Prospective Grant of Exclusive Option License: The Development of a Single Domain Human Anti-Mesothelin Monoclonal Antibody for the Treatment of Human Cancers, 62168 [2014-24501]

Download as PDF 62168 Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: October 9, 2014. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–24601 Filed 10–15–14; 8:45 am] BILLING CODE 4140–01–P ACTION: Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. asabaliauskas on DSK5VPTVN1PROD with NOTICES Name of Committee: Center for Inherited Disease Research Access Committee. Date: October 29, 2014. Time: 10:00 a.m. to 11:00 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Ken Nakamura, Ph.D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Suite 4076, MSC 9306, Rockville, MD 20852, 301–402–0838. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) Dated: October 10, 2014. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. 17:19 Oct 15, 2014 Jkt 235001 National Institutes of Health, Notice. 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 start-up option license to practice the inventions embodied in U.S. Patent Application 61/706,396 entitled ‘‘Mesothelin Antibodies And Methods For Eliciting Potent Antitumor Activity’’ [HHS Ref. E–236–2012/0–US– 01], PCT Application PCT/US2013/ 059883 entitled ‘‘Mesothelin Antibodies And Methods For Eliciting Potent Antitumor Activity’’ [HHS Ref. E–236– 2012/0–PCT–02], and all related continuing and foreign patents/patent applications for the technology family, to H2Bio, 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 start-up option licensed territory may be worldwide, and the field of use may be limited to: SUMMARY: National Human Genome Research Institute; Notice of Closed Meeting VerDate Sep<11>2014 SUPPLEMENTARY INFORMATION: HHS. National Institutes of Health BILLING CODE 4140–01–P Prospective Grant of Exclusive Option License: The Development of a Single Domain Human Anti-Mesothelin Monoclonal Antibody for the Treatment of Human Cancers AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2014–24605 Filed 10–15–14; 8:45 am] National Institutes of Health 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: lambertsond@mail.nih.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES The use of SD1-serine protease immunoconjugates for the treatment of mesothelioma, pancreatic cancer, ovarian cancer and lung adenocarcinoma, including combination therapies using the SD1-serine protease immunoconjugate, wherein the serine protease is Granzyme B (GrB) or a Derivative thereof. Upon the expiration or termination of the exclusive start-up option license, H2Bio, Inc. will have the exclusive right to execute an exclusive commercialization license which will supersede and replace the exclusive start-up option license with no greater field of use and territory than granted in the exclusive start-up option license. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before October 31, 2014 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 PO 00000 Frm 00077 Fmt 4703 Sfmt 9990 This invention concerns a monoclonal antibody and methods of using the antibody for the treatment of mesothelin-expressing cancers, including mesothelioma, lung cancer, ovarian cancer and pancreatic cancer. The specific antibody covered by this technology is designated SD1, which is a single domain, fully human monoclonal antibody against mesothelin. Mesothelin is a cell surface antigen that is preferentially expressed on certain types of cancer cells. The SD1 antibody can selectively bind to these cancer cells and induce cell death 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 start-up option 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 start-up option 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 fifteen (15) days from the date of this published notice. 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 exclusive start-up 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: October 8, 2014. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2014–24501 Filed 10–15–14; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\16OCN1.SGM 16OCN1

Agencies

[Federal Register Volume 79, Number 200 (Thursday, October 16, 2014)]
[Notices]
[Page 62168]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24501]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Option License: The Development of 
a Single Domain Human Anti-Mesothelin Monoclonal Antibody 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 start-up 
option license to practice the inventions embodied in U.S. Patent 
Application 61/706,396 entitled ``Mesothelin Antibodies And Methods For 
Eliciting Potent Antitumor Activity'' [HHS Ref. E-236-2012/0-US-01], 
PCT Application PCT/US2013/059883 entitled ``Mesothelin Antibodies And 
Methods For Eliciting Potent Antitumor Activity'' [HHS Ref. E-236-2012/
0-PCT-02], and all related continuing and foreign patents/patent 
applications for the technology family, to H2Bio, 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 start-up option licensed territory may be 
worldwide, and the field of use may be limited to:

    The use of SD1-serine protease immunoconjugates for the 
treatment of mesothelioma, pancreatic cancer, ovarian cancer and 
lung adenocarcinoma, including combination therapies using the SD1-
serine protease immunoconjugate, wherein the serine protease is 
Granzyme B (GrB) or a Derivative thereof.

    Upon the expiration or termination of the exclusive start-up option 
license, H2Bio, Inc. will have the exclusive right to execute an 
exclusive commercialization license which will supersede and replace 
the exclusive start-up option license with no greater field of use and 
territory than granted in the exclusive start-up option license.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
October 31, 2014 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: lambertsond@mail.nih.gov.

SUPPLEMENTARY INFORMATION: This invention concerns a monoclonal 
antibody and methods of using the antibody for the treatment of 
mesothelin-expressing cancers, including mesothelioma, lung cancer, 
ovarian cancer and pancreatic cancer. The specific antibody covered by 
this technology is designated SD1, which is a single domain, fully 
human monoclonal antibody against mesothelin.
    Mesothelin is a cell surface antigen that is preferentially 
expressed on certain types of cancer cells. The SD1 antibody can 
selectively bind to these cancer cells and induce cell death 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 start-up option 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 start-up option 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 
fifteen (15) days from the date of this published notice.
    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 exclusive start-up 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: October 8, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-24501 Filed 10-15-14; 8:45 am]
BILLING CODE 4140-01-P
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