Prospective Grant of Exclusive Patent License: T-Cells Transduced with HLA A11 Restricted CT-RCC HERV-E Reactive T-Cell Receptors for the Treatment of Renal Cell Carcinoma, 56622-56623 [2017-25743]

Download as PDF 56622 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices pmangrum on DSK3GDR082PROD with NOTICES1 concatenated L2 peptides for the prevention of Human Papillomavirus (HPV) infection and associated diseases. Specifically excluded from the field of use are L2 based virus-like particles (VLPs), L1/L2 chimeric peptides, and L1/L2 chimeric peptide/protein based VLPs.’’ The subject technologies are papillomavirus L2 capsid protein based vaccines against HPV. The L2 protein is the minor papillomavirus capsid protein for papillomaviruses. It is known that antibodies to this protein can neutralize homologous infection. Furthermore, L2 proteins can induce cross-neutralizing antibodies. Specifically, epitopes at the N-terminus of L2 shared by cutaneous and mucosal types of papillomavirus types and by types that infect divergent species are broadly cross-neutralizing. These epitopes at the N-terminus of L2 can be used to elicit cross-neutralizing antibodies against different types of HPV. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute 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. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: November 14, 2017. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2017–25744 Filed 11–28–17; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI SPORE V Review. Date: February 5–6, 2018. Time: 4:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Gaithersburg Washingtonian Marriott, 9751 Washingtonian Boulevard, Gaithersburg, MD 20878. Contact Person: Mukesh Kumar, Ph.D., Scientific Review Officer, Research Program Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W618, Bethesda, MD 20892–9750, 240–276–6611, mukesh.kumar3@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Molecular and Cellular Analysis Technologies. Date: February 8, 2018. Time: 10:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 7W030, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Nadeem Khan, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W260, Bethesda, MD 20892– 9750, 240–276–5856, nadeem.khan@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI SPORE VI Review. Date: February 8–9, 2018. Time: 4:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Gaithersburg Washingtonian Marriott, 9751 Washingtonian Boulevard, Gaithersburg, MD 20878. Contact Person: Anita T. Tandle, Ph.D., Scientific Review Officer, Research Program Review Branch, Division of Extramural PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W248, Bethesda, MD 20892–9750, 240–276–5007, tandlea@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Quantitative Imaging. Date: February 14, 2018. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 4W030, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Eduardo E. Chufan, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W254, Bethesda, MD 20892– 9750, 240–276–7975, chufanee@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: November 22, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–25732 Filed 11–28–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: T-Cells Transduced with HLA A11 Restricted CT–RCC HERV–E Reactive T-Cell Receptors for the Treatment of Renal Cell Carcinoma National Institutes of Health. Notice. AGENCY: ACTION: The National Heart, Lung, and Blood Institute (‘‘NHLBI’’), an institute of the National Institutes of Health; an agency within the Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to commercialize the invention(s) embodied in the intellectual property estate stated in the Summary Information section of this notice to T-Cure Bioscience, Inc. located in Thousand Oaks, California and incorporated under the laws of Delaware. DATES: Only written comments and/or applications for a license which are received by the NHLBI Office of Technology Transfer and Development SUMMARY: E:\FR\FM\29NON1.SGM 29NON1 pmangrum on DSK3GDR082PROD with NOTICES1 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices on or before December 14, 2017 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive license should be directed to: Cristina Thalhammer-Reyero, Ph.D., MBA, Senior Licensing and Patenting Manager, NHLBI Office of Technology Transfer and Development, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892–2479; Telephone: +1–301– 435–4507; Fax: +1–301–594–3080; Email: thalhamc@mail.nih.gov. SUPPLEMENTARY INFORMATION: The following represents the intellectual property to be licensed under the prospective agreement: US Provisional Patent Application No. 62/357,265, filed June 30, 2016; and PCT Patent Application PCT/US2017/ 040449, filed June 30, 2017, ‘‘HERV–E Reactive T Cell Receptors and Methods of Use’’, NIH Reference No. E–120– 2016/0,1. With respect to persons who have an obligation to assign their right, title and interest to the Government of the United States of America, 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 may be limited to the use of Licensed Patent Rights for the following: ‘‘Development and commercialization of T cell receptor based cancer immunotherapy for Renal Cell Carcinoma’’. The subject technology is based on an allogeneic T cell clone isolated 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. The 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. More than 80% of ccRCC tumors express CT–RCC HERV–E provirus, which makes it an ideal target for T cell based immunotherapy. The genes for a T cell receptor (TCR) that specifically recognizes an HLA–A11 restricted CT– RCC–1 antigen were sequenced and cloned. 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, was VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 created. The vector can be used to transduce and expand normal T cells from HLA–A11 patients with metastatic ccRCC with the TCR. 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. Phase I/ II clinical trials are currently being planned in patients with metastatic ccRCC using normal patient’s T-cells transduced with this vector. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective Exclusive Patent License will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, the NHLBI Office of Technology Transfer and Development 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. The public may file comments or objections in response to this Notice. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: November 16, 2017. Cristina Thalhammer-Reyero, Senior Licensing and Patenting Manager, Office of Technology Transfer and Development, National Heart, Lung, and Blood Institute. [FR Doc. 2017–25743 Filed 11–28–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent Commercialization License: N6, A Novel, Broad, Highly Potent HIVSpecific Antibody AGENCY: ACTION: PO 00000 National Institutes of Health. Notice. Frm 00044 Fmt 4703 Sfmt 4703 56623 The National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent commercialization license to GlaxoSmithKline Intellectual Property Development Ltd (GSK) located at 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice. DATES: Only written comments and/or applications for a license which are received by the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases on or before December 14, 2017 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated exclusive patent commercialization license should be directed to: Chris Kornak, Lead Technology Transfer and Patent Specialist, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Suite 6D, MSC 9804, Rockville, MD 20852–9804, phone number 301–496– 2644, or chris.kornak@nih.gov. SUPPLEMENTARY INFORMATION: The following represents the intellectual property to be licensed under the prospective agreement: HHS Reference No. E–131–2015/0–US–01, United States Provisonal Patent Application Serial No. 62/136,228, filed on 03/20/ 2015; HHS Reference No. E–131–2015/ 1–US–01, United States Provisional Patent Application Serial No. 62/ 250,378 filed on 11/03/2015; HHS Reference No. E–131–2015/2–PCT–01, PCT Patent Application Serial No. PCT/ US2016/023145, filed on 03/18/2016; HHS Reference No. E–131–2015/2–US– 07, United States Patent Application Serial No. 15/559,791, filed on 09/19/ 2017; HHS Reference No. E–131–2015/ 2–EP–05, European Patent Application Serial No. 16716979.6, filed on 10/19/ 2017; HHS Reference No. E–131–2015/ 2–CA–03, Canadian Patent Application Serial No. 2,980,005, filed on 09/15/ 2017; HHS Reference No. E–131–2015/ 2–AU–02, Australian Patent Application Serial No. 2016235541, filed on 09/08/ 2017; HHS Reference No. E–131–2015/ 2–CN–04, filing in process, HHS Reference No. E–131–2015/2–ZA–08, South African Patent Application Serial No. 2017/06155, filed on 09/11/2017; and HHS Reference No. E–131–2015/ 2–IN–06, Indian Patent Application SUMMARY: E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56622-56623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25743]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: T-Cells Transduced 
with HLA A11 Restricted CT-RCC HERV-E Reactive T-Cell Receptors for the 
Treatment of Renal Cell Carcinoma

AGENCY: National Institutes of Health.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Heart, Lung, and Blood Institute (``NHLBI''), an 
institute of the National Institutes of Health; an agency within the 
Department of Health and Human Services, is contemplating the grant of 
an Exclusive Patent License to commercialize the invention(s) embodied 
in the intellectual property estate stated in the Summary Information 
section of this notice to T-Cure Bioscience, Inc. located in Thousand 
Oaks, California and incorporated under the laws of Delaware.

DATES: Only written comments and/or applications for a license which 
are received by the NHLBI Office of Technology Transfer and Development

[[Page 56623]]

on or before December 14, 2017 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Cristina Thalhammer-Reyero, Ph.D., MBA, Senior Licensing 
and Patenting Manager, NHLBI Office of Technology Transfer and 
Development, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-
2479; Telephone: +1-301-435-4507; Fax: +1-301-594-3080; Email: 
thalhamc@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement:
    US Provisional Patent Application No. 62/357,265, filed June 30, 
2016; and PCT Patent Application PCT/US2017/040449, filed June 30, 
2017, ``HERV-E Reactive T Cell Receptors and Methods of Use'', NIH 
Reference No. E-120-2016/0,1.
    With respect to persons who have an obligation to assign their 
right, title and interest to the Government of the United States of 
America, 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 may be limited to the use of Licensed Patent Rights 
for the following: ``Development and commercialization of T cell 
receptor based cancer immunotherapy for Renal Cell Carcinoma''.
    The subject technology is based on an allogeneic T cell clone 
isolated 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. The 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. More than 80% of ccRCC tumors 
express CT-RCC HERV-E provirus, which makes it an ideal target for T 
cell based immunotherapy. The genes for a T cell receptor (TCR) that 
specifically recognizes an HLA-A11 restricted CT-RCC-1 antigen were 
sequenced and cloned. 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, 
was created. The vector can be used to transduce and expand normal T 
cells from HLA-A11 patients with metastatic ccRCC with the TCR. 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. Phase I/II clinical trials are 
currently being planned in patients with metastatic ccRCC using normal 
patient's T-cells transduced with this vector.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective Exclusive Patent License will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the NHLBI Office of Technology Transfer 
and Development 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.
    The public may file comments or objections in response to this 
Notice. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially, and may be 
made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: November 16, 2017.
Cristina Thalhammer-Reyero,
Senior Licensing and Patenting Manager, Office of Technology Transfer 
and Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2017-25743 Filed 11-28-17; 8:45 am]
 BILLING CODE 4140-01-P