Prospective Grant of Exclusive Patent License: The Development of a Bispecific, Biparatopic Antibody-Drug Conjugate to GPC3 for the Treatment of Human Liver Cancers, 36808-36809 [2017-16525]
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36808
Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Asthma and Allergic
Diseases Cooperative Research Centers.
Date: September 7–14, 2017.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The William F. Bolger Center, 9600
Newbridge Drive, Potomac, MD 20854.
Contact Person: Paul A. Amstad, Ph.D.,
Scientific Review Officer, Scientific Review
Program, NIAID/NIH/DHHS, Division of
Extramural Activities, Room 3G41, 5601
Fishers Lane, Bethesda, MD 20892–7616,
240–669–5067, pamstad@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: August 1, 2017.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–16522 Filed 8–4–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: The Development of a
Bispecific, Biparatopic Antibody-Drug
Conjugate to GPC3 for the Treatment
of Human Liver Cancers
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute,
National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an Exclusive Patent License to Salubris
Biotherapeutics, Inc. (Salubris), located
in Gaithersburg, Maryland, to practice
the inventions embodied in the patent
applications listed in the
SUPPLEMENTARY INFORMATION section of
this notice.
DATES: Only written comments and/or
applications for a license which are
received by the NCI Technology
Transfer Center on or before August 22,
2017 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: David A. Lambertson, Ph.D.,
Senior Licensing and Patenting
Manager, NCI Technology Transfer
Center, 9609 Medical Center Drive, RM
mstockstill on DSK30JT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:14 Aug 04, 2017
Jkt 241001
1E530 MSC 9702, Bethesda, MD 20892–
9702 (for business mail), Rockville, MD
20850–9702; Telephone: (240) 276–
6467; Email: david.lambertson@nih.gov.
SUPPLEMENTARY INFORMATION: The
following represents the intellectual
property to be licensed under the
prospective agreement: (A) U.S.
Provisional Patent Application 61/
654,232 entitled ‘‘High-affinity
Monoclonal Antibodies To Glypican-3
And Use Thereof’’ [HHS Ref. E–136–
2012/0–US–01], PCT Patent Application
PCT/US2013/043633 entitled ‘‘Highaffinity Monoclonal Antibodies To
Glypican-3 And Use Thereof’’ [HHS Ref.
E–136–2012/0–PCT–02], Chinese Patent
Application 201380039993.7 entitled
‘‘High-affinity Monoclonal Antibodies
To Glypican-3 And Use Thereof’’ [HHS
Ref. E–136–2012/0–CN–03], Japanese
Patent Application 2015–515243
entitled ‘‘High-affinity Monoclonal
Antibodies To Glypican-3 And Use
Thereof’’ [HHS Ref. E–136–2012/0–JP–
04], South Korean Patent Application
10–2014–7037046 entitled ‘‘Highaffinity Monoclonal Antibodies To
Glypican-3 And Use Thereof’’ [HHS Ref.
E–136–2012/0–KR–05], Singapore
Patent Application 11201407972R
entitled ‘‘High-affinity Monoclonal
Antibodies To Glypican-3 And Use
Thereof’’ [HHS Ref. E–136–2012/0–SG–
06], and United States Patent 9,409,994
entitled ‘‘High-affinity Monoclonal
Antibodies To Glypican-3 And Use
Thereof’’ [HHS Ref. E–136–2012/0–US–
07], and all continuing U.S. and foreign
patents/patent applications for the
technology family; and (B) U.S.
Provisional Patent Application 61/
477,020 entitled ‘‘Human Monoclonal
Antibody Specific for Glypican-3 And
Use Thereof’’ [HHS Ref. E–130–2011/0–
US–01], PCT Patent Application PCT/
US2012/034186 entitled ‘‘Human
Monoclonal Antibodies Specific for
Glypican-3 And Use Thereof’’ [HHS Ref.
E–130–2011/0–PCT–02], Chinese Patent
201280029201.3 entitled ‘‘Human
Monoclonal Antibodies Specific for
Glypican-3 And Use Thereof’’ [HHS Ref.
E–130–2011/0–CN–03], European Patent
2699603 entitled ‘‘Human Monoclonal
Antibodies Specific for Glypican-3 And
Use Thereof’’ [HHS Ref. E–130–2011/0–
EP–04], and validated in France [HHS
Ref. E–130–2011/0–FR–09], Germany
[HHS Ref. E–130–2011/0–DE–08] and
the United Kingdom [HHS Ref. E–130–
2011/0–GB–10] and lodged in Hong
Kong [HHS Ref. E–130–2011/0–HK–11],
United States Patent 9,206,257 entitled
‘‘Human Monoclonal Antibodies
Specific for Glypican-3 And Use
Thereof’’ [HHS Ref. E–130–2011/0–US–
05], United States Patent 9,394,364,
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
entitled ‘‘Human Monoclonal
Antibodies Specific for Glypican-3 And
Use Thereof’’ [HHS Ref. E–130–2011/0–
US–06], European Patent Application
15188264.4 entitled ‘‘Human
Monoclonal Antibodies Specific for
Glypican-3 And Use Thereof’’ [HHS Ref.
E–130–2011/0–EP–07], United States
Patent Application 15/090,873 entitled
‘‘Human Monoclonal Antibodies
Specific for Glypican-3 And Use
Thereof’’ [HHS Ref. E–130–2011/0–US–
12], Chinese Patent Application
201610290837.3 entitled ‘‘Human
Monoclonal Antibodies Specific for
Glypican-3 And Use Thereof’’ [HHS Ref.
E–130–2011/0–CN–13], European Patent
Application 16166924.7 entitled
‘‘Human Monoclonal Antibodies
Specific for Glypican-3 And Use
Thereof’’ [HHS Ref. E–130–2011/0–EP–
14], and all continuing U.S. and foreign
patents/patent applications for the
technology family, to Salubris. The
patent rights in these inventions have
been assigned to and/or exclusively
licensed to the Government of the
United States of America.
With respect to persons who have an
obligation to assign their right, title and
interest to the Government of the United
States of America, the patent rights in
these inventions have been assigned to
the Government of the United States of
America.
The prospective Exclusive Patent
License territory may be worldwide for
the following field of use:
The development and commercialization
of a bispecific, biparatopic antibody-drug
conjugate (ADC) having:
(1) The CDR sequences of both the hYP7
and HN3 anti-GPC3 monoclonal antibodies;
and
(2) a microtubule inhibitor payload
including, but not limited to, auristatin and
mertansine;
for the treatment of human liver cancer. The
licensed field of use excludes any (a) nonspecified immunoconjugates, including, but
not limited to, chimeric antigen receptors
(CARs) and variants thereof, immunotoxins,
ADCs with payloads that are not microtubule
inhibitors, and monospecific versions of the
aforementioned immunoconjugates, and (b)
unconjugated antibodies.
The present inventions to be licensed
concern monoclonal antibodies that are
specific for the cell surface domain of
GPC3: HN3 and hYP7. These antibodies
can potentially be used for the treatment
of GPC3-expressing cancers such as
HCC. In the subject situation, the
antibodies can be used in conjunction to
target a toxic payload specifically to
GPC3-expressing cells, leading to the
selective destruction of the cancerous
cells.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
E:\FR\FM\07AUN1.SGM
07AUN1
Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
The prospective Exclusive Patent
License will be royalty bearing and 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.
Complete applications for a license in
the prospective field of use that are
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated Exclusive Patent
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: July 25, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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.
mstockstill on DSK30JT082PROD with NOTICES
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: MicroRNA Therapeutics for
Treating Squamous Cell Carcinomas
AGENCY:
National Institutes of Health,
Notice.
The National Heart, Lung and
Blood Institute (NHLBI), National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an Exclusive
Patent License to MiRecule, Inc., located
in Rockville, Maryland, to practice the
inventions embodied in the patent
applications listed in the
SUPPLEMENTARY INFORMATION section of
this notice.
DATES: Only written comments and/or
applications for a license which are
received by the NHLBI Office of
Technology Transfer and Development
August 22, 2017 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Michael Shmilovich, Esq.,
Senior Licensing and Patent Manager,
31 Center Drive, Room 4A29, MSC2479,
Bethesda, MD 20892–2479, phone
number 301–435–5019, or shmilovm@
mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
following represents the intellectual
property to be licensed under the
prospective agreement: HHS Ref. No. E–
043–2016/0, including provisional
patent application 62/304,844 filed
March 7, 2016 and International Patent
Application PCT/US2017/021178 filed
March 7, 2017 both entitled
‘‘MicroRNAs And Methods Of Their
Use,’’ and all continuing U.S. and
foreign patents/patent applications for
the technology family, to MiRecule. The
patent rights in these inventions have
been assigned to and/or exclusively
licensed to the Government of the
United States of America.
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Name of Committee: National Institute on
Aging Special Emphasis Panel; Drugs
Targeting Pathways of Aging.
Date: September 13, 2017.
Time: 3:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 2W200, 7201 Wisconsin
Avenue, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Anita H. Undale, Ph.D.,
MD, Scientific Review Branch, National
Institute on Aging, Gateway Building, Suite
2W200, 7201 Wisconsin Avenue, Bethesda,
Jkt 241001
[FR Doc. 2017–16521 Filed 8–4–17; 8:45 am]
ACTION:
BILLING CODE 4140–01–P
18:14 Aug 04, 2017
Dated: August 1, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
HHS.
[FR Doc. 2017–16525 Filed 8–4–17; 8:45 am]
VerDate Sep<11>2014
MD 20892, 240–747–7825, anita.undale@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
PO 00000
Frm 00082
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36809
With respect to persons who have an
obligation to assign their right, title and
interest to the Government of the United
States of America, the patent rights in
these inventions have been assigned to
the Government of the United States of
America.
The prospective Exclusive Patent
License territory may be worldwide for
the following field of use: MicroRNA
therapeutics for squamous cell
carcinomas.
The invention relates to the use of
microRNAs (miRs), miR mimics, miR
mimetics, and a combination thereof as
anti-proliferative cancer therapeutics. In
this case, miRs will be administered in
a form complexed with nanoparticles in
the form of liposomes decorated with
anti-transferrin receptor (TfR) scFv
fragments. Generally, miRs are a highly
conserved class of small RNA molecules
(about 18–24bp) that primarily bind the
3’-UTR region of mRNA molecules and
either block translation or promote
nuclease mediated degradation. The
inventors found that mimics or
mimetics derived from several members
of the miR–30–5p family; and miR–30a–
5p and miR–30e–5p, have potential as
anti-proliferative therapeutics in cancers
including but not limited to squamous
cell carcinomas and currently have a
CRADA with NIDCD exploring their
uses in treating head and neck
squamous cell carcinoma (HNSSC). In
an in vivo proof-of-concept using a
murine xenograft tumor model for
HNSSC, the inventors demonstrated that
intraperitoneal administration of a
nanoliposome formulated with an antitransferrin receptor antibody fragment
and a synthetic miR–30a–5p mimic
strongly delayed tumor growth. Other
anti-cancer miR therapeutic mimics can
be combines with miR–30 including
miR–145–5p, miR–26a–5p, miR–26b–
5p, miR–375–5p, miR–30b–5p, miR–
30d–5p, or miR–338–3p. Modes of
administration can be by intravenous
injection, intraperitoneal injection,
subcutaneous injection, or intratumoral
injection. Therapeutic design employing
miR mimicry focuses on nucleic acid
modifications that exhibit better
cytotoxicity than unmodified miRs or
commercially available mimics. For
example, it is accepted that
modification of the 2’ position of
individual nucleic acids in an
oligonucleotide can improve affinity to
complementary strands and confer
resistance to nucleases and reduce
adverse immunogenic reactions. By way
of another example, bases 1, 6, and 20
of a passenger strand miR can be
mutated to increase the stability of the
resulting duplex; however, these
mutation sites may differ from one
E:\FR\FM\07AUN1.SGM
07AUN1
]]>Agencies
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36808-36809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16525]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: The Development of
a Bispecific, Biparatopic Antibody-Drug Conjugate to GPC3 for the
Treatment of Human Liver Cancers
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Cancer Institute, National Institutes of Health,
Department of Health and Human Services, is contemplating the grant of
an Exclusive Patent License to Salubris Biotherapeutics, Inc.
(Salubris), located in Gaithersburg, Maryland, to practice the
inventions embodied in the patent applications listed in the
SUPPLEMENTARY INFORMATION section of this notice.
DATES: Only written comments and/or applications for a license which
are received by the NCI Technology Transfer Center on or before August
22, 2017 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated Exclusive Patent License
should be directed to: David A. Lambertson, Ph.D., Senior Licensing and
Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center
Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail),
Rockville, MD 20850-9702; Telephone: (240) 276-6467; Email:
david.lambertson@nih.gov.
SUPPLEMENTARY INFORMATION: The following represents the intellectual
property to be licensed under the prospective agreement: (A) U.S.
Provisional Patent Application 61/654,232 entitled ``High-affinity
Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-
2012/0-US-01], PCT Patent Application PCT/US2013/043633 entitled
``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof''
[HHS Ref. E-136-2012/0-PCT-02], Chinese Patent Application
201380039993.7 entitled ``High-affinity Monoclonal Antibodies To
Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-CN-03], Japanese
Patent Application 2015-515243 entitled ``High-affinity Monoclonal
Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-JP-
04], South Korean Patent Application 10-2014-7037046 entitled ``High-
affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS
Ref. E-136-2012/0-KR-05], Singapore Patent Application 11201407972R
entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use
Thereof'' [HHS Ref. E-136-2012/0-SG-06], and United States Patent
9,409,994 entitled ``High-affinity Monoclonal Antibodies To Glypican-3
And Use Thereof'' [HHS Ref. E-136-2012/0-US-07], and all continuing
U.S. and foreign patents/patent applications for the technology family;
and (B) U.S. Provisional Patent Application 61/477,020 entitled ``Human
Monoclonal Antibody Specific for Glypican-3 And Use Thereof'' [HHS Ref.
E-130-2011/0-US-01], PCT Patent Application PCT/US2012/034186 entitled
``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof''
[HHS Ref. E-130-2011/0-PCT-02], Chinese Patent 201280029201.3 entitled
``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof''
[HHS Ref. E-130-2011/0-CN-03], European Patent 2699603 entitled ``Human
Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS
Ref. E-130-2011/0-EP-04], and validated in France [HHS Ref. E-130-2011/
0-FR-09], Germany [HHS Ref. E-130-2011/0-DE-08] and the United Kingdom
[HHS Ref. E-130-2011/0-GB-10] and lodged in Hong Kong [HHS Ref. E-130-
2011/0-HK-11], United States Patent 9,206,257 entitled ``Human
Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS
Ref. E-130-2011/0-US-05], United States Patent 9,394,364, entitled
``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof''
[HHS Ref. E-130-2011/0-US-06], European Patent Application 15188264.4
entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use
Thereof'' [HHS Ref. E-130-2011/0-EP-07], United States Patent
Application 15/090,873 entitled ``Human Monoclonal Antibodies Specific
for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-12], Chinese
Patent Application 201610290837.3 entitled ``Human Monoclonal
Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-
2011/0-CN-13], European Patent Application 16166924.7 entitled ``Human
Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS
Ref. E-130-2011/0-EP-14], and all continuing U.S. and foreign patents/
patent applications for the technology family, to Salubris. The patent
rights in these inventions have been assigned to and/or exclusively
licensed to the Government of the United States of America.
With respect to persons who have an obligation to assign their
right, title and interest to the Government of the United States of
America, the patent rights in these inventions have been assigned to
the Government of the United States of America.
The prospective Exclusive Patent License territory may be worldwide
for the following field of use:
The development and commercialization of a bispecific,
biparatopic antibody-drug conjugate (ADC) having:
(1) The CDR sequences of both the hYP7 and HN3 anti-GPC3
monoclonal antibodies; and
(2) a microtubule inhibitor payload including, but not limited
to, auristatin and mertansine;
for the treatment of human liver cancer. The licensed field of use
excludes any (a) non-specified immunoconjugates, including, but not
limited to, chimeric antigen receptors (CARs) and variants thereof,
immunotoxins, ADCs with payloads that are not microtubule
inhibitors, and monospecific versions of the aforementioned
immunoconjugates, and (b) unconjugated antibodies.
The present inventions to be licensed concern monoclonal antibodies
that are specific for the cell surface domain of GPC3: HN3 and hYP7.
These antibodies can potentially be used for the treatment of GPC3-
expressing cancers such as HCC. In the subject situation, the
antibodies can be used in conjunction to target a toxic payload
specifically to GPC3-expressing cells, leading to the selective
destruction of the cancerous cells.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404.
[[Page 36809]]
The prospective Exclusive Patent License will be royalty bearing and
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.
Complete applications for a license in the prospective field of use
that are timely filed in response to this notice will be treated as
objections to the grant of the contemplated Exclusive Patent 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: July 25, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2017-16525 Filed 8-4-17; 8:45 am]
BILLING CODE 4140-01-P
