Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer, 23732-23733 [2021-09333]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 23732 Federal Register / Vol. 86, No. 84 / Tuesday, May 4, 2021 / Notices Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowship: Infectious Disease and Immunology B. Date: May 20, 2021. Time: 10:00 a.m. to 11:30 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Uma Basavanna, Ph.D., Scientific Review Officer, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301–435–1199, uma.basavanna@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. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA RM20– 022: Faculty Institutional Recruitment for Sustainable Transformation (FIRST) Program. Date: June 4, 2021. Time: 9:30 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Elia K. Ortenberg, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3108, MSC 7816, Bethesda, MD 20892, (301) 827– 7189, femiaee@csr.nih.gov. Name of Committee: Cardiovascular and Respiratory Sciences Integrated Review Group; Cardiovascular Differentiation and Development Study Section. Date: June 7, 2021. Time: 9:30 a.m. to 7:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Sara Ahlgren, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4136, Bethesda, MD 20817–7814, 301–435–0904, sara.ahlgren@nih.gov. Name of Committee: Biological Chemistry and Macromolecular Biophysics Integrated Review Group; Synthetic and Biological Chemistry A Study Section. Date: June 8–9, 2021. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Anita Szajek, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4187, Bethesda, MD 20892, 301–827–6276, anita.szajek@nih.gov. Name of Committee: Oncology 1-Basic Translational Integrated Review Group; Cancer Genetics Study Section. Date: June 10–11, 2021. Time: 9:00 a.m. to 5:00 p.m. VerDate Sep<11>2014 17:13 May 03, 2021 Jkt 253001 Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Juraj Bies, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4158, MSC 7806, Bethesda, MD 20892, 301–435–1256, biesj@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: April 29, 2021. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–09327 Filed 5–3–21; 8:45 am] 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; SenescenceCell Death Decisions in Aging. Date: June 4, 2021. Time: 12:30 p.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Video Meeting). Contact Person: Joshua Jin-Hyouk Park, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, National Institutes of Health, Gateway Building 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892, (301) 496–6208, joshua.park4@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Frm 00063 Fmt 4703 [FR Doc. 2021–09328 Filed 5–3–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Ziopharm Oncology, Inc. (‘‘Ziopharm’’), headquartered in Boston, MA. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before May 19, 2021 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Andrew Burke, Ph.D., Senior Technology Transfer Manager, NCI Technology Transfer Center, Telephone: (240) 276–5484; Email: andy.burke@nih.gov. SUPPLEMENTARY INFORMATION: SUMMARY: BILLING CODE 4140–01–P PO 00000 Dated: April 28, 2021. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. Sfmt 4703 Intellectual Property Group A E–190–2020: HLA Class I-Restricted T Cell Receptors Against RAS With G12V Mutation 1. United States Provisional Patent Application No. 63/060,340, filed August 3, 2020 (NCI Reference E–190– 2020–0–US–01) and U.S., PCT and foreign patent applications claiming priority to the aforementioned application. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be worldwide, and the E:\FR\FM\04MYN1.SGM 04MYN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 86, No. 84 / Tuesday, May 4, 2021 / Notices fields of use may be limited to the following: Freedom of Information Act, 5 U.S.C. 552. Fields of Use Applying to Intellectual Property Group A Dated: April 13, 2021. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. ‘‘Development, manufacture and commercialization of autologous, peripheral blood T cell therapy products engineered by transposon-mediated gene transfer to express T cell receptors reactive to mutated KRAS, as claimed in the Licensed Patent Rights, for the treatment of human cancers. Specifically excluded from this field of use are, (a) retrovirally-engineered peripheral blood T cell therapy products for the treatment of human cancers, and (b) CRISPR-engineered peripheral blood T cell therapy products for the treatment of human cancers. Development, manufacture and commercialization of companion diagnostics approved or cleared by the FDA or equivalent foreign regulatory agency for Licensee-proprietary T cell therapy products.’’ Intellectual Property Group A is primarily directed to isolated T cell receptors (TCRs) reactive to mutated Kirsten rat sarcoma viral oncogene homolog (KRAS), within the context of several human leukocyte antigens (HLAs). Mutated KRAS, which plays a well-defined driver role in oncogenesis, is expressed by a variety of human cancers, including: Pancreatic, lung, endometrial, ovarian and prostate. Due to its restricted expression in precancerous and cancerous cells, this antigen may be targeted on mutant KRAS-expressing tumors with minimal normal tissue toxicity. 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 from these license applications will be made only as required and upon a request under the VerDate Sep<11>2014 17:13 May 03, 2021 Jkt 253001 [FR Doc. 2021–09333 Filed 5–3–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments AGENCY: National Institutes of Health, HHS. ACTION: Notice. This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is a virtual meeting and is open to the public. Written comments will be accepted and registration is required to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/165. DATES: Meeting: Scheduled for June 8, 2021, 12:30 p.m.–5:00 p.m. Eastern Daylight Time (EDT). Written Public Comment Submissions: Deadline is June 1, 2021. Registration for Oral Comments: Deadline is June 1, 2021. ADDRESSES: Meeting web page: The preliminary agenda, registration, and other meeting materials are available at https://ntp.niehs.nih.gov/go/165. Virtual Meeting: The URL for viewing the virtual meeting will be provided on the meeting web page. FOR FURTHER INFORMATION CONTACT: Dr. Sheena Scruggs, Designated Federal Official for the BSC, Office of Liaison, Policy and Review, Division of NTP, NIEHS, P.O. Box 12233, K2–03, Research Triangle Park, NC 27709. Phone: 984–287–3355, Fax: 301–451– 5759, Email: sheena.scruggs@nih.gov. Hand Deliver/Courier address: 530 Davis Drive, Room K2130, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: The BSC will provide input to the NTP on programmatic activities and issues. The preliminary agenda topics include presentations from two of the Division of the National Toxicology Program SUMMARY: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 23733 (DNTP)’s research program areas. The preliminary agenda, roster of BSC members, background materials, public comments, and any additional information, when available, will be posted on the BSC meeting web page (https://ntp.niehs.nih.gov/go/165) or may be requested in hardcopy from the Designated Federal Official for the BSC. Following the meeting, summary minutes will be prepared and made available on the BSC meeting web page. Meeting Attendance Registration: The meeting is open to the public with time scheduled for oral public comments. Registration is not required to view the virtual meeting; the URL for the virtual meeting is provided on the BSC meeting web page (https://ntp.niehs.nih.gov/go/ 165). TTY users should contact the Federal TTY Relay Service at 800–877– 8339. Requests should be made at least five business days in advance of the event. Written Public Comments: NTP invites written public comments. Guidelines for public comments are available at https://ntp.niehs.nih.gov/ ntp/about_ntp/guidelines_public_ comments_508.pdf. The deadline for submission of written comments is June 1, 2021. Written public comments should be submitted through the meeting web page. Persons submitting written comments should include name, affiliation, mailing address, phone, email, and sponsoring organization (if any). Written comments received in response to this notice will be posted on the NTP web page, and the submitter will be identified by name, affiliation, and sponsoring organization (if any). Oral Public Comment Registration: The agenda allows for two formal public comment periods—one comment period for each program area (up to 3 commenters, up to 5 minutes per speaker, per topic). Persons wishing to make an oral comment are required to register online at https:// ntp.niehs.nih.gov/go/165 by June 1, 2021. Oral comments will be received only during the formal comment periods indicated on the preliminary agenda. Oral comments will only be by teleconference line. The access number for the teleconference line will be provided to registrants by email prior to the meeting. Registration is on a firstcome, first-served basis. Each organization is allowed one time slot per topic. After the maximum number of speakers per comment period is exceeded, individuals registered to provide oral comment will be placed on a wait list and notified should an opening become available. Commenters will be notified approximately one week E:\FR\FM\04MYN1.SGM 04MYN1

Agencies

[Federal Register Volume 86, Number 84 (Tuesday, May 4, 2021)]
[Notices]
[Pages 23732-23733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09333]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development and 
Commercialization of Cell Therapies for Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the Patents and Patent Applications listed in 
the Supplementary Information section of this Notice to Ziopharm 
Oncology, Inc. (``Ziopharm''), headquartered in Boston, MA.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before May 19, 2021 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Andrew Burke, Ph.D., Senior Technology Transfer 
Manager, NCI Technology Transfer Center, Telephone: (240) 276-5484; 
Email: [email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

Group A

E-190-2020: HLA Class I-Restricted T Cell Receptors Against RAS With 
G12V Mutation

    1. United States Provisional Patent Application No. 63/060,340, 
filed August 3, 2020 (NCI Reference E-190-2020-0-US-01) and U.S., PCT 
and foreign patent applications claiming priority to the aforementioned 
application.
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.
    The prospective exclusive license territory may be worldwide, and 
the

[[Page 23733]]

fields of use may be limited to the following:
Fields of Use Applying to Intellectual Property Group A
    ``Development, manufacture and commercialization of autologous, 
peripheral blood T cell therapy products engineered by transposon-
mediated gene transfer to express T cell receptors reactive to mutated 
KRAS, as claimed in the Licensed Patent Rights, for the treatment of 
human cancers. Specifically excluded from this field of use are, (a) 
retrovirally-engineered peripheral blood T cell therapy products for 
the treatment of human cancers, and (b) CRISPR-engineered peripheral 
blood T cell therapy products for the treatment of human cancers.
    Development, manufacture and commercialization of companion 
diagnostics approved or cleared by the FDA or equivalent foreign 
regulatory agency for Licensee-proprietary T cell therapy products.''
    Intellectual Property Group A is primarily directed to isolated T 
cell receptors (TCRs) reactive to mutated Kirsten rat sarcoma viral 
oncogene homolog (KRAS), within the context of several human leukocyte 
antigens (HLAs). Mutated KRAS, which plays a well-defined driver role 
in oncogenesis, is expressed by a variety of human cancers, including: 
Pancreatic, lung, endometrial, ovarian and prostate. Due to its 
restricted expression in precancerous and cancerous cells, this antigen 
may be targeted on mutant KRAS-expressing tumors with minimal normal 
tissue toxicity.
    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 from 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: April 13, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-09333 Filed 5-3-21; 8:45 am]
BILLING CODE 4140-01-P

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