[Federal Register Volume 78, Number 34 (Wednesday, February 20, 2013)]
[Pages 11895-11896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03799]



National Institutes of Health

Prospective Grant of Exclusive License: Development of MUC-1 
Tumor Associated Antigens as Cancer Vaccines for Bladder Cancer, Breast 
Cancer, Colorectal Cancer, Gastric Cancer, Kidney Cancer, Liver Cancer, 
Lung Cancer, Ovarian Cancer, Prostate Cancer and Pancreatic Cancer

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: U.S. provisional patent application no. 
61/582, 723 filed January 3, 2012 entitled ``Native and Agonist CTL 
Epitopes of the MUC-1 Tumor Antigen'' [HHS Ref. No. E-001-2012/0-US-
01] as well as all international applications, continuation 
applications and divisional applications.

    The patent rights in these inventions have been assigned to the 
government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use will be limited to the use of Licensed Patent Rights 
for development of Pox-virus based vaccines for bladder cancer, breast 
cancer, colorectal cancer, gastric cancer, kidney cancer, liver cancer, 
lung cancer, ovarian cancer, prostate cancer and pancreatic cancer.''

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
March 22, 2013 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Sabarni K. Chatterjee, Ph.D., M.B.A. Licensing and 
Patenting Manager, 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; Email: [email protected].

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 ``co-
stimulatory'' signal is required for cytokine production, 
proliferation, and other aspects of T-cell activation.
    Dr. Jeffrey Schlom et al. at NCI have identified 7 new agonist 
epitopes of the MUC-1 tumor associated antigen. Compared to their 
native epitope counterparts, peptides reflecting these agonist epitopes 
have enhanced ability to generate cytotoxic T-lymphocytes (CTL), which 
in turn have a greater ability to kill MUC-1 expressing human tumor 
cells. The agonist epitopes span both the VNTR region of MUC-1 and the 
C-terminus region. The epitopes encompass two major MHC alleles 
reflecting the majority of the population.
    Along with the method of use, the technology encompasses the use of 
these agonist epitopes in peptide- and protein-based vaccines, with 
dendritic cells or other antigen presenting cells, or encoding 
sequences in DNA, viral, bacterial, yeast, or other types of vectors, 
or to stimulate T-cells in vitro for adoptive immunotherapy protocols.
    The MUC-1 tumor associated antigen has been shown to be 
overexpressed and/or underglycosylated in a wide range of human 
cancers. The C-terminus region of MUC-1 (MUC-1C) has been shown to be 
an oncogene and has been associated with a more aggressive phenotype in 
several different cancers.
    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 Part 
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 Part 404.7.

[[Page 11896]]

    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: February 13, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-03799 Filed 2-19-13; 8:45 am]