Prospective Grant of Exclusive Option License: The Development of a Single Domain Human Anti-Mesothelin Monoclonal Antibody as a Bispecific Antibody for the Treatment of Human Cancers., 25309-25310 [2015-10276]
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Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review Notice of
Closed Meetings
mstockstill on DSK4VPTVN1PROD with NOTICES
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 meetings.
The meetings 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.
Name of Committee: Cell Biology
Integrated Review Group; Molecular and
Integrative Signal Transduction Study
Section.
Date: June 1–2, 2015.
Time: 8:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Raya Mandler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5134,
MSC 7840, Bethesda, MD 20892, (301) 402–
8228, rayam@csr.nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Lung Cellular, Molecular, and
Immunobiology Study Section
Date: June 2–3, 2015.
Time: 7:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Pier 5 Hotel, 711 Eastern Avenue,
Baltimore, MD 21202.
Contact Person: George M Barnas, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2180,
MSC 7818, Bethesda, MD 20892, 301–435–
0696, barnasg@csr.nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Sensorimotor
Integration Study Section.
Date: June 2, 2015.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites DC Convention
Center, 900 10th Street, Washington, DC
20001.
Contact Person: John Bishop, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5182,
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19:40 May 01, 2015
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MSC 7844, Bethesda, MD 20892, (301) 408–
9664, bishopj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Pilot Clinical Studies in Nephrology and
Urology.
Date: June 2–3, 2015.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Atul Sahai, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2188,
MSC 7818, Bethesda, MD 20892, 301–435–
1198, sahaia@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Temporal
dynamics of Neurophysiological Patterns as
Potential Targets for Treating Cognitive
Deficits in Brain Disorders.
Date: June 2, 2015
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Wei-Qin Zhao, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5181
MSC 7846, Bethesda, MD 20892–7846, 301–
435–1236, zhaow@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: April 28, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–10273 Filed 5–1–15; 8:45 am]
BILLING CODE 4140–01–P
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 as a Bispecific
Antibody for the Treatment of Human
Cancers.
AGENCY:
National Institutes of Health,
HHS.
ACTION:
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
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
25309
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 Oncolinx Pharmaceuticals, LLC. 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 bispecific antibodies
having:
(a) The complementary determining
regions (CDRs) of the monoclonal
antibody SD1; and
(b) the CDRs of an anti-CD3 antibody,
for the treatment of mesothelinexpressing cancers. The Licensed Field
of Use explicitly excludes the use of the
CDR sequences of SD1 in a
monospecific antibody, or in the form of
an immunotoxin, antibody-drug
conjugate, or chimeric antigen receptor.
Upon the expiration or termination of
the exclusive start-up option license,
Oncolinx Pharmaceuticals, LLC 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 May
19, 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: 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.
E:\FR\FM\04MYN1.SGM
04MYN1
25310
Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices
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.
[FR Doc. 2015–10276 Filed 5–1–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2015–0042]
Navigation Safety Advisory Council;
Vacancies
Coast Guard, DHS.
Request for applications.
AGENCY:
The Coast Guard seeks
applications for membership on the
Navigation Safety Advisory Council.
The Navigation Safety Advisory Council
provides advice and recommendations
to the Secretary of Homeland Security,
through the Commandant of the U.S.
Coast Guard, on matters relating to
maritime collisions, rammings, and
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SUMMARY:
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19:40 May 01, 2015
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Completed applications should
reach the Coast Guard on or before June
30, 2015.
ADDRESSES: Applicants should send a
cover letter expressing interest in an
appointment to the Navigation Safety
Advisory Council that also indentifies
which membership category the
applicant is applying under, along with
the resume detailing the applicant’s
experience via one of the following
methods:
• By mail: Commandant (CG–NAV)/
NAVSAC Attn: Mr. George Detweiler,
Alternate Designated Federal Officer,
Commandant (CG–NAV), U.S. Coast
Guard 2703 Martin Luther King Avenue
SE., STOP 7418, Washington, DC
20593–7418;
• By fax to 202–372–1991; or
• By email to George.H.Detweiler@
uscg.mil.
DATES:
Mr.
George Detweiler, the Navigation Safety
Advisory Council Alternate Designated
Federal Officer, telephone 202–372–
1566, fax 202–372–1991, or email
George.H.Detweiler@uscg.mil; or Mr.
Burt Lahn, Navigation Safety Advisory
Council coordinator, telephone 202–
372–1526, or email Burt.A.Lahn@
uscg.mil.
FOR FURTHER INFORMATION CONTACT:
The
Navigation Safety Advisory Council is a
federal advisory committee authorized
by 33 U.S.C. 2073 and chartered under
the Federal Advisory Committee Act, (5
U.S.C. Appendix). The Navigation
Safety Advisory Council provides
advice and recommendations to the
Secretary, through the Commandant of
the U.S. Coast Guard, on matters
relating to maritime collisions,
rammings, and groundings; Inland Rules
of the Road; International Rules of the
Road; navigation regulations and
equipment; routing measures; marine
information; diving safety; and aids to
navigation systems.
The Navigation Safety Advisory
Council is expected to meet at least
twice each year, or more often with the
approval of the Designated Federal
Officer. All members serve at their own
expense and receive no salary from the
Federal Government, although travel
reimbursement and per diem may be
provided for called meetings. The
Navigation Safety Advisory Council is
composed of not more than 21 members
who all will have expertise in Inland
SUPPLEMENTARY INFORMATION:
Dated: April 27, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
ACTION:
groundings; Inland Rules of the Road;
International Rules of the Road;
navigation regulations and equipment;
routing measures; marine information;
diving safety; and aids to navigation
systems.
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Fmt 4703
Sfmt 4703
and International vessel navigation
Rules of the Road, aids to maritime
navigation, maritime law, vessel safety,
port safety, or commercial diving safety.
Each member will be appointed to
represent the viewpoints and interests
of one of the following groups or
organizations, and at least one member
will be appointed to represent each
membership category:
a. Commercial vessel owners or
operators;
b. Professional mariners;
c. Recreational boaters;
d. The recreational boating industry;
e. State agencies responsible for vessel
or port safety; and
f. The Maritime Law Association.
Members serve as representatives and
are not Special Government Employees
as defined in section 202(a) of Title 18,
U.S.C.
The Coast Guard will consider
applications for seven positions that
expire or become vacant on November
4, 2015, in the following categories:
a. Professional mariners;
b. Recreational boaters;
c. Recreational Boating Industry; and
d. State agencies responsible for
vessel or port safety;
To be eligible, you should have
experience in one of the categories
listed above. Members serve terms of
office of up to three (3) years. Members
may be reappointed to an additional
term, serving not more than six
consecutive years. In the event the
Navigation Safety Advisory Council
terminates, all appointments to the
Council terminate.
The Department of Homeland
Security does not discriminate in
selection of Council members on the
basis of race, color, religion, sex,
national origin, political affiliation,
sexual orientation, gender identity,
marital status, disabilities and genetic
information, age, membership in an
employee organization, or any other
non-merit factor. The Department of
Homeland Security strives to achieve a
widely diverse candidate pool for all of
its recruitment actions.
If you are interested in applying to
become a member of the Council,
submit your cover letter and resume to
Mr. George Detweiler, the Navigation
Safety Advisory Council Alternate
Designated Federal Officer by email or
mail according to instructions in the
ADDRESSES section by the deadline in
the DATES section of this notice.
All email submittals will receive
email receipt confirmation.
To visit our online docket, go to
https://www.regulations.gov. Enter the
docket number for this notice (USCG–
2015–0042) in the Search box, and click
E:\FR\FM\04MYN1.SGM
04MYN1
]]>Agencies
[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Notices]
[Pages 25309-25310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10276]
-----------------------------------------------------------------------
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 as a
Bispecific 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 Oncolinx Pharmaceuticals,
LLC. 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 bispecific antibodies having:
(a) The complementary determining regions (CDRs) of the monoclonal
antibody SD1; and
(b) the CDRs of an anti-CD3 antibody,
for the treatment of mesothelin-expressing cancers. The Licensed Field
of Use explicitly excludes the use of the CDR sequences of SD1 in a
monospecific antibody, or in the form of an immunotoxin, antibody-drug
conjugate, or chimeric antigen receptor.
Upon the expiration or termination of the exclusive start-up option
license, Oncolinx Pharmaceuticals, LLC 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 May
19, 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: 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.
[[Page 25310]]
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: April 27, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-10276 Filed 5-1-15; 8:45 am]
BILLING CODE 4140-01-P
