82_FR_22647 82 FR 22554 - Government-Owned Invention; Availability for Licensing

82 FR 22554 - Government-Owned Invention; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 93 (May 16, 2017)

Page Range22554-22554
FR Document2017-09792

The inventions listed below are owned by an agency of the U.S. Government.

Federal Register, Volume 82 Issue 93 (Tuesday, May 16, 2017) 
[Federal Register Volume 82, Number 93 (Tuesday, May 16, 2017)]
[Notices]
[Page 22554]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-09792]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Invention; 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.

FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained 
by emailing the indicated licensing contact at the National Heart, 
Lung, and Blood, Office of Technology Transfer and Development Office 
of Technology Transfer, 31 Center Drive Room 4A29, MSC 2479, Bethesda, 
MD 20892-2479; telephone: 301-402-5579. A signed Confidential 
Disclosure Agreement may be required to receive any unpublished 
information.

SUPPLEMENTARY INFORMATION: The following inventions are available for 
licensing 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. Technology description follows.

T-Cells Transduced With HLA A11 Restricted CT-RCC HERV-E Reactive TCR 
To Treat Patients With ccRCC

    Description of Technology: We isolated an allogeneic T cell clone 
from a clear cell renal cell carcinoma (ccRCC) HLA-A11 patient who 
showed prolonged tumor regression after an allogeneic transplant. This 
clone was found to have tumor specific cytotoxicity, killing patient's 
tumor cells in vitro. We found that antigen recognized by this clone is 
an HLA-A11 restricted peptide (named CT-RCC-1) and it is encoded by a 
novel human endogenous retrovirus-E (named CT-RCC HERV-E) whose 
expression was discovered to be restricted to ccRCC, but not observed 
in normal tissues or other tumor types. We observed that more than 80% 
of ccRCC tumors express CT-RCC HERV-E provirus, which makes it an ideal 
target for T cell based immunotherapy. We have sequenced and cloned the 
genes for a T cell receptor (TCR) that specifically recognizes an HLA-
A11 restricted CT-RCC-1 antigen. We then created a retroviral vector 
encoding this TCR as well as a truncated CD34 protein lacking the 
intracellular domain, which can be used to facilitate the isolation of 
T-cells transduced with this TCR. Phase I/II clinical trials are 
currently being planned in patients with metastatic ccRCC using normal 
patient's T-cells transduced with this vector.
    Potential Commercial Applications: The vector can be used to 
transduce and expand normal T cells from HLA-A11 patients with 
metastatic ccRCC with the TCR recognizing HLA-A11-restricted CT-RCC 
HERV-E antigen that specifically expressed on clear cell type of kidney 
cancer. The transduced cytotoxic T cells can then be administered to 
subjects to treat or inhibit metastatic kidney cancer. Kidney cancer is 
responsible for approximately 12,000 deaths every year in the United 
States alone. As with most cancer, when detected at early stages, 
surgical intervention is highly effective. Despite progress in treating 
kidney cancer with IL-2 and inhibitors of immune checkpoints, 
metastatic ccRCC is generally lethal, with mean survival being less 
than a year. Patients with melanoma and other malignancies can now 
benefit from adoptive T cell transfer. One of the limitations of this 
approach for metastatic kidney cancer is a lack of identified tumor 
restricted antigens for this tumor. We show that the CT-RCC HERV-E is 
expressed in most ccRCC tumors but not in normal tissues which makes 
the antigens encoded by this provirus ideal targets for T cell-based 
immunotherapy of ccRCC.
    Development Stage: Early-stage; In vitro data available.
    Inventors: Richard W. Childs and Elena Cherkasova (NHLBI), Michael 
Nishimura (Loyola University Chicago).
    Publications:
    1. Takahashi Y. et al. 2008. Regression of kidney cancer following 
allogeneic stem-cell transplantation associated with T-cells 
recognizing a HERV-E antigen. J. Clin. Invest. 118:1099-109.
    2. Cherkasova E. et al. 2011. Inactivation of the von Hippel-Lindau 
tumor suppressor leads to selective expression of a human endogenous 
retrovirus in kidney cancer. Oncogene 30:4697-706.
    3. Cherkasova E. et al. 2013. Endogenous retroviruses as targets 
for antitumor immunity in renal cell cancer and other tumors. Front. 
Oncol. 3:243-247.
    4. Cherkasova E. et al. 2016. Detection of a HERV-E envelope with 
selective expression in clear cell kidney cancer. Cancer Res. 76:2177-
2185.
    Intellectual Property: NIH Reference No. E-120-2016/0--US 
Application No. 62/357,265, filed June 30, 2016.
    Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301-
435-4507; [email protected].

    Dated: May 2, 2017.
Cristina Thalhammer-Reyero,
Senior Licensing and Patenting Manager, Office of Technology Transfer 
and Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2017-09792 Filed 5-15-17; 8:45 am]
 BILLING CODE 4140-01-P

22554 Federal Register / Vol. 82, No. 93 / Tuesday, May 16, 2017 / Notices Contact Person: Deborah Ismond, Ph.D., not observed in normal tissues or other 3. Cherkasova E. et al. 2013. Scientific Review Officer, Division of tumor types. We observed that more Endogenous retroviruses as targets for Scientific Programs, National Institute on than 80% of ccRCC tumors express CT– antitumor immunity in renal cell cancer Minority Health, and Health Disparities, RCC HERV–E provirus, which makes it and other tumors. Front. Oncol. 3:243– National Institutes of Health, 7201 Wisconsin Ave., Suite 525, Bethesda, MD 20814, (301) an ideal target for T cell based 247. 594–2704, ismonddr@mail.nih.gov/. immunotherapy. We have sequenced 4. Cherkasova E. et al. 2016. Detection and cloned the genes for a T cell of a HERV–E envelope with selective Dated: May 10, 2017. receptor (TCR) that specifically expression in clear cell kidney cancer. David Clary, recognizes an HLA–A11 restricted CT– Cancer Res. 76:2177–2185. Program Analyst, Office of Federal Advisory RCC–1 antigen. We then created a Intellectual Property: NIH Reference Committee Policy. retroviral vector encoding this TCR as No. E–120–2016/0—US Application No. [FR Doc. 2017–09786 Filed 5–15–17; 8:45 am] well as a truncated CD34 protein lacking 62/357,265, filed June 30, 2016. the intracellular domain, which can be Licensing Contact: Cristina BILLING CODE 4140–01–P used to facilitate the isolation of T-cells Thalhammer-Reyero, Ph.D., M.B.A.; transduced with this TCR. Phase I/II 301–435–4507; thalhamc@mail.nih.gov. DEPARTMENT OF HEALTH AND clinical trials are currently being Dated: May 2, 2017. HUMAN SERVICES planned in patients with metastatic Cristina Thalhammer-Reyero, ccRCC using normal patient’s T-cells Senior Licensing and Patenting Manager, National Institutes of Health transduced with this vector. Office of Technology Transfer and Potential Commercial Applications: Development, National Heart, Lung, and Government-Owned Invention; The vector can be used to transduce and Blood Institute. Availability for Licensing expand normal T cells from HLA–A11 [FR Doc. 2017–09792 Filed 5–15–17; 8:45 am] patients with metastatic ccRCC with the AGENCY: National Institutes of Health, BILLING CODE 4140–01–P TCR recognizing HLA–A11-restricted HHS. CT–RCC HERV–E antigen that ACTION: Notice. specifically expressed on clear cell type DEPARTMENT OF HEALTH AND SUMMARY: The inventions listed below of kidney cancer. The transduced HUMAN SERVICES are owned by an agency of the U.S. cytotoxic T cells can then be Government. administered to subjects to treat or National Institutes of Health inhibit metastatic kidney cancer. Kidney FOR FURTHER INFORMATION CONTACT: cancer is responsible for approximately National Institute of Arthritis and Licensing information may be obtained 12,000 deaths every year in the United Musculoskeletal and Skin Diseases; by emailing the indicated licensing States alone. As with most cancer, when Notice of Closed Meeting contact at the National Heart, Lung, and detected at early stages, surgical Blood, Office of Technology Transfer Pursuant to section 10(d) of the intervention is highly effective. Despite Federal Advisory Committee Act, as and Development Office of Technology progress in treating kidney cancer with Transfer, 31 Center Drive Room 4A29, amended (5 U.S.C. App.), notice is IL–2 and inhibitors of immune hereby given of the following meeting. MSC 2479, Bethesda, MD 20892–2479; checkpoints, metastatic ccRCC is telephone: 301–402–5579. A signed The meeting will be closed to the generally lethal, with mean survival public in accordance with the Confidential Disclosure Agreement may being less than a year. Patients with be required to receive any unpublished provisions set forth in sections melanoma and other malignancies can 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., information. now benefit from adoptive T cell as amended. The grant applications and SUPPLEMENTARY INFORMATION: The transfer. One of the limitations of this the discussions could disclose following inventions are available for approach for metastatic kidney cancer is confidential trade secrets or commercial licensing in accordance with 35 U.S.C. a lack of identified tumor restricted property such as patentable material, 209 and 37 CFR part 404 to achieve antigens for this tumor. We show that and personal information concerning expeditious commercialization of the CT–RCC HERV–E is expressed in individuals associated with the grant results of federally-funded research and most ccRCC tumors but not in normal applications, the disclosure of which development. Technology description tissues which makes the antigens would constitute a clearly unwarranted follows. encoded by this provirus ideal targets invasion of personal privacy. T-Cells Transduced With HLA A11 for T cell-based immunotherapy of Name of Committee: National Institute of Restricted CT–RCC HERV–E Reactive ccRCC. Arthritis and Musculoskeletal and Skin TCR To Treat Patients With ccRCC Development Stage: Early-stage; In Diseases Special Emphasis Panel; AMSC vitro data available. Review Conflict Meeting. Description of Technology: We Inventors: Richard W. Childs and Date: June 8, 2017. isolated an allogeneic T cell clone from Elena Cherkasova (NHLBI), Michael Time: 11:00 a.m. to 2:00 p.m. a clear cell renal cell carcinoma (ccRCC) Nishimura (Loyola University Chicago). Agenda: To review and evaluate grant HLA–A11 patient who showed Publications: applications. prolonged tumor regression after an 1. Takahashi Y. et al. 2008. Regression Place: 6701 Democracy Boulevard, allogeneic transplant. This clone was of kidney cancer following allogeneic Conference Room 803, Bethesda, MD 20892. found to have tumor specific stem-cell transplantation associated Contact Person: Yin Liu, Ph.D., M.D., cytotoxicity, killing patient’s tumor cells Scientific Review Officer, Scientific Review sradovich on DSK3GMQ082PROD with NOTICES with T-cells recognizing a HERV–E Branch, NIH/National Institute of Arthritis, in vitro. We found that antigen antigen. J. Clin. Invest. 118:1099–109. Musculoskeletal and Skin Diseases, 6701 recognized by this clone is an HLA–A11 2. Cherkasova E. et al. 2011. Democracy Boulevard, Suite 824, Bethesda, restricted peptide (named CT–RCC–1) Inactivation of the von Hippel-Lindau MD 20892, 301–451–4838, yin.liu@.nih.gov. and it is encoded by a novel human tumor suppressor leads to selective (Catalogue of Federal Domestic Assistance endogenous retrovirus-E (named CT– expression of a human endogenous Program Nos. 93.846, Arthritis, RCC HERV–E) whose expression was retrovirus in kidney cancer. Oncogene Musculoskeletal and Skin Diseases Research, discovered to be restricted to ccRCC, but 30:4697–706. National Institutes of Health, HHS) VerDate Sep<11>2014 16:42 May 15, 2017 Jkt 241001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\16MYN1.SGM 16MYN1


Document Created: 2017-05-16 13:52:55
Document Modified: 2017-05-16 13:52:55
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactLicensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive Room 4A29, MSC 2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information.
FR Citation82 FR 22554 
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