80 FR 15226 - Prospective Grant of Start-up Exclusive Evaluation Option License Agreement: Pre-Clinical Evaluation and Commercial Development of Anti-Tyrosine Kinase-Like Orphan Receptor 1 Antibody-Drug Conjugates for the Treatment of Human Cancers
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 55 (March 23, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 55 (March 23, 2015)
| Page Range | 15226-15227 | |
| FR Document | 2015-06486 |
[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)] [Notices] [Pages 15226-15227] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06486] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-up Exclusive Evaluation Option License Agreement: Pre-Clinical Evaluation and Commercial Development of Anti- Tyrosine Kinase-Like Orphan Receptor 1 Antibody-Drug Conjugates 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 a start-up exclusive evaluation option license agreement to practice the inventions embodied in U.S. Patent Application No. 61/172,099 entitled ``Anti-human ROR1 Antibodies'' filed April 23, 2009 [HHS Ref. E-097-2009/0-US-01], PCT Application No. PCT/US2010/032208 entitled ``Anti-human ROR1 Antibodies'' filed April 23, 2010 [HHS Ref. E-097-2009/0-PCT-02], European Patent Application No. 10715077.3 entitled, ``Anti-human ROR1 Antibodies'' filed October 24, 2011 [HHS Ref. No. E-097-2009/0-EP-03], U.S. Patent Application No. 13/265,582 entitled, ``Anti-human ROR1 Antibodies'' filed October 21, 2011 [HHS Ref. No. E-097-2009/0-US-04], Australian Patent Application No. 2010238723 entitled, ``Anti-human ROR1 Antibodies'' filed October 21, 2011 [HHS Ref. No. E-097-2009/0-AU- 04], Canadian Patent Application No. 2,759,733 entitled, ``Anti-human ROR1 Antibodies'' filed October 21, 2011 [HHS Ref. No. E-097-2009/0-CA- 05], US Provisional Application No. 61/418,550 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed December 1, 2010 [HHS Ref. E-039- 2011/0-US-01], PCT Application No. PCT/US2011/062670 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-PCT-02]; Australian Patent Application No. 2011336650 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-AU-03], Canadian Patent Application No. 2818992 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-CA-04], European Patent Application No. 11791733.6 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-EP-05] and U.S. Patent Application No. 13/990,977 entitled, ``Chimeric rabbit/ human ROR1 antibodies'' filed May 31, 2013 [HHS Ref. E-039-2011/0-US- 06] and all related continuing and foreign patents/patent applications for the technology family to NBE Therapeutics, Ltd. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective start-up exclusive evaluation option license territory may be worldwide and the field of use may be limited to pre- clinical evaluation and commercial development of an antibody-drug conjugate comprising an anti-tyrosine protein kinase transmembrane receptor (ROR1) antibody for the treatment of human ROR1 expressing cancers utilizing enzymatic conjugation methods linking a small molecule to a full-length antibody, wherein the full-length antibody moiety comprises the anti-ROR1 antibodies or CDR3s within the scope of the Licensed Patent Rights. For avoidance of doubt, this Agreement explicitly excludes the following: (a) Antibody-drug conjugates utilizing non-enzymatic conjugation linking small molecules to said antibodies, (b) immunotoxins comprising anti-ROR1 antibodies and Pseudomonas exotoxins, and (c) non-full-length bispecific antibodies. Upon expiration or termination of the start-up exclusive evaluation option license, NBE Therapeutics, Ltd. will have the right to execute a start-up exclusive patent commercialization license which will supersede and replace the start-up exclusive evaluation option license with no broader territory than granted in the start-up exclusive evaluation option license and the field of use will be commensurate with the commercial development plan at the time of conversion. DATED: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before April 6, 2015 will be considered. [[Page 15227]] ADDRESSES: Requests for copies of the patent applications, inquiries, comments, and other materials relating to the contemplated exclusive evaluation option license should be directed to: Jennifer Wong, M.S., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-4633; Facsimile: (301) 402-0220; Email: [email protected]. SUPPLEMENTARY INFORMATION: Tyrosine kinase-like orphan receptor 1 (ROR1) is a signature cell surface antigen for B-cell malignancies, most notably, B-cell chronic lymphocytic leukemia (B-CLL) and mantle cell lymphoma (MCL) cells, two incurable diseases. The investigators have developed a portfolio of chimeric anti-ROR1 monoclonal antibodies that selectively target ROR1 malignant B-cells but not normal B-cells. These antibodies may be linked to chemical drugs or biological toxins thus providing targeted cytotoxic delivery to malignant B-cells while sparing normal cells. Moreover, as these antibodies selectively target ROR1, they can also be used to diagnose B-cell malignancies. The prospective start-up exclusive evaluation option license is being considered under the small business initiative launched on October 1, 2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective start-up exclusive evaluation option license, and a subsequent start-up exclusive patent commercialization license, may be granted unless within fifteen (15) days from the date of this published notice, 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. Any additional, properly filed, and complete 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 start-up exclusive evaluation option 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 16, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015-06486 Filed 3-20-15; 8:45 am] BILLING CODE 4140-01-P
![15226 Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
DEPARTMENT OF HEALTH AND Research; 93.397, Cancer Centers Support; Australian Patent Application No.
HUMAN SERVICES 93.398, Cancer Research Manpower; 93.399, 2011336650 entitled, ‘‘Chimeric rabbit/
Cancer Control, National Institutes of Health, human ROR1 antibodies’’ filed
National Institutes of Health HHS)
November 30, 2011 [HHS Ref. E–039–
Dated: March 17, 2015. 2011/0–AU–03], Canadian Patent
National Cancer Institute; Notice of Melanie J. Gray, Application No. 2818992 entitled,
Closed Meetings Program Analyst, Office of Federal Advisory ‘‘Chimeric rabbit/human ROR1
Pursuant to section 10(d) of the Committee Policy. antibodies’’ filed November 30, 2011
Federal Advisory Committee Act, as [FR Doc. 2015–06477 Filed 3–20–15; 8:45 am] [HHS Ref. E–039–2011/0–CA–04],
amended (5 U.S.C. App.), notice is BILLING CODE 4140–01–P European Patent Application No.
hereby given of the following meetings. 11791733.6 entitled, ‘‘Chimeric rabbit/
The meetings will be closed to the human ROR1 antibodies’’ filed
public in accordance with the DEPARTMENT OF HEALTH AND November 30, 2011 [HHS Ref. E–039–
provisions set forth in sections HUMAN SERVICES 2011/0–EP–05] and U.S. Patent
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Application No. 13/990,977 entitled,
as amended. The grant applications and National Institutes of Health ‘‘Chimeric rabbit/human ROR1
the discussions could disclose antibodies’’ filed May 31, 2013 [HHS
Prospective Grant of Start-up
confidential trade secrets or commercial Ref. E–039–2011/0–US–06] and all
Exclusive Evaluation Option License
property such as patentable material, related continuing and foreign patents/
Agreement: Pre-Clinical Evaluation
and personal information concerning patent applications for the technology
and Commercial Development of Anti-
individuals associated with the grant family to NBE Therapeutics, Ltd. The
Tyrosine Kinase-Like Orphan Receptor
applications, the disclosure of which patent rights in these inventions have
1 Antibody-Drug Conjugates for the
would constitute a clearly unwarranted been assigned to the Government of the
Treatment of Human Cancers
invasion of personal privacy. United States of America.
Name of Committee: National Cancer AGENCY: National Institutes of Health, The prospective start-up exclusive
Institute Special Emphasis Panel; New HHS. evaluation option license territory may
Approaches to Synthetic Lethality for Mutant ACTION: Notice. be worldwide and the field of use may
KRas-Dependent Cancers (U01). be limited to pre-clinical evaluation and
Date: April 13, 2015. SUMMARY: This is notice, in accordance
Time: 11:00 a.m. to 5:00 p.m. commercial development of an
with 35 U.S.C. 209 and 37 CFR part 404, antibody-drug conjugate comprising an
Agenda: To review and evaluate grant
applications.
that the National Institutes of Health, anti-tyrosine protein kinase
Place: National Cancer Institute Shady Department of Health and Human transmembrane receptor (ROR1)
Grove; 9609 Medical Center Drive; Room Services, is contemplating the grant of a antibody for the treatment of human
7W032; Rockville, MD 20850; (Telephone start-up exclusive evaluation option ROR1 expressing cancers utilizing
Conference Call). license agreement to practice the enzymatic conjugation methods linking
Contact Person: Clifford W. Schweinfest, inventions embodied in U.S. Patent a small molecule to a full-length
Ph.D.; Scientific Review Officer; Special Application No. 61/172,099 entitled
Review Branch; Division of Extramural
antibody, wherein the full-length
‘‘Anti-human ROR1 Antibodies’’ filed antibody moiety comprises the anti-
Activities; National Cancer Institute, NIH;
April 23, 2009 [HHS Ref. E–097–2009/ ROR1 antibodies or CDR3s within the
9609 Medical Center Drive, Room 7W108;
Bethesda, MD 20892–9750; 240–276–6343; 0–US–01], PCT Application No. PCT/ scope of the Licensed Patent Rights. For
schweinfestcw@mail.nih.gov. US2010/032208 entitled ‘‘Anti-human avoidance of doubt, this Agreement
Name of Committee: National Cancer ROR1 Antibodies’’ filed April 23, 2010 explicitly excludes the following: (a)
Institute Initial Review Group; Subcommittee [HHS Ref. E–097–2009/0–PCT–02], Antibody-drug conjugates utilizing non-
A—Cancer Centers. European Patent Application No. enzymatic conjugation linking small
Date: May 7, 2015. 10715077.3 entitled, ‘‘Anti-human molecules to said antibodies, (b)
Time: 8:00 a.m. to 4:45 p.m. ROR1 Antibodies’’ filed October 24, immunotoxins comprising anti-ROR1
Agenda: To review and evaluate grant 2011 [HHS Ref. No. E–097–2009/0–EP– antibodies and Pseudomonas exotoxins,
applications. 03], U.S. Patent Application No. 13/
Place: Doubletree Hotel Bethesda;
and (c) non-full-length bispecific
265,582 entitled, ‘‘Anti-human ROR1 antibodies. Upon expiration or
(Formerly Holiday Inn Select); 8120
Antibodies’’ filed October 21, 2011 termination of the start-up exclusive
Wisconsin Avenue; Bethesda, MD 20814.
Contact Person: Shamala K. Srinivas, [HHS Ref. No. E–097–2009/0–US–04], evaluation option license, NBE
Ph.D.; Associate Director; Office of Referral, Australian Patent Application No. Therapeutics, Ltd. will have the right to
Review, and Program Coordination; Division 2010238723 entitled, ‘‘Anti-human execute a start-up exclusive patent
of Extramural Activities; National Cancer ROR1 Antibodies’’ filed October 21, commercialization license which will
Institute, NIH; 9609 Medical Center Drive, 2011 [HHS Ref. No. E–097–2009/0–AU– supersede and replace the start-up
7W530; Bethesda, MD 20892–9750; 240–276– 04], Canadian Patent Application No. exclusive evaluation option license with
6442; ss537t@nih.gov. 2,759,733 entitled, ‘‘Anti-human ROR1 no broader territory than granted in the
Information is also available on the Antibodies’’ filed October 21, 2011 start-up exclusive evaluation option
Institute’s/Center’s home page: http:// [HHS Ref. No. E–097–2009/0–CA–05],
deainfo.nci.nih.gov/advisory/sep/sep.htm,
license and the field of use will be
US Provisional Application No. 61/ commensurate with the commercial
where an agenda and any additional
mstockstill on DSK4VPTVN1PROD with NOTICES
418,550 entitled, ‘‘Chimeric rabbit/ development plan at the time of
information for the meeting will be posted
when available. human ROR1 antibodies’’ filed conversion.
December 1, 2010 [HHS Ref. E–039–
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction; 2011/0–US–01], PCT Application No. DATED: Only written comments and/or
93.393, Cancer Cause and Prevention PCT/US2011/062670 entitled, applications for a license which are
Research; 93.394, Cancer Detection and ‘‘Chimeric rabbit/human ROR1 received by the NIH Office of
Diagnosis Research; 93.395, Cancer antibodies’’ filed November 30, 2011 Technology Transfer on or before April
Treatment Research; 93.396, Cancer Biology [HHS Ref. E–039–2011/0–PCT–02]; 6, 2015 will be considered.
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![Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices 15227
ADDRESSES: Requests for copies of the DEPARTMENT OF HEALTH AND Dated: March 17, 2015.
patent applications, inquiries, HUMAN SERVICES Melanie J. Gray,
comments, and other materials relating Program Analyst, Office of Federal Advisory
to the contemplated exclusive National Institutes of Health Committee Policy.
evaluation option license should be [FR Doc. 2015–06476 Filed 3–20–15; 8:45 am]
directed to: Jennifer Wong, M.S., Senior National Cancer Institute; Notice of BILLING CODE 4140–01–P
Licensing and Patenting Manager, Office Closed Meeting
of Technology Transfer, National
Pursuant to section 10(d) of the DEPARTMENT OF HEALTH AND
Institutes of Health, 6011 Executive
Federal Advisory Committee Act, as HUMAN SERVICES
Boulevard, Suite 325, Rockville, MD
amended (5 U.S.C. Appendix 2); notice
20852–3804; Telephone: (301) 435–
is hereby given of the following National Institutes of Health
4633; Facsimile: (301) 402–0220; Email: meeting.
wongje@od.nih.gov. Center for Scientific Review; Notice of
The meeting will be closed to the
SUPPLEMENTARY INFORMATION: Tyrosine public in accordance with the Closed Meetings
kinase-like orphan receptor 1 (ROR1) is provisions set forth in sections Pursuant to section 10(d) of the
a signature cell surface antigen for B-cell 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Federal Advisory Committee Act, as
malignancies, most notably, B-cell as amended. The purpose of this amended (5 U.S.C. App.), notice is
chronic lymphocytic leukemia (B–CLL) meeting is to evaluate requests for hereby given of the following meetings.
and mantle cell lymphoma (MCL) cells, preclinical development resources for The meetings will be closed to the
two incurable diseases. The potential new therapeutics for the public in accordance with the
investigators have developed a portfolio treatment of cancer. The outcome of the provisions set forth in sections
of chimeric anti-ROR1 monoclonal evaluation will provide information to 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
antibodies that selectively target ROR1 internal NCI committees that will as amended. The grant applications and
malignant B-cells but not normal B- decide whether NCI should support the discussions could disclose
cells. These antibodies may be linked to requests and make available contract confidential trade secrets or commercial
chemical drugs or biological toxins thus resources for development of the property such as patentable material,
providing targeted cytotoxic delivery to potential therapeutic to improve the and personal information concerning
malignant B-cells while sparing normal treatment of various forms of cancer. individuals associated with the grant
cells. Moreover, as these antibodies The research proposals and the applications, the disclosure of which
selectively target ROR1, they can also be discussions could disclose confidential would constitute a clearly unwarranted
used to diagnose B-cell malignancies. trade secrets or commercial property invasion of personal privacy.
The prospective start-up exclusive such as patentable material, and Name of Committee: Center for Scientific
evaluation option license is being personal information concerning Review Special Emphasis Panel; Drug
considered under the small business individuals associated with the Discovery.
initiative launched on October 1, 2011 proposed research projects, the Date: April 2, 2015.
and will comply with the terms and disclosure of which would constitute a Time: 1:00 p.m. to 3:00 p.m.
conditions of 35 U.S.C. 209 and 37 CFR clearly unwarranted invasion of Agenda: To review and evaluate grant
personal privacy. applications.
part 404. The prospective start-up Place: National Institutes of Health, 6701
exclusive evaluation option license, and Name of Committee: National Cancer Rockledge Drive, Bethesda, MD 20892,
a subsequent start-up exclusive patent Institute Special Emphasis Panel; Feb2015 (Telephone Conference Call).
commercialization license, may be Cycle 19 NExT SEP Committee Meeting. Contact Person: Peter B. Guthrie, Ph.D.,
granted unless within fifteen (15) days Date: April 29, 2015. Scientific Review Officer, Center for
from the date of this published notice, Time: 8:30 a.m. to 4:30 p.m. Scientific Review, National Institutes of
the NIH receives written evidence and Agenda: To evaluate the NCI Experimental Health, 6701 Rockledge Drive, Room 4142,
Therapeutics Program Portfolio. MSC 7850, Bethesda, MD 20892, (301) 435–
argument that establishes that the grant Place: National Institutes of Health, 9000 1239, guthriep@csr.nih.gov.
of the license would not be consistent Rockville Pike, Campus Building 31, This notice is being published less than 15
with the requirements of 35 U.S.C. 209 Conference Room 6C10, Bethesda, MD 20892. days prior to the meeting due to the timing
and 37 CFR part 404. Contact Persons: Barbara Mroczkowski, limitations imposed by the review and
Any additional, properly filed, and Ph.D., Executive Secretary, Discovery funding cycle.
complete applications for a license in Experimental Therapeutics Program, Name of Committee: Center for Scientific
National Cancer Institute, NIH, 31 Center Review Special Emphasis Panel; Member
the field of use filed in response to this Drive, Room 3A44, Bethesda, MD 20817,
notice will be treated as objections to Conflict: Exercise in aging, ischemia imaging.
(301) 496–4291, mroczkoskib@mail.nih.gov; Date: April 2, 2015.
the grant of the contemplated start-up Joseph Tomaszewski, Ph.D., Executive Time: 12:01 p.m. to 1:30 p.m.
exclusive evaluation option license. Secretary, Development Experimental Agenda: To review and evaluate grant
Comments and objections submitted to Therapeutics Program, National Cancer applications.
this notice will not be made available Institute, NIH, 31 Center Drive, Room 3A44, Place: National Institutes of Health, 6701
for public inspection and, to the extent Bethesda, MD 20817, (301) 496–6711, Rockledge Drive, Bethesda, MD 20892,
permitted by law, will not be released tomaszej@mail.nih.gov. (Telephone Conference Call).
under the Freedom of Information Act, (Catalogue of Federal Domestic Assistance Contact Person: Samuel C. Edwards, Ph.D.,
Program Nos. 93.392, Cancer Construction; IRG CHIEF, Center for Scientific Review,
mstockstill on DSK4VPTVN1PROD with NOTICES
5 U.S.C. 552.
93.393, Cancer Cause and Prevention National Institutes of Health, 6701 Rockledge
Dated: March 16, 2015. Research; 93.394, Cancer Detection and Drive, Room 5210, MSC 7846, Bethesda, MD
Richard U. Rodriguez, Diagnosis Research; 93.395, Cancer 20892, (301) 435–1246,
Treatment Research; 93.396, Cancer Biology edwardss@csr.nih.gov.
Acting Director, Office of Technology
Research; 93.397, Cancer Centers Support; This notice is being published less than 15
Transfer, National Institutes of Health.
93.398, Cancer Research Manpower; 93.399, days prior to the meeting due to the timing
[FR Doc. 2015–06486 Filed 3–20–15; 8:45 am] Cancer Control, National Institutes of Health, limitations imposed by the review and
BILLING CODE 4140–01–P HHS) funding cycle.
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Document Created: 2018-02-21 09:47:31
Document Modified: 2018-02-21 09:47:31
| 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. | |
| FR Citation | 80 FR 15226 |
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