[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59797-59798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24982]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of a Start-up Exclusive Commercial License
Agreement: Development of MHC Class II Restricted T Cell Epitopes From
the Cancer Antigen, NY ESO-1, 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 404.7, that the National Institutes of Health, Department of
Health and Human Services, is contemplating the grant of an start-up
exclusive commercial license to Immunova Therapeutics, Inc., which is
located in Houston, Texas, to practice the inventions embodied in the
following patent applications and applications claiming priority to
these applications:
E-090-2000
1. U.S. Provisional Patent Application No. 61/179,004 filed January
28, 2000 entitled ``MHC Class II Restricted T Cell Epitopes from the
Cancer Antigen, NY ESO-1'' (HHS Ref No. E-090-2000/0-US-01);
2. U.S. Provisional Patent Application No. 60/237,107 filed
September 29, 2000 entitled ``HLA-DP Restricted CD4+ T Cell Epitopes
from the Cancer Antigen, NY ESO-1'' (HHS Ref No. E-227-2000/0-US-01
was combined with E-090-2000/0-US-01 at the PCT stage, creating the
E-090-2000/1 technology family and associated applications);
3. PCT Application No. PCT/US01/02765 filed January 26, 2001
entitled ``MHC Class II Restricted T Cell Epitopes from the Cancer
Antigen, NY ESO-1'' (HHS Ref No. E-090-2000/1-PCT-01);
4. Canadian Patent No. 2398743 issued June 23, 2015 entitled ``MHC
Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO-
1'' (HHS Ref No. E-090-2000/1-CA-02);
5. Australian Patent No. 785151 issued January 18, 2007 entitled
``MHC Class II Restricted T Cell Epitopes from the Cancer Antigen,
NY ESO-1'' (HHS Ref No. E-090-2000/1-AU-03);
6. Japanese Patent No. 5588363 issued August 1, 2014 entitled ``MHC
Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO-
1'' (HHS Ref No. E-090-2000/1-JP-12);
7. U.S. Patent No. 7,619,057 issued November 17, 2009 entitled ``MHC
Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO-
1'' (HHS Ref No. E-090-2000/1-US-06);
8. U.S. Patent No. 8,754,046 issued June 17, 2014 entitled ``MHC
Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO-
1'' (HHS Ref No. E-090-2000/1-US-07);
9. U.S. Patent Application No. 12/568,134 filed September 28, 2009
entitled ``MHC Class II Restricted T Cell Epitopes from the Cancer
Antigen, NY ESO-1'' (HHS Ref No. E-090-2000/1-US-013);
10. European Patent Application No. 10010354.8 filed January 26,
2001 entitled ``MHC Class II Restricted T Cell Epitopes from the
Cancer Antigen, NY ESO-1'' (HHS Ref No. E-090-2000/1-EP-10);
The patent rights in these inventions have been assigned to the
Government of the United States of America. The prospective start-up
exclusive commercial license territory may be worldwide and the field
of use may be limited to the use of the Licensed Patent Rights to
develop, manufacture, distribute, sell and use NY-ESO-1 based vaccines
and cell therapy products for the treatment of NY-ESO-1-positive
cancers.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
October 19, 2015 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
comments, and other materials relating to the contemplated exclusive
evaluation option license should be directed to: Sabarni K. Chatterjee,
Ph.D., M.B.A., 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) 276-5530; Facsimile: (240) 276-5504; Email:
[email protected].
SUPPLEMENTARY INFORMATION: NY-ESO-1 is a known tumor antigen which is
expressed on a broad range of tumor types, including melanoma, breast,
bladder, ovarian, prostate, head and neck cancers, neuroblastoma, and
small cell lung cancer. The above-referenced inventions embody the
identification of a number of novel immunogenic peptide epitopes, and
analogs thereof, which are derived from the NY-ESO-1 tumor antigen.
Specifically, this technology describes novel MHC Class II restricted
epitopes of NY-ESO-1 which are recognized by CD4+ T cells. It also
embodies the identification of two additional immunogenic peptide
epitopes of NY-ESO-1. The latter two epitopes are presented by HLA-DP4,
a prevalent MHC Class II allele present in 43-70% of Caucasians. The
inventors also determined that the DP allele is highly associated with
the NY-ESO-1 antibody production. In addition, one of these epitopes
has dual HLA A2 and DP4 specificity, thereby it has the potential to
generate both CD4+ and CD8+ tumor specific T cells. These epitopes may
be of great value as prophylactic and/or therapeutic cancer vaccines or
cell therapy products for use against a number of common cancers.
The prospective start-up exclusive commercial license is being
considered under the small business initiative launched on October 1,
2011 and will comply with the terms and conditions of 35 U.S.C. 209 and
37 CFR part 404.7. The prospective start-up exclusive commercial
license may be granted unless within fifteen (15) 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 part 404.7.
Any additional, properly filed, and 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
commercial 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.
[[Page 59798]]
Dated: September 28, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-24982 Filed 10-1-15; 8:45 am]
BILLING CODE 4140-01-P