive, Bethesda, MD 20892
Applications for a license in the field
of the Licensed Patent Rights in (Telephone Conference Call).
combination with the Licensee’s of use filed in response to this notice Contact Person: Barna Dey, Ph.D.,
proprietary or exclusively in-licensed will be treated as objections to the grant Scientific Review Officer, Center for
platforms and technologies for the of the contemplated exclusive license. Scientific Review, National Institutes of
treatment, prevention or diagnosis of Comments and objections submitted to Health, 6701 Rockledge Drive, Room 3184,
this notice will not be made available Bethesda, MD 20892, 301–451–2796, bdey@
cancer.’’ mail.nih.gov.
for public inspection and, to the extent
DATES: Only written comments and/or permitted by law, will not be released This notice is being published less than 15
applications for a license which are under the Freedom of Information Act, days prior to the meeting due to the timing
received by the Technology Transfer limitations imposed by the review and
mstockstill on DSK4VPTVN1PROD with NOTICES

5 U.S.C. 552.
Center at the National Cancer Institute funding cycle.
on or before April 19, 2016 will be Dated: March 29, 2016. Name of Committee: Center for Scientific
considered. Richard U. Rodriguez, Review Special Emphasis Panel; PAR Panel:
Multidisciplinary Studies on HIV and Aging.
ADDRESSES: Requests for copies of the Associate Director, Technology Transfer
Date: April 8, 2016.
patent application, inquiries, and Center, National Cancer Institute.
Time: 8:00 a.m. to 5:00 p.m.
comments relating to the contemplated [FR Doc. 2016–07556 Filed 4–1–16; 8:45 am] Agenda: To review and evaluate grant
exclusive license should be directed to: BILLING CODE 4140–01–P applications.

VerDate Sep<11>2014 19:03 Apr 01, 2016 Jkt 238001 PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 E:\FR\FM\04APN1.SGM 04APN1

Document Created: 2016-04-02 03:53:45
Document Modified: 2016-04-02 03:53:45

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 Technology Transfer Center at the National Cancer Institute on or before April 19, 2016 will be considered.
FR Citation		81 FR 19211

81 FR 19211 - Prospective Grant of Exclusive License: Development of 5T4 Antibodies in Human Cancer Therapeutics and Diagnostics

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 64 (April 4, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health