Prospective Grant of Exclusive Patent Commercialization License: N6, A Novel, Broad, Highly Potent HIV-Specific Antibody, 56623-56624 [2017-25745]

Download as PDF 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 pmangrum on DSK3GDR082PROD with NOTICES1 56624 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices Serial No. 201737032671, filed on 09/ 14/2017. All rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive patent commercialization license territory may be worldwide and the field of use may be limited to: ‘‘Administration to humans of a GP120-binding protein or proteins, containing the 6 CDRs of the N6 antibody, all as described in the Licensed Patent Rights. This field of use does not include bi-specific/multispecific constructs utilizing the Licensed Patent Rights.’’ The N6 antibody has evolved a unique mode of binding that depends less on a variable area of the HIV envelope known as the V5 region and focuses more on conserved regions, which change relatively little among HIV strains. This allows N6 to tolerate changes in the HIV envelope, including the attachment of sugars in the V5 region, a major mechanism by which HIV develops resistance to other VRC01class antibodies. N6 was shown in preclinical studies to neutralize approximately 98 percent of HIV isolates tested. The studies also demonstrate that N6 neutralizes approximately 80 percent of HIV isolates which were resistant to other antibodies of the same class, and does so very potently. Its breadth and potency makes N6 a highly desirable candidate for development in therapeutic or prophylactic strategies. An abstract of the subject invention was published in the Federal Register on March 13, 2017. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent commercialization license will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, the National Institute of Allergy and Infectious Diseases 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. Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent commercialization license. Comments and objections submitted in response to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 under the Freedom of Information Act, 5 U.S.C. 552. DEPARTMENT OF HEALTH AND HUMAN SERVICES Suzanne Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. National Institutes of Health [FR Doc. 2017–25745 Filed 11–28–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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 Institute on Aging Special Emphasis Panel; AD Sequencing II. Date: December 1, 2017. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, Suite 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20814 (Telephone Conference Call). Contact Person: Bita Nakhai, Ph.D., Scientific Review Branch, National Institute on Aging, Gateway Bldg., 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301–402–7701, nakhaib@nia.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: November 22, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–25734 Filed 11–28–17; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 National Center for Advancing Translational Sciences; Notice of Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of meetings of the National Center for Advancing Translational Sciences. The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. 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: Cures Acceleration Network Review Board. Date: January 11, 2018. Time: 8:30 a.m. to 3:00 p.m. Agenda: Report from the Institute Director. Place: National Institutes of Health, Building 31, Conference Room 10, 31 Center Drive, Bethesda, MD 20892. Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive Secretary, National Center for Advancing Translational Sciences, 1 Democracy Plaza, Room 1072, Bethesda, MD 20892, 301–435–0809, anna.ramseyewing@ nih.gov. Name of Committee: National Center for Advancing Translational Sciences Advisory Council. Date: January 11, 2018. Open: 8:30 a.m. to 3:00 p.m. Agenda: Report from the Institute Director and other staff. Place: National Institutes of Health, Building 31, Conference Room 10, 31 Center Drive, Bethesda, MD 20892. Closed: 3:15 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Building 31, Conference Room 10, 31 Center Drive, Bethesda, MD 20892. Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive Secretary, National Center for Advancing Translational Sciences, 1 Democracy Plaza, Room 1072, Bethesda, MD 20892, 301–435–0809, anna.ramseyewing@ nih.gov. E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56623-56624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25745]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent Commercialization License: 
N6, A Novel, Broad, Highly Potent HIV-Specific Antibody

AGENCY: National Institutes of Health.

ACTION: Notice.

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

SUMMARY: 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

[[Page 56624]]

Serial No. 201737032671, filed on 09/14/2017.
    All rights in these inventions have been assigned to the Government 
of the United States of America.
    The prospective exclusive patent commercialization license 
territory may be worldwide and the field of use may be limited to: 
``Administration to humans of a GP120-binding protein or proteins, 
containing the 6 CDRs of the N6 antibody, all as described in the 
Licensed Patent Rights. This field of use does not include bi-specific/
multi-specific constructs utilizing the Licensed Patent Rights.''
    The N6 antibody has evolved a unique mode of binding that depends 
less on a variable area of the HIV envelope known as the V5 region and 
focuses more on conserved regions, which change relatively little among 
HIV strains. This allows N6 to tolerate changes in the HIV envelope, 
including the attachment of sugars in the V5 region, a major mechanism 
by which HIV develops resistance to other VRC01-class antibodies. N6 
was shown in pre-clinical studies to neutralize approximately 98 
percent of HIV isolates tested. The studies also demonstrate that N6 
neutralizes approximately 80 percent of HIV isolates which were 
resistant to other antibodies of the same class, and does so very 
potently. Its breadth and potency makes N6 a highly desirable candidate 
for development in therapeutic or prophylactic strategies. An abstract 
of the subject invention was published in the Federal Register on March 
13, 2017.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent commercialization license 
will be royalty bearing and may be granted unless within fifteen (15) 
days from the date of this published notice, the National Institute of 
Allergy and Infectious Diseases 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.
    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent 
commercialization license. Comments and objections submitted in 
response 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.

Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-25745 Filed 11-28-17; 8:45 am]
 BILLING CODE 4140-01-P