Notice: Government-Owned Inventions; Licensing and Collaborative Research 
Opportunity: Chemotoxins for Targeted Treatment of Diseased Cells

Federal Register: Volume 76, Number 236 (Thursday, December 8, 2011)
                  Pages 76743-76744

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
the U.S. patents and patent applications listed below may be obtained 
by contacting Patrick McCue, Ph.D. at the Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852; telephone: (301) 496-7057; e-mail: 
McCuepat@mail.nih.gov. A signed Confidential Disclosure Agreement will 
be required to receive copies of the patent applications.
    Inquiries related to Collaborative Research Opportunities may be 
directed to Nikki Guyton, Ph.D. at the Technology Transfer Center, 
National Cancer Institute, 6120 Executive Boulevard, Suite 450, 
Rockville, MD 20852; telephone: (301) 435-3101; email: 
darackn@mail.nih.gov.

SUPPLEMENTARY INFORMATION:

Technology

    Researchers at the National Institute on Aging (NIA) have developed 
a straightforward method to elicit immune responses to specific cancers 
and AIDS by using a chemoattractant-based antigen delivery strategy. 
The strategy uses formulations composed of chemokines fused to toxic 
moieties (aka ``chemotoxins'') to preferentially and specifically 
eliminate chemokine receptor-expressing cells. The method uses the 
natural ability of the chemokines to stimulate measurable and improved 
humoral and immune responses.
     Chemokines can be of viral or microbial (B-Defensin) 
origin.
     This method can also be used to cause inflammation to 
specifically target immune cells to increase immunogenicity for 
malignant tumors using SPANX-B and Laminin tumor antigens.

Potential Commercial Applications

     A potential immunotherapeutic antigen for the treatment of 
several malignancies including lymphoma, breast, lung, and ovarian.
     Use as a monoclonal antibody.
     Antigens, such as SPANX-B and Laminin, can also be used as 
prognostic and diagnostic agents for the monitoring of disease.

Competitive Advantages

     In contrast to recombinant proteins, these small peptides 
can be more easily manufactured.
     They help to facilitate the activation of cells in a more 
specific and therapeutically effective way.
     Active immune system will do a better job attacking cancer 
cells.
     Simple and less invasive.

Collaborative Research Opportunity

    The National Institute on Aging (NIA) is seeking parties interested 
in collaborative research to further evaluate or commercialize 
effective vaccines that target bacterial, viral, or tumor antigens. Any 
or all of the inventions in this announcement are available for co-
development and collaboration.

Intellectual Property and Developmental Status

     Viral Chemokine Antigen Fusion Proteins (E-194-2000).
    Patent Status: US Patent No. 6,562,347 issued 13 May 2003.

[[Page 76744]]

    Developmental Status: Proof of concept and pre-clinical development 
ongoing.
     Anti-Tumor Immunity Elicited by Defensin Tumor Antigen 
Fusion Proteins (E-196-2000).
    Patent Status: US Patent No. 7,754,676 issued 13 Jul 2010; US 
Patent No. 7,915,040 issued 29 Mar 2011; US Patent Application No. 13/
019,160 filed 01 Feb 2011.
    Developmental Status: Clinical Trials Pending.
     Vaccine for the Treatment of Malignancies Expressing 
Immature Laminin Receptor Protein (OFA-iLRP) (E-271-2006).
    Patent Status: US Patent Application No. 11/899,165 filed 03 Sep 
2007; US Provisional Application No. 60/841,927 filed 01 Sep 2006.
    Developmental Status: Pre-clinical with ongoing clinical tests in 
patients with NSCLC.
     Tumor Associated Antigen SPANX-B for Cancer Immunotherapy 
(E-089-2009).
    Patent Status: US Provisional Application No. 61/156,435 filed 27 
Feb 2009.
    Developmental Status: Ongoing In vitro pre-clinical studies on 
human tumor cells.

References

1. A Biragyn et al. Genetic fusion of chemokines to a self tumor 
antigen induces protective, T-cell dependent antitumor immunity. Nat 
Biotechnol. 1999 Mar;17(3):253-258. [PMID 10096292]
2. A Biragyn et al. Mediators of innate immunity that target 
immature, but not mature, dendritic cells induce antitumor immunity 
when genetically fused with nonimmunogenic tumor antigens. J 
Immunol. 2001 Dec 1;167(11):6644-6653. [PMID 11714836]
3. G Almanzar et al. Sperm-derived SPANX-B is a clinically relevant 
tumor antigen that is expressed in human tumors and readily 
recognized by human CD4+ and CD8+ T cells. Clin Cancer Res. 2009 Mar 
15;15(6):1954-1963. [PMID 19276289]

    For information on the Immunotherapeutics Unit, Laboratory of 
Molecular Biology and Immunology of the National Institute on Aging 
(NIA), please visit: http://www.grc.nia.nih.gov/branches/lmbi/cis_itu.htm.

    Dated: December 2, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-31554 Filed 12-7-11; 8:45 am]
BILLING CODE 4140-01-P