Prospective Grant of Exclusive Patent License: The Development of an Anti-Mesothelin Recombinant Immunotoxin (RIT) for the Treatment of Human Cancers., 11926-11927 [2017-03823]
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Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Notices
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Sickle Cell Disease
Advisory Committee.
Date: March 29, 2017.
Time: 8:30 a.m. to 1:45 p.m.
Agenda: Presentations and Discussion of
Training the Next Generation of Researchers
in Sickle Cell Disease.
Place: National Institutes of Health 6701
Rockledge Drive, 9th Floor, Room 9100/9104,
Bethesda, MD 20892.
Contact Person: W. Keith Hoots, MD,
Director, Division of Blood Diseases and
Resources, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Suite 9030,
Bethesda, MD 20892, 301–435–0080,
hootswk@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: February 21, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–03706 Filed 2–24–17; 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 an AntiMesothelin Recombinant Immunotoxin
(RIT) for the Treatment of Human
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 Selecta
Biosciences (‘‘Selecta’’) located in
Watertown, Massachusetts 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 March 14,
2017 will be considered.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
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20:23 Feb 24, 2017
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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: lambertsond@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
following represents the intellectual
property to be licensed under the
prospective agreement:
ADDRESSES:
U.S. Patent Application 61/535,668 (HHS
Ref. E–263–2011/0–US–01), PCT
Application PCT/US2012/055034 (HHS
reference E–263–2011/0–PCT–02),
Australian Patent Application 2012308591
(HHS reference E–263–2011/0–AU–03),
Canadian Patent Application 2846608
(HHS reference E–263–2011/0–CA–04),
European Patent Application 12766780.6
(HHS reference E–263–2011/0–EP–05), US
Patent 9,206,240 (HHS reference E–263–
2011/0–US–06), Hong Kong Patent
Application 14111650.2 (HHS reference E–
263–2011/0–HK–07), and US Patent
Application 14/927,645 (HHS reference E–
263–2011/0–US–08);
U.S. Patent Application 61/495,085 (HHS
Ref. E–174–2011/0–US–01), PCT
Application PCT/US2012/041234 (HHS
reference E–174–2011/0–PCT–02),
Australian Patent Application 2012268013
(HHS reference E–174–2011/0–AU–03),
Brazilian Patent Application
112013031262–9 (HHS reference E–174–
2011/0–BR–04), Canadian Patent
Application 2838013 (HHS reference E–
174–2011/0–CA–05), Chinese Patent
Application 201280039071.1 (HHS
reference E–174–2011/0–CN–06), European
Patent Application 12727074.2 (HHS
reference E–174–2011/0–EP–07), Hong
Kong Patent Application 14105911.9 (HHS
reference E–174–2011/0–HK–08), Japanese
Patent Application 2014–514616 (HHS
reference E–174–2011/0–JP–09), South
Korean Patent Application 2013–7032402
(HHS reference E–174–2011/0–KR–10),
Mexican Patent Application MX/a/2013/
014388 (HHS reference E–174–2011/0–
MX–11), Russian Patent Application
2013151655 (HHS reference E–174–2011/
0–RU–12), US Patent 9,346,859 (HHS
reference E–174–2011/0–US–13), Hong
Kong Patent Application 14106689.7 (HHS
reference E–174–2011/0–HK–14), and US
Patent Application 15/095,470 (HHS
reference E–174–2011/0–US–15);
U.S. Patent Application 61/483,531 (HHS
Ref. E–117–2011/0–US–01), PCT
Application PCT/US2012/036456 (HHS
reference E–117–2011/0–PCT–02),
Australian Patent Application 2012253896
(HHS reference E–117–2011/0–AU–03),
Brazilian Patent Application
112013028537–0 (HHS reference E–117–
2011/0–BR–04), Canadian Patent
Application 2835070 (HHS reference E–
117–2011/0–CA–05), Chilean Patent
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Application 03182–2013 (HHS reference
E–117–2011/0–CL–06), Ecuadorian Patent
Application SP–13–13067 (HHS reference
E–117–2011/0–EC–07), Egyptian Patent
Application PCT 1697/2013 (HHS
reference E–117–2011/0–EG–08), European
Patent Application 12722586.0 (HHS
reference E–117–2011/0–EP–09), Hong
Kong Patent Application 14105586.3 (HHS
reference E–117–2011/0–HK–10), South
Korean Patent Application 2013–7032247
(HHS reference E–117–2011/0–KR–11),
Mexican Patent Application MX/a/2013/
012905 (HHS reference E–117–2011/0–
MX–12), Malaysian Patent Application
PI2013702094 (HHS reference E–117–
2011/0–MY–13), New Zealand Patent
Application 617386 (HHS reference E–
117–2011/0–NZ–14), Philippines Patent
Application 1–2013–502264 (HHS
reference E–117–2011/0–PH–15), Russian
Patent Application 2013148919 (HHS
reference E–117–2011/0–RU–16),
Singapore Patent Application 201308179–
9 (HHS reference E–117–2011/0–SG–17),
Thailand Patent Application 1301006329
(HHS reference E–117–2011/0–TH–18),
Ukrainian Patent Application 201313011
(HHS reference E–117–2011/0–UA–19),
Vietnamese Patent Application 1–2013–
03855 (HHS reference E–117–2011/0–VN–
20), South African Patent Application
2013/08270 (HHS reference E–117–2011/
0–ZA–21), US Patent Application 14/
115,131 (HHS reference E–117–2011/0–
US–22), Japanese Patent Application 2014–
509467 (HHS reference E–117–2011/0–JP–
23), Chinese Patent 201280033583.7 (HHS
reference E–117–2011/0–CN–24),
Colombian Patent Application 13–274.153
(HHS reference E–117–2011/0–CO–25),
Costa Rican Patent Application 2013–0571
(HHS reference E–117–2011/0–CR–26),
Indonesian Patent Application W–
00201305198 (HHS reference E–117–2011/
0–ID–27), Israeli Patent Application
229198 (HHS reference E–117–2011/0–IL–
28), Indian Patent Application 8854/
CHENP/2013 (HHS reference E–117–2011/
0–IN–29), Peruvian Patent Application
2456.13 (HHS reference E–117–2011/0–
PE–30), Algerian Patent Application
130758 (HHS reference E–117–2011/0–DZ–
31), Moroccan Patent Application 36534
(HHS reference E–117–2011/0–MA–32),
and Hong Kong Patent Application
14108273.5 (HHS reference E–117–2011/0–
HK–33);
U.S. Patent Application 61/241,620 (HHS
Ref. E–269–2009/0–US–01), PCT
Application PCT/US2010/048504 (HHS
reference E–269–2009/0–PCT–02),
Australian Patent 2010292069 (HHS
reference E–269–2009/0–AU–03),
Canadian Patent Application 2773665
(HHS reference E–269–2009/0–CA–04),
Chinese Patent 201080049559.3 (HHS
reference E–269–2009/0–CN–05), European
Patent 2475398 (HHS reference E–269–
2009/0–EP–06), as validated in France,
Germany, Italy, Spain and the United
Kingdom, Indian Patent Application 3197/
CHENP/2012 (HHS reference E–269–2009/
0–IN–07), Japanese Patent 5795765 (HHS
reference E–269–2009/0–JP–08), Russian
Patent Application 2012114005 (HHS
E:\FR\FM\27FEN1.SGM
27FEN1
mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Notices
reference E–269–2009/0–RU–09), and US
Patent 8,936,792 (HHS reference E–269–
2009/0–US–10);
U.S. Patent Application 60/969,929 (HHS
Ref. E–292–2007/0–US–01), PCT
Application PCT/US2008/075296 (HHS
reference E–292–2007/0–PCT–02),
Australian Patent 2008296194 (HHS
reference E–292–2007/0–AU–03),
Canadian Patent Application 2698357
(HHS reference E–292–2007/0–CA–04),
European Patent 2197903 (HHS reference
E–292–2007/0–EP–05) as validated in
Austria, Belgium, Bulgaria, Switzerland,
Cyprus, Germany, Denmark, Estonia,
Spain, Finland, France, the United
Kingdom, Greece, Croatia, Hungary,
Ireland, Italy, Lithuania, Luxembourg,
Latvia, Monaco, Malta, the Netherlands,
Norway, Poland, Portugal, Romania,
Slovenia, Slovakia, and Turkey, US Patent
8,871,906 (HHS reference E–292–2007/0–
US–06), European Patent Application
12184319.7 (HHS reference E–292–2007/0–
EP–07), and Hong Kong Patent Application
13106628.2 (HHS reference E–292–2007/0–
HK–08);
U.S. Patent Application 60/703,798 (HHS
Ref. E–262–2005/0–US–01), PCT
Application PCT/US2006/028986 (HHS
reference E–262–2005/0–PCT–02),
Australian Patent 2006275865 (HHS
reference E–262–2005/0–AU–03),
Canadian Patent 2616987 (HHS reference
E–262–2005/0–CA–04), European Patent
1910407 (HHS reference E–262–2005/0–
EP–05) as validated in Switzerland,
Germany, Spain, France, the United
Kingdom, and Italy, US Patent 8,907,060
(HHS reference E–262–2005/0–US–06),
European Patent 2311854 (HHS reference
E–262–2005/0–EP–07) as validated in
Switzerland, Germany, Spain, France, the
United Kingdom, and Italy, European
Patent 2332970 (HHS reference E–262–
2005/0–EP–08) as validated in Germany,
Spain, France, the United Kingdom, and
Italy, Australian Patent 2012216642 (HHS
reference E–262–2005/0–AU–15),
Australian Patent 2014208269 (HHS
reference E–262–2005/0–AU–22),
European Patent Application 15191388.6
(HHS reference E–262–2005/0–EP–28),
European Patent Application 15191391.0
(HHS reference E–262–2005/0–EP–29),
European Patent Application 15191395.1
(HHS reference E–262–2005/0–EP–30),
Australian Patent Application (HHS
reference E–262–2005/0–AU–31), and
Canadian Patent Application (HHS
reference E–262–2005/0–CA–32);
U.S. Patent Application 60/160,071 (HHS
Ref. E–139–1999/0–US–01), PCT
Application PCT/US00/14829 (HHS
reference E–139–1999/0–PCT–02),
Canadian Patent 2374398 (HHS reference
E–139–1999/0–CA–03), European Patent
1180123 (HHS reference E–139–1999/0–
EP–04) as validated in Belgium,
Switzerland, Germany, Denmark, France,
The United Kingdom, Italy, The
Netherlands, and Sweden, Japanese Patent
5683766 (HHS reference E–139–1999/0–
JP–05), Mexican Patent 270476 (HHS
reference E–139–1999/0–MX–06); and U.S.
Patent 7,081,518 (HHS reference E–139–
1999/0–US–07);
VerDate Sep<11>2014
20:23 Feb 24, 2017
Jkt 241001
U.S. Patent Application 60/067,175 (HHS
Ref. E–021–1998/0–US–01), PCT
Application PCT/US98/25270 (HHS
reference E–021–1998/0–PCT–02),
Australian Patent 760120 (HHS reference
E–021–1998/0–AU–03), Canadian Patent
2318576 (HHS reference E–021–1998/0–
CA–04), European Patent 1025230 (HHS
reference E–021–1998/0–EP–05) as
validated in Switzerland, Germany, France,
Italy, Spain and the United Kingdom,
Israeli Patent 135775 (HHS reference E–
021–1998/0–IL–06), US Patent 6,809,184
(HHS reference E–021–1998/0–US–07), US
Patent 7,368,110 (HHS reference E–021–
1998/0–US–08), and US Patent 7,709,252
(HHS reference E–021–1998/0–US–15),
U.S. Patent Application 60/010,166 (HHS
Ref. E–002–1996/0–US–01), PCT
Application PCT/US97/00224 (HHS Ref.
E–002–1996/1–PCT–01), U.S. Patent
6,083,502 (HHS reference E–002–1996/1–
US–02), Australian Patent 703769 (HHS
reference E–002–1996/1–AU–03),
Canadian Patent 2241604 (HHS reference
E–002–1996/1–CA–04), European Patent
0871492 (HHS reference E–002–1996/1–
EP–05) as validated in Switzerland,
Germany, France, Italy Spain and the
United Kingdom, U.S. Patent 6,153,430
(HHS reference E–002–1996/1–US–14),
and U.S. Patent 7,375,183 (HHS reference
E–002–1996/1–US–15);
and all continuing applications and
foreign counterparts.
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 use of anti-mesothelin targeted
immunotoxins for the treatment of
mesothelin-expressing cancers, wherein
the immunotoxins have:
(1) A targeting domain containing the
complementary determining regions
(CDRs) of the SS1 antibody; and
(2) A Pseudomonas exotoxin A (PE)
toxin domain that lacks at least one B
cell or T cell epitope due to the
alteration or deletion of one or more
amino acids.
For purposes of clarity, the
immunotoxin may include additional
alterations to B cell and T cell epitopes
for the reduction of immunogenicity, a
peptide linker sequence, and/or
polyethylene glycol molecule(s). The
immunotoxins may also be combined
with the use of synthetic vaccine
particle (SVP)-rapamycin.’’
The present inventions to be licensed
concern RITs which are targeted to
mesothelin-expressing cancer cells, and
methods of using the immunotoxins for
the treatment of mesothelin-expressing
cancers (such as mesothelioma, ovarian
PO 00000
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Fmt 4703
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11927
cancer and pancreatic cancer). The
specific immunotoxin will have an
antibody targeting domain that contains
the CDRs of the antibody identified as
SS1, which was invented at the NIH.
The specific immunotoxin will also
have a toxin domain derived from PE
that is resistant to lysosomal proteases
due to the deletion of a large portion of
the exotoxin, and which lacks at least
one major B-cell epitope due to the
alteration an amino acid. Ultimately, the
PE used in the immunotoxin may lack
multiple B-cell epitopes, as well as
multiple T-cell epitopes, in an effort to
minimize immunogenicity.
Alterations to the toxin that reduce
immunogenicity improve the
therapeutic value of the immunotoxin
while maintaining its ability to trigger
cell death. Since mesothelin is
preferentially expressed on certain types
of cancer cells, the immunotoxins
selectively bind and kill only those
cancer cells, allowing healthy, essential
cells to remain unharmed. This may
result in an effective therapeutic
strategy with fewer side effects,
especially when combined with agents
that can suppress the formation of
neutralizing antibodies.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
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: February 21, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2017–03823 Filed 2–24–17; 8:45 am]
BILLING CODE 4140–01–P
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Agencies
[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)]
[Notices]
[Pages 11926-11927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03823]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: The Development of
an Anti-Mesothelin Recombinant Immunotoxin (RIT) for the Treatment of
Human 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 Selecta Biosciences (``Selecta'')
located in Watertown, Massachusetts 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 March
14, 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:
lambertsond@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The following represents the intellectual
property to be licensed under the prospective agreement:
U.S. Patent Application 61/535,668 (HHS Ref. E-263-2011/0-US-01),
PCT Application PCT/US2012/055034 (HHS reference E-263-2011/0-PCT-
02), Australian Patent Application 2012308591 (HHS reference E-263-
2011/0-AU-03), Canadian Patent Application 2846608 (HHS reference E-
263-2011/0-CA-04), European Patent Application 12766780.6 (HHS
reference E-263-2011/0-EP-05), US Patent 9,206,240 (HHS reference E-
263-2011/0-US-06), Hong Kong Patent Application 14111650.2 (HHS
reference E-263-2011/0-HK-07), and US Patent Application 14/927,645
(HHS reference E-263-2011/0-US-08);
U.S. Patent Application 61/495,085 (HHS Ref. E-174-2011/0-US-01),
PCT Application PCT/US2012/041234 (HHS reference E-174-2011/0-PCT-
02), Australian Patent Application 2012268013 (HHS reference E-174-
2011/0-AU-03), Brazilian Patent Application 112013031262-9 (HHS
reference E-174-2011/0-BR-04), Canadian Patent Application 2838013
(HHS reference E-174-2011/0-CA-05), Chinese Patent Application
201280039071.1 (HHS reference E-174-2011/0-CN-06), European Patent
Application 12727074.2 (HHS reference E-174-2011/0-EP-07), Hong Kong
Patent Application 14105911.9 (HHS reference E-174-2011/0-HK-08),
Japanese Patent Application 2014-514616 (HHS reference E-174-2011/0-
JP-09), South Korean Patent Application 2013-7032402 (HHS reference
E-174-2011/0-KR-10), Mexican Patent Application MX/a/2013/014388
(HHS reference E-174-2011/0-MX-11), Russian Patent Application
2013151655 (HHS reference E-174-2011/0-RU-12), US Patent 9,346,859
(HHS reference E-174-2011/0-US-13), Hong Kong Patent Application
14106689.7 (HHS reference E-174-2011/0-HK-14), and US Patent
Application 15/095,470 (HHS reference E-174-2011/0-US-15);
U.S. Patent Application 61/483,531 (HHS Ref. E-117-2011/0-US-01),
PCT Application PCT/US2012/036456 (HHS reference E-117-2011/0-PCT-
02), Australian Patent Application 2012253896 (HHS reference E-117-
2011/0-AU-03), Brazilian Patent Application 112013028537-0 (HHS
reference E-117-2011/0-BR-04), Canadian Patent Application 2835070
(HHS reference E-117-2011/0-CA-05), Chilean Patent Application
03182-2013 (HHS reference E-117-2011/0-CL-06), Ecuadorian Patent
Application SP-13-13067 (HHS reference E-117-2011/0-EC-07), Egyptian
Patent Application PCT 1697/2013 (HHS reference E-117-2011/0-EG-08),
European Patent Application 12722586.0 (HHS reference E-117-2011/0-
EP-09), Hong Kong Patent Application 14105586.3 (HHS reference E-
117-2011/0-HK-10), South Korean Patent Application 2013-7032247 (HHS
reference E-117-2011/0-KR-11), Mexican Patent Application MX/a/2013/
012905 (HHS reference E-117-2011/0-MX-12), Malaysian Patent
Application PI2013702094 (HHS reference E-117-2011/0-MY-13), New
Zealand Patent Application 617386 (HHS reference E-117-2011/0-NZ-
14), Philippines Patent Application 1-2013-502264 (HHS reference E-
117-2011/0-PH-15), Russian Patent Application 2013148919 (HHS
reference E-117-2011/0-RU-16), Singapore Patent Application
201308179-9 (HHS reference E-117-2011/0-SG-17), Thailand Patent
Application 1301006329 (HHS reference E-117-2011/0-TH-18), Ukrainian
Patent Application 201313011 (HHS reference E-117-2011/0-UA-19),
Vietnamese Patent Application 1-2013-03855 (HHS reference E-117-
2011/0-VN-20), South African Patent Application 2013/08270 (HHS
reference E-117-2011/0-ZA-21), US Patent Application 14/115,131 (HHS
reference E-117-2011/0-US-22), Japanese Patent Application 2014-
509467 (HHS reference E-117-2011/0-JP-23), Chinese Patent
201280033583.7 (HHS reference E-117-2011/0-CN-24), Colombian Patent
Application 13-274.153 (HHS reference E-117-2011/0-CO-25), Costa
Rican Patent Application 2013-0571 (HHS reference E-117-2011/0-CR-
26), Indonesian Patent Application W-00201305198 (HHS reference E-
117-2011/0-ID-27), Israeli Patent Application 229198 (HHS reference
E-117-2011/0-IL-28), Indian Patent Application 8854/CHENP/2013 (HHS
reference E-117-2011/0-IN-29), Peruvian Patent Application 2456.13
(HHS reference E-117-2011/0-PE-30), Algerian Patent Application
130758 (HHS reference E-117-2011/0-DZ-31), Moroccan Patent
Application 36534 (HHS reference E-117-2011/0-MA-32), and Hong Kong
Patent Application 14108273.5 (HHS reference E-117-2011/0-HK-33);
U.S. Patent Application 61/241,620 (HHS Ref. E-269-2009/0-US-01),
PCT Application PCT/US2010/048504 (HHS reference E-269-2009/0-PCT-
02), Australian Patent 2010292069 (HHS reference E-269-2009/0-AU-
03), Canadian Patent Application 2773665 (HHS reference E-269-2009/
0-CA-04), Chinese Patent 201080049559.3 (HHS reference E-269-2009/0-
CN-05), European Patent 2475398 (HHS reference E-269-2009/0-EP-06),
as validated in France, Germany, Italy, Spain and the United
Kingdom, Indian Patent Application 3197/CHENP/2012 (HHS reference E-
269-2009/0-IN-07), Japanese Patent 5795765 (HHS reference E-269-
2009/0-JP-08), Russian Patent Application 2012114005 (HHS
[[Page 11927]]
reference E-269-2009/0-RU-09), and US Patent 8,936,792 (HHS
reference E-269-2009/0-US-10);
U.S. Patent Application 60/969,929 (HHS Ref. E-292-2007/0-US-01),
PCT Application PCT/US2008/075296 (HHS reference E-292-2007/0-PCT-
02), Australian Patent 2008296194 (HHS reference E-292-2007/0-AU-
03), Canadian Patent Application 2698357 (HHS reference E-292-2007/
0-CA-04), European Patent 2197903 (HHS reference E-292-2007/0-EP-05)
as validated in Austria, Belgium, Bulgaria, Switzerland, Cyprus,
Germany, Denmark, Estonia, Spain, Finland, France, the United
Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania,
Luxembourg, Latvia, Monaco, Malta, the Netherlands, Norway, Poland,
Portugal, Romania, Slovenia, Slovakia, and Turkey, US Patent
8,871,906 (HHS reference E-292-2007/0-US-06), European Patent
Application 12184319.7 (HHS reference E-292-2007/0-EP-07), and Hong
Kong Patent Application 13106628.2 (HHS reference E-292-2007/0-HK-
08);
U.S. Patent Application 60/703,798 (HHS Ref. E-262-2005/0-US-01),
PCT Application PCT/US2006/028986 (HHS reference E-262-2005/0-PCT-
02), Australian Patent 2006275865 (HHS reference E-262-2005/0-AU-
03), Canadian Patent 2616987 (HHS reference E-262-2005/0-CA-04),
European Patent 1910407 (HHS reference E-262-2005/0-EP-05) as
validated in Switzerland, Germany, Spain, France, the United
Kingdom, and Italy, US Patent 8,907,060 (HHS reference E-262-2005/0-
US-06), European Patent 2311854 (HHS reference E-262-2005/0-EP-07)
as validated in Switzerland, Germany, Spain, France, the United
Kingdom, and Italy, European Patent 2332970 (HHS reference E-262-
2005/0-EP-08) as validated in Germany, Spain, France, the United
Kingdom, and Italy, Australian Patent 2012216642 (HHS reference E-
262-2005/0-AU-15), Australian Patent 2014208269 (HHS reference E-
262-2005/0-AU-22), European Patent Application 15191388.6 (HHS
reference E-262-2005/0-EP-28), European Patent Application
15191391.0 (HHS reference E-262-2005/0-EP-29), European Patent
Application 15191395.1 (HHS reference E-262-2005/0-EP-30),
Australian Patent Application (HHS reference E-262-2005/0-AU-31),
and Canadian Patent Application (HHS reference E-262-2005/0-CA-32);
U.S. Patent Application 60/160,071 (HHS Ref. E-139-1999/0-US-01),
PCT Application PCT/US00/14829 (HHS reference E-139-1999/0-PCT-02),
Canadian Patent 2374398 (HHS reference E-139-1999/0-CA-03), European
Patent 1180123 (HHS reference E-139-1999/0-EP-04) as validated in
Belgium, Switzerland, Germany, Denmark, France, The United Kingdom,
Italy, The Netherlands, and Sweden, Japanese Patent 5683766 (HHS
reference E-139-1999/0-JP-05), Mexican Patent 270476 (HHS reference
E-139-1999/0-MX-06); and U.S. Patent 7,081,518 (HHS reference E-139-
1999/0-US-07);
U.S. Patent Application 60/067,175 (HHS Ref. E-021-1998/0-US-01),
PCT Application PCT/US98/25270 (HHS reference E-021-1998/0-PCT-02),
Australian Patent 760120 (HHS reference E-021-1998/0-AU-03),
Canadian Patent 2318576 (HHS reference E-021-1998/0-CA-04), European
Patent 1025230 (HHS reference E-021-1998/0-EP-05) as validated in
Switzerland, Germany, France, Italy, Spain and the United Kingdom,
Israeli Patent 135775 (HHS reference E-021-1998/0-IL-06), US Patent
6,809,184 (HHS reference E-021-1998/0-US-07), US Patent 7,368,110
(HHS reference E-021-1998/0-US-08), and US Patent 7,709,252 (HHS
reference E-021-1998/0-US-15),
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PCT Application PCT/US97/00224 (HHS Ref. E-002-1996/1-PCT-01), U.S.
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Patent 703769 (HHS reference E-002-1996/1-AU-03), Canadian Patent
2241604 (HHS reference E-002-1996/1-CA-04), European Patent 0871492
(HHS reference E-002-1996/1-EP-05) as validated in Switzerland,
Germany, France, Italy Spain and the United Kingdom, U.S. Patent
6,153,430 (HHS reference E-002-1996/1-US-14), and U.S. Patent
7,375,183 (HHS reference E-002-1996/1-US-15);
and all continuing applications and foreign counterparts.
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 use of anti-mesothelin targeted immunotoxins for the
treatment of mesothelin-expressing cancers, wherein the immunotoxins
have:
(1) A targeting domain containing the complementary determining
regions (CDRs) of the SS1 antibody; and
(2) A Pseudomonas exotoxin A (PE) toxin domain that lacks at least
one B cell or T cell epitope due to the alteration or deletion of one
or more amino acids.
For purposes of clarity, the immunotoxin may include additional
alterations to B cell and T cell epitopes for the reduction of
immunogenicity, a peptide linker sequence, and/or polyethylene glycol
molecule(s). The immunotoxins may also be combined with the use of
synthetic vaccine particle (SVP)-rapamycin.''
The present inventions to be licensed concern RITs which are
targeted to mesothelin-expressing cancer cells, and methods of using
the immunotoxins for the treatment of mesothelin-expressing cancers
(such as mesothelioma, ovarian cancer and pancreatic cancer). The
specific immunotoxin will have an antibody targeting domain that
contains the CDRs of the antibody identified as SS1, which was invented
at the NIH. The specific immunotoxin will also have a toxin domain
derived from PE that is resistant to lysosomal proteases due to the
deletion of a large portion of the exotoxin, and which lacks at least
one major B-cell epitope due to the alteration an amino acid.
Ultimately, the PE used in the immunotoxin may lack multiple B-cell
epitopes, as well as multiple T-cell epitopes, in an effort to minimize
immunogenicity.
Alterations to the toxin that reduce immunogenicity improve the
therapeutic value of the immunotoxin while maintaining its ability to
trigger cell death. Since mesothelin is preferentially expressed on
certain types of cancer cells, the immunotoxins selectively bind and
kill only those cancer cells, allowing healthy, essential cells to
remain unharmed. This may result in an effective therapeutic strategy
with fewer side effects, especially when combined with agents that can
suppress the formation of neutralizing antibodies.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. 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: February 21, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2017-03823 Filed 2-24-17; 8:45 am]
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