Prospective Grant of Exclusive License: Development of PANVAC and Tumor Associated Antigens as Cancer Vaccines, 16490-16491 [2010-7341]
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16490
Federal Register / Vol. 75, No. 62 / Thursday, April 1, 2010 / Notices
Suite 2C212, Bethesda, MD 20892,
(Telephone Conference Call)
Contact Person: Bita Nakhai, PhD,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, Gateway
Bldg., 2C212, 7201 Wisconsin Avenue,
Bethesda, MD 20814, 301–402–7701,
nakhaib@nia.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Adiposity,
Aging, and Stem Cells.
Date: June 23, 2010.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite 2C212, Bethesda, MD 20892,
(Telephone Conference Call)
Contact Person: Rebecca J. Ferrell, PhD,
Scientific Review Officer, National Institute
on Aging, Gateway Building Rm. 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892,
301–402–7703, ferrellrj@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: March 29, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–7344 Filed 3–31–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of PANVAC and
Tumor Associated Antigens as Cancer
Vaccines
mstockstill on DSKH9S0YB1PROD with NOTICES
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
patent license to practice the inventions
embodied in the following U.S. Patents
and Patent Applications to Bavarian
Nordic Immunotherapeutics (‘‘BNIT’’)
located in Mountain View, CA, USA.
Intellectual Property:
1. U.S. Patent No. 6,756,038 issued
June 29, 2004 as well as issued and
pending foreign counterparts [HHS Ref.
No. E–099–1996/0–US–07];
2. U.S. Patent Application No. 10/
725,373 (recently allowed) filed
December 3, 2003 as well as
continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
099–1996/0–US–08];
VerDate Nov<24>2008
16:51 Mar 31, 2010
Jkt 220001
3. U.S. Patent No. 6,001,349 issued 14
Dec. 1999 as well as issued and pending
foreign counterparts [HHS Ref. No. E–
200–1990/3–US–01];
4. U.S. Patent Application No. 10/
579,025 filed May 11, 2006 as well as
all continuation and divisional
applications, and issued and pending
foreign counterparts [E–087–2005/0–
US–03];
5. U.S. Patent Application No. 10/
579,007 filed May 11, 2006 as well as
all continuation and divisional
applications, and issued and pending
foreign counterparts [E–088–2005/0–
US–03];
6. U.S. Patent No. 7,118,738 issued
October 10, 2006 as well as all
continuations and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
154–1998/0–US–07];
7. U.S. Patent Application Nos. 08/
686,280 filed July 25, 1996 as well as all
issued and pending foreign counterparts
[HHS Ref. No. E–259–1994/3–US–01];
8. U.S. Patent No. 7,410,644 issued
August 12, 2008 as well as all
continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
259–1994/3–US–08];
9. U.S. Patent Nos. 6,893,869,
6,548,068 and 6,045,802 issued May 17,
2005, April 15, 2003 and April 4, 2000
respectively, as well as issued and
pending foreign counterparts [HHS Ref.
Nos. E–260–1994/1–US–03, US–02, US–
01]; U.S. Patent No. 7,368,116 issued
May 6, 2008 and U.S. Patent
Application No. 12/112,819, as well as
all continuation and divisional
applications [HHS Ref. Nos. E–260–
1994/1–US–04 and US–05];
10. Europe Patent Application No.
00102998.2 filed October 2, 1995,
Europe Patent No. 0784483 issued
November 29, 2001, Europe Patent
Application No. 09013495.8 filed
October 26, 2009, as well as all
continuation, and divisional
applications [HHS Ref. Nos. E–260–
1994/2–EP–15, EP–16 and EP–27]; Japan
Patent Application No. 512100/96 filed
October 2, 1995; Japan Patent No.
4078319 issued February 8, 2008 [HHS
Ref. No. E–260–1994/2–JP–25]; and
Japan Patent No. 4160612 issued July
25, 2008, as well as all continuation and
divisional applications; [HHS Ref. No.
E–260–1994/2–JP–21, JP–25 and JP–26];
Australia Patent No. 688606 issued July
2, 1998 [E–260–1994/2–AU–11]; Canada
Patent No. 2201587 issued June 25, 2002
[E–260–1994/2–CA–12];
11. Canada Patent Application No.
2,412,050 filed June 15, 2001 [HHS Ref.
No. E–187–2000/0–CA–05]; Australia
Patent No. 2001268452 issued
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
November 30, 2006 [HHS Ref. No. E–
187–2000/0–AU–06]; Japan Patent
Application No. 2002–510097 filed June
15, 2001 [HHS Ref. No. E–187–2000/0–
JP–07]; Hong Kong Patent Application
No. 03105975.5 filed June 15, 2001
[HHS Ref. No. E–187–2000/0–HK–08];
as well as all continuation and
divisional applications;
12. U.S. Patent Application No. 12/
280,534 filed February 21, 2007, [HHS
Ref. No. E–104–2006/0–US–06];
Australia Patent Application No.
2007221255 filed February 21, 2007
[HHS Ref. No. E–104–2006/0–AU–03];
Europe Patent Application No.
07751371.1 filed February 21, 2007,
[HHS Ref. No. E–104–2006/0–US–06];
filed February 21, 2007, [HHS Ref. No.
E–104–2006/0–EP–05]; Canada Patent
Application No. 2642994 filed February
21, 2007 [HHS Ref. No. E–104–2006/0–
CA–04]; as well as all continuation and
divisional and applications;
13. U.S. Patent Application No. 12/
528,796 filed August 26, 2009 [HHS Ref.
No. E–074–2007/0–US–07]; Australia
Patent Application No. 2008221383
filed February 27, 2008 [HHS Ref. No.
E–074–2007/0–AU–03]; Europe Patent
Application No. 08743578.0 filed
February 27, 2008 [HHS Ref. No. E–074–
2007/0–EP–05]; Canada Patent
Application No. 2,678,404 filed
February 27, 2008 [HHS Ref. No. E–074–
2007/0–CA–04]; Japan Patent
Application No. not yet assigned filed
February 27, 2008 [HHS Ref. No. E–074–
2007/0–JP–06] as well as all
continuation, divisional and pending
foreign counterpart applications;
Group II—Nonexclusive Licensed
Patent Rights:
1. U.S. Patent No. 6,969,609 issued
November 29, 2005; U.S. Patent No.
7,211,432 issued May 1, 2007; U.S.
Patent Application No. 11/723,666 filed
March 21, 2007; as well as all
continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
256–1998/0, 1];
2. U.S. Patent Application Nos. 60/
448,591 and 10/543,944 filed February
20, 2003 and February 20, 2004
respectively, as well as all continuation
and divisional applications, and issued
and pending foreign counterparts [HHS
Ref. No. E–028–2007/0];
3. U.S. Patent No. 6,699,475 issued
March 2, 2004, as well as all
continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
134–2007/0];
4. U.S. Patent No. 5,093,258 issued
March 3, 1992, as well as all
continuation and divisional
applications, and issued and pending
E:\FR\FM\01APN1.SGM
01APN1
mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 75, No. 62 / Thursday, April 1, 2010 / Notices
foreign counterparts [HHS Ref. No. E–
135–2007/0];
5. U.S. Patent Application No. 07/
205,189 filed June 10, 1988, as well as
all continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref No. E–
136–2007];
6. U.S. Patent Application No. 60/
625,321 filed November 5, 2004, as well
as all continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
138–2007]; and
7. U.S. Patent Application No. 07/
340,052 filed April 18, 1989, as well as
all continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
147–2007].
The patent rights in these inventions
have been assigned to the United States
of America.
The prospective exclusive license
territory may be worldwide and the
field of use may be use of Licensed
Patent Rights for development of
therapeutics for human cancers. The
field of use will specifically exclude
prostate cancer, melanoma and
colorectal cancer. For the avoidance of
doubt, delivery formulations shall
specifically exclude canary poxvirus
vectors, NYVAC, non-viral eukaryotic
expression vectors and recombinant
yeast vectors in all geographic
territories.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before May 3,
2010 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: Sabarni K. Chatterjee,
Ph.D. Licensing and Patenting
Associate, Cancer Branch, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Telephone: (301) 435–5587; Facsimile:
(301) 435–4013; E-mail:
chatterjeesa@od.nih.gov.
SUPPLEMENTARY INFORMATION: Cancer
immunotherapy is a recent approach
where tumor associated antigens
(TAAs), which are primarily expressed
in human tumor cells, and not
expressed or minimally expressed in
normal tissues, are employed to
generate a tumor-specific immune
response. Specifically, these antigens
serve as targets for the host immune
system and elicit responses that results
in tumor destruction. The initiation of
an effective T-cell immune response to
VerDate Nov<24>2008
16:51 Mar 31, 2010
Jkt 220001
antigens requires two signals. The first
one is antigen-specific via the peptide/
major histocompatibility complex and
the second or ‘‘costimulatory’’ signal is
required for cytokine production,
proliferation, and other aspects of T-cell
activation.
The patents and patent applications
describe a vaccine technology, TRICOM,
in conjunction with tumor associated
antigens (TAAs). The TRICOM
technology employs avirulent
poxviruses to present a combination of
costimulatory signaling molecules with
tumor-associated antigens (TAAs) to
activate T-cells and break the immune
systems tolerance towards cancer cells.
This is achieved using recombinant
poxvirus DNA vectors that encode both
T-cell costimulatory molecules and
TAAs. The combination of the three (3)
costimulatory molecules B7.1, ICAM–1
and LFA–3, hence the name TRICOM,
has been shown to have more than the
additive effect of each costimulatory
molecule when used individually to
optimally activate both CD4+ and CD8+
T cells. When a TRICOM based vaccine
expressing TAAs is administered it
greatly enhances the immune response
against the malignant cells expressing
those TAAs. By changing the TAAs
used for immunization with TRICOM
vaccines, immune responses can be
generated to diverse types of cancers.
The versatility of the vector-based
TRICOM based vaccine is that it allows,
including several TAAs, to help
maximize the effectiveness. Transgenes
reflecting alterations of TAAs can also
be inserted into TRICOM based vaccines
to further enhance immunogenicity. The
addition of the two well-known TAAs,
carcinoembryonic antigen (CEA) and
MUC–1 to the TRICOM vector results in
the PANVAC vaccine, which is used in
a prime and boost vaccine strategy. It is
well established that the overexpression
of these two (2) TAAs are associated
with the presence of a variety of
carcinomas; therefore PANVAC can
potentially be effective against a range
of tumor types.
Additionally, new TAAs are being
continually identified. One such
example is the antigen Brachyury.
Although Brachyury has been well
known for its role in developmental cell
biology, it has recently been implicated
in tumor cell invasion and metastasis.
Pre-clinical data indicates that
Brachyury is aberrantly expressed on
tumors of the lung, intestine, stomach,
kidney, bladder, uterus, ovary, and
testis, and in chronic lymphocytic
leukemia. When used in combination
with costimulatory molecules, it can
effectively activate T-cells to kill tumors
cells that originated from above
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
16491
mentioned tumors. Therefore, as one
example, Brachyury combined with
TRICOM also has potential as a cancer
immunotherapy for the treatment of
several tumors.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless
within thirty (30) days from the date of
this published notice, 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 404.7.
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 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: March 26, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–7341 Filed 3–31–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2010–0026]
Science and Technology Directorate;
Submission for Review; Information
Collection Request for the Department
of Homeland Security Science and
Technology Directorate First
Responders Community of Practice
AGENCY: Science and Technology
Directorate, DHS.
ACTION: 30-day Notice and request for
comment.
SUMMARY: The Department of Homeland
Security (DHS) invites the general
public to comment on a new data
collection form for the Science and
Technology Directorate (S&T) First
Responders Community of Practice
(FRCoP): User Registration Page (DHS
Form 10059 (9/09)). The FRCoP webbased tool will be collecting profile
information from first responders and
select authorized non-first responder
users to facilitate networking and
formation of online communities. All
users will be required to authenticate
prior to entering the site. In addition,
the tool will provide members the
E:\FR\FM\01APN1.SGM
01APN1
]]>Agencies
[Federal Register Volume 75, Number 62 (Thursday, April 1, 2010)]
[Notices]
[Pages 16490-16491]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7341]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Development of PANVAC and
Tumor Associated Antigens as Cancer Vaccines
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR part 404.7(a)(1)(i), that the National Institutes of Health,
Department of Health and Human Services, is contemplating the grant of
an exclusive patent license to practice the inventions embodied in the
following U.S. Patents and Patent Applications to Bavarian Nordic
Immunotherapeutics (``BNIT'') located in Mountain View, CA, USA.
Intellectual Property:
1. U.S. Patent No. 6,756,038 issued June 29, 2004 as well as issued
and pending foreign counterparts [HHS Ref. No. E-099-1996/0-US-07];
2. U.S. Patent Application No. 10/725,373 (recently allowed) filed
December 3, 2003 as well as continuation and divisional applications,
and issued and pending foreign counterparts [HHS Ref. No. E-099-1996/0-
US-08];
3. U.S. Patent No. 6,001,349 issued 14 Dec. 1999 as well as issued
and pending foreign counterparts [HHS Ref. No. E-200-1990/3-US-01];
4. U.S. Patent Application No. 10/579,025 filed May 11, 2006 as
well as all continuation and divisional applications, and issued and
pending foreign counterparts [E-087-2005/0-US-03];
5. U.S. Patent Application No. 10/579,007 filed May 11, 2006 as
well as all continuation and divisional applications, and issued and
pending foreign counterparts [E-088-2005/0-US-03];
6. U.S. Patent No. 7,118,738 issued October 10, 2006 as well as all
continuations and divisional applications, and issued and pending
foreign counterparts [HHS Ref. No. E-154-1998/0-US-07];
7. U.S. Patent Application Nos. 08/686,280 filed July 25, 1996 as
well as all issued and pending foreign counterparts [HHS Ref. No. E-
259-1994/3-US-01];
8. U.S. Patent No. 7,410,644 issued August 12, 2008 as well as all
continuation and divisional applications, and issued and pending
foreign counterparts [HHS Ref. No. E-259-1994/3-US-08];
9. U.S. Patent Nos. 6,893,869, 6,548,068 and 6,045,802 issued May
17, 2005, April 15, 2003 and April 4, 2000 respectively, as well as
issued and pending foreign counterparts [HHS Ref. Nos. E-260-1994/1-US-
03, US-02, US-01]; U.S. Patent No. 7,368,116 issued May 6, 2008 and
U.S. Patent Application No. 12/112,819, as well as all continuation and
divisional applications [HHS Ref. Nos. E-260-1994/1-US-04 and US-05];
10. Europe Patent Application No. 00102998.2 filed October 2, 1995,
Europe Patent No. 0784483 issued November 29, 2001, Europe Patent
Application No. 09013495.8 filed October 26, 2009, as well as all
continuation, and divisional applications [HHS Ref. Nos. E-260-1994/2-
EP-15, EP-16 and EP-27]; Japan Patent Application No. 512100/96 filed
October 2, 1995; Japan Patent No. 4078319 issued February 8, 2008 [HHS
Ref. No. E-260-1994/2-JP-25]; and Japan Patent No. 4160612 issued July
25, 2008, as well as all continuation and divisional applications; [HHS
Ref. No. E-260-1994/2-JP-21, JP-25 and JP-26]; Australia Patent No.
688606 issued July 2, 1998 [E-260-1994/2-AU-11]; Canada Patent No.
2201587 issued June 25, 2002 [E-260-1994/2-CA-12];
11. Canada Patent Application No. 2,412,050 filed June 15, 2001
[HHS Ref. No. E-187-2000/0-CA-05]; Australia Patent No. 2001268452
issued November 30, 2006 [HHS Ref. No. E-187-2000/0-AU-06]; Japan
Patent Application No. 2002-510097 filed June 15, 2001 [HHS Ref. No. E-
187-2000/0-JP-07]; Hong Kong Patent Application No. 03105975.5 filed
June 15, 2001 [HHS Ref. No. E-187-2000/0-HK-08]; as well as all
continuation and divisional applications;
12. U.S. Patent Application No. 12/280,534 filed February 21, 2007,
[HHS Ref. No. E-104-2006/0-US-06]; Australia Patent Application No.
2007221255 filed February 21, 2007 [HHS Ref. No. E-104-2006/0-AU-03];
Europe Patent Application No. 07751371.1 filed February 21, 2007, [HHS
Ref. No. E-104-2006/0-US-06]; filed February 21, 2007, [HHS Ref. No. E-
104-2006/0-EP-05]; Canada Patent Application No. 2642994 filed February
21, 2007 [HHS Ref. No. E-104-2006/0-CA-04]; as well as all continuation
and divisional and applications;
13. U.S. Patent Application No. 12/528,796 filed August 26, 2009
[HHS Ref. No. E-074-2007/0-US-07]; Australia Patent Application No.
2008221383 filed February 27, 2008 [HHS Ref. No. E-074-2007/0-AU-03];
Europe Patent Application No. 08743578.0 filed February 27, 2008 [HHS
Ref. No. E-074-2007/0-EP-05]; Canada Patent Application No. 2,678,404
filed February 27, 2008 [HHS Ref. No. E-074-2007/0-CA-04]; Japan Patent
Application No. not yet assigned filed February 27, 2008 [HHS Ref. No.
E-074-2007/0-JP-06] as well as all continuation, divisional and pending
foreign counterpart applications;
Group II--Nonexclusive Licensed Patent Rights:
1. U.S. Patent No. 6,969,609 issued November 29, 2005; U.S. Patent
No. 7,211,432 issued May 1, 2007; U.S. Patent Application No. 11/
723,666 filed March 21, 2007; as well as all continuation and
divisional applications, and issued and pending foreign counterparts
[HHS Ref. No. E-256-1998/0, 1];
2. U.S. Patent Application Nos. 60/448,591 and 10/543,944 filed
February 20, 2003 and February 20, 2004 respectively, as well as all
continuation and divisional applications, and issued and pending
foreign counterparts [HHS Ref. No. E-028-2007/0];
3. U.S. Patent No. 6,699,475 issued March 2, 2004, as well as all
continuation and divisional applications, and issued and pending
foreign counterparts [HHS Ref. No. E-134-2007/0];
4. U.S. Patent No. 5,093,258 issued March 3, 1992, as well as all
continuation and divisional applications, and issued and pending
[[Page 16491]]
foreign counterparts [HHS Ref. No. E-135-2007/0];
5. U.S. Patent Application No. 07/205,189 filed June 10, 1988, as
well as all continuation and divisional applications, and issued and
pending foreign counterparts [HHS Ref No. E-136-2007];
6. U.S. Patent Application No. 60/625,321 filed November 5, 2004,
as well as all continuation and divisional applications, and issued and
pending foreign counterparts [HHS Ref. No. E-138-2007]; and
7. U.S. Patent Application No. 07/340,052 filed April 18, 1989, as
well as all continuation and divisional applications, and issued and
pending foreign counterparts [HHS Ref. No. E-147-2007].
The patent rights in these inventions have been assigned to the
United States of America.
The prospective exclusive license territory may be worldwide and
the field of use may be use of Licensed Patent Rights for development
of therapeutics for human cancers. The field of use will specifically
exclude prostate cancer, melanoma and colorectal cancer. For the
avoidance of doubt, delivery formulations shall specifically exclude
canary poxvirus vectors, NYVAC, non-viral eukaryotic expression vectors
and recombinant yeast vectors in all geographic territories.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before May
3, 2010 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: Sabarni K. Chatterjee, Ph.D. Licensing
and Patenting Associate, Cancer Branch, Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, MD 20852-3804; Telephone: (301) 435-5587; Facsimile: (301)
435-4013; E-mail: chatterjeesa@od.nih.gov.
SUPPLEMENTARY INFORMATION: Cancer immunotherapy is a recent approach
where tumor associated antigens (TAAs), which are primarily expressed
in human tumor cells, and not expressed or minimally expressed in
normal tissues, are employed to generate a tumor-specific immune
response. Specifically, these antigens serve as targets for the host
immune system and elicit responses that results in tumor destruction.
The initiation of an effective T-cell immune response to antigens
requires two signals. The first one is antigen-specific via the
peptide/major histocompatibility complex and the second or
``costimulatory'' signal is required for cytokine production,
proliferation, and other aspects of T-cell activation.
The patents and patent applications describe a vaccine technology,
TRICOM, in conjunction with tumor associated antigens (TAAs). The
TRICOM technology employs avirulent poxviruses to present a combination
of costimulatory signaling molecules with tumor-associated antigens
(TAAs) to activate T-cells and break the immune systems tolerance
towards cancer cells. This is achieved using recombinant poxvirus DNA
vectors that encode both T-cell costimulatory molecules and TAAs. The
combination of the three (3) costimulatory molecules B7.1, ICAM-1 and
LFA-3, hence the name TRICOM, has been shown to have more than the
additive effect of each costimulatory molecule when used individually
to optimally activate both CD4+ and CD8+ T cells. When a TRICOM based
vaccine expressing TAAs is administered it greatly enhances the immune
response against the malignant cells expressing those TAAs. By changing
the TAAs used for immunization with TRICOM vaccines, immune responses
can be generated to diverse types of cancers. The versatility of the
vector-based TRICOM based vaccine is that it allows, including several
TAAs, to help maximize the effectiveness. Transgenes reflecting
alterations of TAAs can also be inserted into TRICOM based vaccines to
further enhance immunogenicity. The addition of the two well-known
TAAs, carcinoembryonic antigen (CEA) and MUC-1 to the TRICOM vector
results in the PANVAC vaccine, which is used in a prime and boost
vaccine strategy. It is well established that the overexpression of
these two (2) TAAs are associated with the presence of a variety of
carcinomas; therefore PANVAC can potentially be effective against a
range of tumor types.
Additionally, new TAAs are being continually identified. One such
example is the antigen Brachyury. Although Brachyury has been well
known for its role in developmental cell biology, it has recently been
implicated in tumor cell invasion and metastasis. Pre-clinical data
indicates that Brachyury is aberrantly expressed on tumors of the lung,
intestine, stomach, kidney, bladder, uterus, ovary, and testis, and in
chronic lymphocytic leukemia. When used in combination with
costimulatory molecules, it can effectively activate T-cells to kill
tumors cells that originated from above mentioned tumors. Therefore, as
one example, Brachyury combined with TRICOM also has potential as a
cancer immunotherapy for the treatment of several tumors.
The prospective exclusive license will be royalty bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
The prospective exclusive license may be granted unless within thirty
(30) days from the date of this published notice, 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 404.7.
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 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: March 26, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-7341 Filed 3-31-10; 8:45 am]
BILLING CODE 4140-01-P
