[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7215-7217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02490]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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. 209 and 37 CFR Part 404 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. patent applications listed below may be obtained by writing to 
the indicated licensing contact at the Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to 
receive copies of the patent applications.

Multivalent Immunogenic Peptides (Vaccines) for the Treatment of 
Prostate and Breast Cancer

    Description of Technology: The development of more targeted means 
of treating cancer is vital. One option for a targeted treatment is the 
creation of a vaccine that induces an immune response only against 
cancer cells. In this sense, vaccination involves the introduction of a 
peptide into a patient that causes the formation of antibodies or T 
cells that recognize the peptide. If the peptide is from a protein 
found selectively on/in cancer cells, those antibodies or T cells can 
trigger the death of those cancer cells without harming non-cancer 
cells. This can result in fewer side effects for the patient.
    TARP (T cell receptor gamma alternate reading frame protein) is a 
protein that is selectively expressed on the cells of about 95% of 
prostate cancers and about 50% of breast cancers. This invention 
concerns the identification of a combination of immunogenic peptides 
within TARP and their use to create an anti-cancer immune response in 
patients. By introducing these seven peptides into a patient, an immune 
response against these cancer cells can be initiated by the peptides, 
resulting in treatment of the cancer.
    Potential Commercial Applications:

 Peptides can be used as vaccines to induce an immune response 
against cancer
 Treatment of any cancer associated with increased or 
preferential expression of TARP
 Specific diseases include breast cancer and prostate cancer

    Competitive Advantages:

 Targeted therapy decreases non-specific killing of healthy, 
essential cells, resulting in fewer non-specific side-effects and 
healthier patients
 Use of multiple peptides permits production of a more thorough 
complement of T cells against the antigen

    Development Stage:

 In vitro data available
 In vivo data available (animal)
 In vivo data available (human)
    Inventors: Jay A. Berzofsky, et al. (NCI)
    Publications:

1. Epel M, et al. Targeting TARP, a novel breast and prostate tumor-
associated antigen, with T cell receptor-like human recombinant 
antibodies. Eur J Immunol. 2008 Jun;38(6):1706-20. [PMID

[[Page 7216]]

18446790]
2. Oh S, et al. Human CTLs to wild-type and enhanced epitopes of a 
novel prostate and breast tumor-associated protein, TARP, lyse human 
breast cancer cells. Cancer Res. 2004 Apr 1;64(7):2610-8. [PMID 
15059918]

    Intellectual Property: HHS Reference No. E-047-2014/0--US 
Provisional Patent Application No. 61/915,948 filed 13 Dec 2013
    Related Technologies: HHS Reference No. E-116-2003/0--
 U.S. Patent No. 8,043,623 issued 02 Jun 2009
 U.S. Patent No. 7,541,035 issued 25 Oct 2011
    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; 
[email protected]
    Collaborative Research Opportunity: The Vaccine Branch, CCR, NCI, 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate or commercialize 
cancer vaccines to induce T cell immunity against TARP to treat 
prostate and/or breast cancer. For collaboration opportunities, please 
contact John D. Hewes, Ph.D. at [email protected].

Novel Immunocytokine for the Treatment of Cancer

    Description of Technology: Mesothelin is a protein that is 
aberrantly expressed by several cancers, most notably malignant 
mesothelioma. Immunoconjugates that target mesothelin are currently 
being evaluated in clinical trials. Unfortunately, these 
immunoconjugates often use bacterial toxins as the payload, leading to 
the formation of neutralizing antibodies by patients and resulting in a 
reduction in therapeutic effectiveness over multiple administrations.
    Interleukin-12 (IL12) is a protein that has potent anti-tumor, 
anti-angiogenic, and anti-metastatic properties. Although initially 
considered an attractive candidate as a cancer therapeutic, systemic 
administration of IL12 is toxic.
    Inventors at the NIH have created an immunoconjugate using an anti-
mesothelin antibody (SS1) as the targeting moiety and IL12 as the 
payload molecule. This allows the localized concentration of IL12 at 
cancer cells, reducing the toxic effects seen with systemic IL12 
administration. Furthermore, using IL12 instead of a bacterial toxin 
helps to reduce the formation of neutralizing antibodies. The IL12-SS1 
immunoconjugate is able to inhibit the growth human malignant 
mesothelioma in mouse xenograft models, suggesting it has significant 
potential as a cancer therapeutic.
    Potential Commercial Applications:

 Selective killing of cells that express mesothelin, such as 
those seen with particular cancers.
 Specific cancers include malignant mesothelioma, pancreatic 
cancer and ovarian cancer.

    Competitive Advantages:

 Targeted therapy decreases non-specific killing of healthy, 
essential cells, resulting in fewer non-specific side-effects and 
healthier patients.
 Use of human IL12 as the payload may reduce formation of 
neutralizing antibodies against the molecule, increasing therapeutic 
effectiveness.
    Development Stage:
 In vitro data available
 In vivo data available (animal)

    Inventors: Mitchell Ho, et al. (NCI)
    Publication:

Kim H, et al. Novel immunocytokine IL12-SS1(Fv) inhibits 
mesothelioma tumor growth in nude mice. PLoS One. 2013 Nov 
15;8(11):e81919. [PMID 24260587]

    Intellectual Property: HHS Reference No. E-118-2013/0--US 
Provisional Patent Application 61/820,523 filed 07 May 2013
    Related Technology: HHS Reference No. E-139-1999/0--U.S. Patent 
7,081,518 issued 25 July 2006
    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; 
[email protected]
    Collaborative Research Opportunity: The NCI Laboratory of Molecular 
Biology is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate or 
commercialize the immunocytokine-based therapy targeting mesothelin-
expressing tumors. For collaboration opportunities, please contact John 
Hewes, Ph.D. at [email protected].

Improved Personalized Cancer Immunotherapy: Rapid Selection of Tumor 
Reactive T Cells Based on Expression of Specific Cell Surface Markers 
From Peripheral Blood

    Description of Technology: Scientists at NIH have identified a 
process to select highly tumor-reactive T cells from a patient's 
peripheral blood sample based on the expression of two specific T cell 
surface markers: programmed cell death protein 1 (PD-1; CD279) and/or T 
cell Ig- and mucin-domain-containing molecule-3 (TIM-3). After this 
enriched population of tumor-reactive T cells is selected and expanded 
to large quantities, it gets re-infused into the patient via an 
adoptive cell transfer (ACT) regimen. The key finding for this process 
is that the most tumor-reactive T cells found in a bulk population of 
cells obtained from a patient's peripheral blood sample reliably 
exhibit high expression of at least one of these markers. The 
enrichment of tumor-reactive cells from a patient's peripheral blood 
based on these markers provides and simple alternative to the current 
strategies based on isolation tumor-reactive cells from the tumor, as 
it reduces the cost and complications of tumor resection, as well as 
provides a T cell product for patients without resectable lesions.
    This new method for selecting tumor-reactive T cells from 
peripheral blood samples should help ACT immunotherapy become more GMP 
compliant and allow greater standardized of the production process to 
enable more widespread utilization of this personalized cancer 
treatment approach outside of NIH.

Potential Commercial Applications:
 Personalized ACT immunotherapy to treat cancers using T cells 
obtained from a peripheral blood.
 Possible integration into a standard procedure for obtaining 
tumor-reactive T cells from a peripheral blood as part of a GMP-
compliant manufacturing process that gains regulatory approval as a 
personalized cancer treatment option.
 The immunotherapy component of a combination cancer therapy 
regimen targeting specific tumor antigens in individual patients.
 More rapid tumor-reactive T cell culturing process for 
laboratory testing.

    Competitive Advantages:

 Simpler: Tumor-reactive T cells can be selected for ACT from a 
bulk population derived from peripheral blood sample using common 
laboratory techniques.
 More rapid: Selection of T cells based on expression of 
specific cell surface markers will reduce the culture time for these T 
cells before reinfusion into the patient to fight the tumor.
 Less screening: This selection method eliminates the need to 
screen T cells for autologous tumor recognition before re-infusion into 
the patient.

    Development Stage:

 Early-stage
 In vitro data available
    Inventors: Alena Gros and Steven A. Rosenberg (NCI)
    Intellectual Property: HHS Reference No. E-085-2013/0--
 U.S. Provisional Application No. 61/771,251 filed 01 March 
2013
 PCT Application No. PCT/US2013/38813 filed 30 April 2013

    Related Technologies: HHS Reference No. E-059-2013--


[[Page 7217]]


 US Provisional Application No. 61/771,247 filed 01 March 2013
 PCT Application No. PCT/US2013/038799 filed 30 April 2013

    Licensing Contact: Whitney A. Hastings; 301-451-7337; 
[email protected]

    Dated: January 31, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-02490 Filed 2-5-14; 8:45 am]
BILLING CODE 4140-01-P