80 FR 25309 - 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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 85 (May 4, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 85 (May 4, 2015)
| Page Range | 25309-25310 | |
| FR Document | 2015-10276 |
[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)] [Notices] [Pages 25309-25310] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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
![Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices 25309
DEPARTMENT OF HEALTH AND MSC 7844, Bethesda, MD 20892, (301) 408– practice the inventions embodied in
HUMAN SERVICES 9664, bishopj@csr.nih.gov. U.S. Patent Application 61/706,396
Name of Committee: Center for Scientific entitled ‘‘Mesothelin Antibodies And
National Institutes of Health Review Special Emphasis Panel; PAR Panel: Methods For Eliciting Potent Antitumor
Pilot Clinical Studies in Nephrology and Activity’’ [HHS Ref. E–236–2012/0–US–
Center for Scientific Review Notice of Urology.
Date: June 2–3, 2015.
01], PCT Application PCT/US2013/
Closed Meetings 059883 entitled ‘‘Mesothelin Antibodies
Time: 9:00 a.m. to 6:00 p.m.
Pursuant to section 10(d) of the Agenda: To review and evaluate grant And Methods For Eliciting Potent
Federal Advisory Committee Act, as applications. Antitumor Activity’’ [HHS Ref. E–236–
amended (5 U.S.C. App.), notice is Place: National Institutes of Health, 6701 2012/0–PCT–02], and all related
hereby given of the following meetings. Rockledge Drive, Bethesda, MD 20892, continuing and foreign patents/patent
(Virtual Meeting). applications for the technology family,
The meetings will be closed to the
Contact Person: Atul Sahai, Ph.D., to Oncolinx Pharmaceuticals, LLC. The
public in accordance with the Scientific Review Officer, Center for
provisions set forth in sections Scientific Review, National Institutes of
patent rights in these inventions have
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Health, 6701 Rockledge Drive, Room 2188, been assigned to and/or exclusively
as amended. The grant applications and MSC 7818, Bethesda, MD 20892, 301–435– licensed to the Government of the
the discussions could disclose 1198, sahaia@csr.nih.gov. United States of America.
confidential trade secrets or commercial Name of Committee: Center for Scientific The prospective exclusive start-up
property such as patentable material, Review Special Emphasis Panel; Temporal option licensed territory may be
and personal information concerning dynamics of Neurophysiological Patterns as worldwide, and the field of use may be
individuals associated with the grant Potential Targets for Treating Cognitive limited to:
Deficits in Brain Disorders. The use of bispecific antibodies
applications, the disclosure of which
Date: June 2, 2015 having:
would constitute a clearly unwarranted Time: 10:00 a.m. to 6:00 p.m.
invasion of personal privacy. (a) The complementary determining
Agenda: To review and evaluate grant
regions (CDRs) of the monoclonal
Name of Committee: Cell Biology applications.
Place: National Institutes of Health, 6701 antibody SD1; and
Integrated Review Group; Molecular and (b) the CDRs of an anti-CD3 antibody,
Integrative Signal Transduction Study Rockledge Drive, Bethesda, MD 20892,
Section. (Virtual Meeting). for the treatment of mesothelin-
Date: June 1–2, 2015. Contact Person: Wei-Qin Zhao, Ph.D., expressing cancers. The Licensed Field
Time: 8:00 a.m. to 5:30 p.m. Scientific Review Officer, Center for of Use explicitly excludes the use of the
Agenda: To review and evaluate grant Scientific Review, National Institutes of CDR sequences of SD1 in a
applications. Health, 6701 Rockledge Drive, Room 5181 monospecific antibody, or in the form of
Place: Embassy Suites at the Chevy Chase MSC 7846, Bethesda, MD 20892–7846, 301– an immunotoxin, antibody-drug
Pavilion, 4300 Military Road, NW., 435–1236, zhaow@csr.nih.gov.
conjugate, or chimeric antigen receptor.
Washington, DC 20015. (Catalogue of Federal Domestic Assistance Upon the expiration or termination of
Contact Person: Raya Mandler, Ph.D., Program Nos. 93.306, Comparative Medicine;
the exclusive start-up option license,
Scientific Review Officer, Center for 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844, Oncolinx Pharmaceuticals, LLC will
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5134, 93.846–93.878, 93.892, 93.893, National have the exclusive right to execute an
MSC 7840, Bethesda, MD 20892, (301) 402– Institutes of Health, HHS) exclusive commercialization license
8228, rayam@csr.nih.gov. Dated: April 28, 2015.
which will supersede and replace the
Name of Committee: Cardiovascular and exclusive start-up option license with
Michelle Trout,
Respiratory Sciences Integrated Review no greater field of use and territory than
Program Analyst, Office of Federal Advisory granted in the exclusive start-up option
Group; Lung Cellular, Molecular, and
Committee Policy.
Immunobiology Study Section license.
Date: June 2–3, 2015. [FR Doc. 2015–10273 Filed 5–1–15; 8:45 am]
DATES: Only written comments and/or
Time: 7:00 a.m. to 6:00 p.m. BILLING CODE 4140–01–P
applications for a license which are
Agenda: To review and evaluate grant
applications.
received by the NIH Office of
Place: Pier 5 Hotel, 711 Eastern Avenue, DEPARTMENT OF HEALTH AND Technology Transfer on or before May
Baltimore, MD 21202. HUMAN SERVICES 19, 2015 will be considered.
Contact Person: George M Barnas, Ph.D., ADDRESSES: Requests for copies of the
Scientific Review Officer, Center for National Institutes of Health patent application, inquiries, comments,
Scientific Review, National Institutes of and other materials relating to the
Health, 6701 Rockledge Drive, Room 2180, Prospective Grant of Exclusive Option contemplated exclusive license should
MSC 7818, Bethesda, MD 20892, 301–435– License: The Development of a Single be directed to: David A. Lambertson,
0696, barnasg@csr.nih.gov.
Domain Human Anti-Mesothelin Ph.D., Senior Licensing and Patenting
Name of Committee: Integrative, Monoclonal Antibody as a Bispecific Manager, Office of Technology Transfer,
Functional and Cognitive Neuroscience
Antibody for the Treatment of Human National Institutes of Health, 6011
Integrated Review Group; Sensorimotor
Integration Study Section. Cancers. Executive Boulevard, Suite 325,
Date: June 2, 2015. AGENCY: National Institutes of Health, Rockville, MD 20852–3804; Telephone:
Time: 8:00 a.m. to 6:00 p.m. HHS. (301) 435–4632; Facsimile: (301) 402–
Agenda: To review and evaluate grant 0220; Email: lambertsond@mail.nih.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES
applications. ACTION: Notice.
SUPPLEMENTARY INFORMATION: This
Place: Embassy Suites DC Convention SUMMARY: This is notice, in accordance invention concerns a monoclonal
Center, 900 10th Street, Washington, DC
20001.
with 35 U.S.C. 209 and 37 CFR part 404, antibody and methods of using the
Contact Person: John Bishop, Ph.D., that the National Institutes of Health, antibody for the treatment of
Scientific Review Officer, Center for Department of Health and Human mesothelin-expressing cancers,
Scientific Review, National Institutes of Services, is contemplating the grant of including mesothelioma, lung cancer,
Health, 6701 Rockledge Drive, Room 5182, an exclusive start-up option license to ovarian cancer and pancreatic cancer.
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![25310 Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices
The specific antibody covered by this groundings; Inland Rules of the Road; and International vessel navigation
technology is designated SD1, which is International Rules of the Road; Rules of the Road, aids to maritime
a single domain, fully human navigation regulations and equipment; navigation, maritime law, vessel safety,
monoclonal antibody against routing measures; marine information; port safety, or commercial diving safety.
mesothelin. diving safety; and aids to navigation Each member will be appointed to
Mesothelin is a cell surface antigen systems. represent the viewpoints and interests
that is preferentially expressed on DATES: Completed applications should of one of the following groups or
certain types of cancer cells. The SD1 reach the Coast Guard on or before June organizations, and at least one member
antibody can selectively bind to these 30, 2015. will be appointed to represent each
cancer cells and induce cell death while membership category:
ADDRESSES: Applicants should send a
leaving healthy, essential cells a. Commercial vessel owners or
unharmed. This can result in an cover letter expressing interest in an operators;
effective therapeutic strategy with fewer appointment to the Navigation Safety b. Professional mariners;
side effects due to less non-specific Advisory Council that also indentifies c. Recreational boaters;
killing of cells. which membership category the d. The recreational boating industry;
The prospective exclusive start-up applicant is applying under, along with e. State agencies responsible for vessel
option license will be royalty bearing the resume detailing the applicant’s or port safety; and
and will comply with the terms and experience via one of the following f. The Maritime Law Association.
conditions of 35 U.S.C. 209 and 37 CFR methods: Members serve as representatives and
• By mail: Commandant (CG–NAV)/ are not Special Government Employees
part 404. The prospective exclusive
NAVSAC Attn: Mr. George Detweiler, as defined in section 202(a) of Title 18,
start-up option license may be granted
Alternate Designated Federal Officer, U.S.C.
unless the NIH receives written
Commandant (CG–NAV), U.S. Coast The Coast Guard will consider
evidence and argument that establishes
Guard 2703 Martin Luther King Avenue applications for seven positions that
that the grant of the license would not
SE., STOP 7418, Washington, DC expire or become vacant on November
be consistent with the requirements of
20593–7418; 4, 2015, in the following categories:
35 U.S.C. 209 and 37 CFR part 404
• By fax to 202–372–1991; or a. Professional mariners;
within fifteen (15) days from the date of
• By email to George.H.Detweiler@ b. Recreational boaters;
this published notice.
uscg.mil. c. Recreational Boating Industry; and
Complete applications for a license in d. State agencies responsible for
the field of use filed in response to this FOR FURTHER INFORMATION CONTACT: Mr.
George Detweiler, the Navigation Safety vessel or port safety;
notice will be treated as objections to To be eligible, you should have
the grant of the contemplated exclusive Advisory Council Alternate Designated
experience in one of the categories
start-up option license. Comments and Federal Officer, telephone 202–372–
listed above. Members serve terms of
objections submitted to this notice will 1566, fax 202–372–1991, or email
office of up to three (3) years. Members
not be made available for public George.H.Detweiler@uscg.mil; or Mr.
may be reappointed to an additional
inspection and, to the extent permitted Burt Lahn, Navigation Safety Advisory
term, serving not more than six
by law, will not be released under the Council coordinator, telephone 202–
consecutive years. In the event the
Freedom of Information Act, 5 U.S.C. 372–1526, or email Burt.A.Lahn@
Navigation Safety Advisory Council
552. uscg.mil.
terminates, all appointments to the
Dated: April 27, 2015. SUPPLEMENTARY INFORMATION: The Council terminate.
Richard U. Rodriguez, Navigation Safety Advisory Council is a The Department of Homeland
Acting Director, Office of Technology federal advisory committee authorized Security does not discriminate in
Transfer, National Institutes of Health. by 33 U.S.C. 2073 and chartered under selection of Council members on the
[FR Doc. 2015–10276 Filed 5–1–15; 8:45 am] the Federal Advisory Committee Act, (5 basis of race, color, religion, sex,
BILLING CODE 4140–01–P
U.S.C. Appendix). The Navigation national origin, political affiliation,
Safety Advisory Council provides sexual orientation, gender identity,
advice and recommendations to the marital status, disabilities and genetic
DEPARTMENT OF HOMELAND Secretary, through the Commandant of information, age, membership in an
SECURITY the U.S. Coast Guard, on matters employee organization, or any other
relating to maritime collisions, non-merit factor. The Department of
Coast Guard rammings, and groundings; Inland Rules Homeland Security strives to achieve a
of the Road; International Rules of the widely diverse candidate pool for all of
[Docket No. USCG–2015–0042] Road; navigation regulations and its recruitment actions.
equipment; routing measures; marine If you are interested in applying to
Navigation Safety Advisory Council;
information; diving safety; and aids to become a member of the Council,
Vacancies
navigation systems. submit your cover letter and resume to
AGENCY: Coast Guard, DHS. The Navigation Safety Advisory Mr. George Detweiler, the Navigation
ACTION: Request for applications. Council is expected to meet at least Safety Advisory Council Alternate
twice each year, or more often with the Designated Federal Officer by email or
SUMMARY: The Coast Guard seeks approval of the Designated Federal mail according to instructions in the
mstockstill on DSK4VPTVN1PROD with NOTICES
applications for membership on the Officer. All members serve at their own ADDRESSES section by the deadline in
Navigation Safety Advisory Council. expense and receive no salary from the the DATES section of this notice.
The Navigation Safety Advisory Council Federal Government, although travel All email submittals will receive
provides advice and recommendations reimbursement and per diem may be email receipt confirmation.
to the Secretary of Homeland Security, provided for called meetings. The To visit our online docket, go to
through the Commandant of the U.S. Navigation Safety Advisory Council is https://www.regulations.gov. Enter the
Coast Guard, on matters relating to composed of not more than 21 members docket number for this notice (USCG–
maritime collisions, rammings, and who all will have expertise in Inland 2015–0042) in the Search box, and click
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Document Created: 2018-02-21 10:22:47
Document Modified: 2018-02-21 10:22:47
| 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 NIH Office of Technology Transfer on or before May 19, 2015 will be considered. | |
| FR Citation | 80 FR 25309 |
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