Prospective Grant of an Exclusive Patent License: Development and Commercialization of T Cell Therapies for Mesothelin-Expressing Cancers, 55626-55627 [2021-21846]

Download as PDF 55626 Federal Register / Vol. 86, No. 191 / Wednesday, October 6, 2021 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting Prospective Grant of an Exclusive Patent License: Development and Commercialization of T Cell Therapies for Mesothelin-Expressing Cancers 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. jspears on DSK121TN23PROD with NOTICES1 Name of Committee: National Institute of Child Health and Human Development Initial Review Group; Pediatrics Study Section. Date: October 7, 2021. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6710B Rockledge Drive, Room 2137B, Bethesda, MD 20892 (Video Assisted Meeting). Contact Person: Joanna Kubler-Kielb, Ph.D., Scientific Review Officer, Scientific Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6710B Rockledge Drive, Room 2137B, Bethesda, MD 20892, (301) 435–6916, kielbj@ mail.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. 93.865, Research for Mothers and Children, National Institutes of Health, HHS) Dated: October 1, 2021. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–21855 Filed 10–5–21; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 20:38 Oct 05, 2021 Jkt 256001 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 Ares Immunotherapy, Inc. (‘‘Ares’’), a Delaware corporation. 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 October 21, 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: Intellectual Property E–078–2012: Anti-Mesothelin Chimeric Antigen Receptors 1. United States Provisional Patent Application No. 61/614,612 filed March 23, 2012 (NCI Reference E–078–2012–0– US–01); 2. PCT Patent Application No. PCT/ US2013/028980 filed March 5, 2013 (NCI Reference E–078–2012–0–PCT–02); 3. Australian Patent No. 2013235726 issued August 3, 2017 (NCI Reference E–078–2012–0–AU–03); 4. Canadian Patent No. 2,868,121 issued June 1, 2021 (NCI Reference E– 078–2012–0–CA–04); 5. European Patent No. 2828290 issued August 15, 2018 (NCI Reference E–078–2012–0–EP–05); a. Validated in: FR, DE and UK 6. United States Patent No. 9,359,447 issued June 7, 2016 (NCI Reference E– 078–2012–0–US–06); 7. European Patent No. 3421489 issued May 5, 2021 (NCI Reference E– 078–2012–0–EP–07); and PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 a. Validated in: FR, DE and UK 8. Canadian Patent Application No. 3,116,051 filed April 23, 2021 (NCI Reference E–078–2012–0–CA–11). 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 field of use may be limited to the following: ‘‘Development, manufacture and commercialization of T cell therapy products engineered to express the chimeric antigen receptor(s) claimed in the Licensed Patent Rights for the treatment of mesothelin-expressing cancers in humans.’’ The E–078–2012 invention family discloses certain chimeric antigen receptors (CARs) targeting mesothelin. CARs are synthetic proteins comprised of extracellular antigen binding domains and intracellular signaling domains designed to activate the cytolytic functions of CAR-expressing T cells upon antigen recognition. Mesothelin is a cell surface protein. Its expression is primarily restricted to mesothelial cells of the pleura, peritoneum, and pericardium; however, research has demonstrated that several cancers, including malignant mesothelioma, pancreatic, ovarian and lung adenocarcinoma, also express mesothelin under certain circumstances. Due to its limited expression in normal tissues, CARs targeting mesothelin may be useful in the development of T cell therapy products for the treatment of select cancers. 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 E:\FR\FM\06OCN1.SGM 06OCN1 Federal Register / Vol. 86, No. 191 / Wednesday, October 6, 2021 / Notices Freedom of Information Act, 5 U.S.C. 552. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: October 1, 2021. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. National Institutes of Health Center for Scientific Review; Notice of Closed Meetings [FR Doc. 2021–21846 Filed 10–5–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting jspears on DSK121TN23PROD with NOTICES1 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; RFP NIHAI75N93021R00010 Division of Microbiology and Infectious Diseases: Regulatory Affairs Support (N01). Date: November 2, 2021. Time: 1:00 p.m. to 3:30 p.m. Agenda: To review and evaluate contract proposals. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3E70A, Rockville, MD 20892 (Virtual Meeting). Contact Person: Annie Walker-Abbey, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3E70A, Rockville, MD 20852, 240–627–3390, aabbey@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: October 1, 2021. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–21839 Filed 10–5–21; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 20:38 Oct 05, 2021 Jkt 256001 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: Center for Scientific Review Special Emphasis Panel; PAR–20– 153: Science Education Partnership Award (SEPA) (R25). Date: November 4–5, 2021. Time: 11:00 a.m. to 8:00 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: Thomas Y. Cho, Ph.D., Scientific Review Officer, Center for Scientific Review, 6701 Rockledge Drive, Rm. 5144, MSC 7840, Bethesda, MD 20892, (301) 402–4179, thomas.cho@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Health Informatics. Date: November 8, 2021. Time: 9:00 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: Jacinta Bronte-Tinkew, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3164, MSC 7770, Bethesda, MD 20892, (301) 806– 0009, Jacinta.bronte-tinkew@nih.gov. Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Neural Oxidative Metabolism and Death Study Section. Date: November 8–10, 2021. Time: 9:00 a.m. to 9:00 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: Carol Hamelink, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4192, MSC 7850, Bethesda, MD 20892, (301) 213– 9887, hamelinc@csr.nih.gov. PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 55627 Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Cancer Diagnostics and Treatments (CDT). Date: November 8–9, 2021. Time: 9:00 a.m. to 8:00 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: Victor A. Panchenko, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 802B2, Bethesda, MD 20892, (301) 867–5309, victor.panchenko@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Antiviral Drug Discovery and Mechanisms of Resistance. Date: November 9–10, 2021. Time: 9:00 a.m. to 5:00 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: Shinako Takada, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301–402–9448, shinako.takada@ nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Skin Biology, Rheumatology, and Inflammation. Date: November 9, 2021. Time: 12:00 p.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: Srikanth Ranganathan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7802, Bethesda, MD 20892, (301) 435– 1787, srikanth.ranganathan@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Bioengineering Science and Technology. Date: November 12, 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: James J. Li, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5148, MSC 7849, Bethesda, MD 20892, 301–806– 8065, lijames@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Bioengineering, Surgery, Anesthesiology and Trauma. Date: November 12, 2021. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\06OCN1.SGM 06OCN1

Agencies

[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Pages 55626-55627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21846]


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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 T Cell Therapies for Mesothelin-Expressing Cancers

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 Ares 
Immunotherapy, Inc. (``Ares''), a Delaware corporation.

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 October 21, 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

E-078-2012: Anti-Mesothelin Chimeric Antigen Receptors

    1. United States Provisional Patent Application No. 61/614,612 
filed March 23, 2012 (NCI Reference E-078-2012-0-US-01);
    2. PCT Patent Application No. PCT/US2013/028980 filed March 5, 2013 
(NCI Reference E-078-2012-0-PCT-02);
    3. Australian Patent No. 2013235726 issued August 3, 2017 (NCI 
Reference E-078-2012-0-AU-03);
    4. Canadian Patent No. 2,868,121 issued June 1, 2021 (NCI Reference 
E-078-2012-0-CA-04);
    5. European Patent No. 2828290 issued August 15, 2018 (NCI 
Reference E-078-2012-0-EP-05);
a. Validated in: FR, DE and UK
    6. United States Patent No. 9,359,447 issued June 7, 2016 (NCI 
Reference E-078-2012-0-US-06);
    7. European Patent No. 3421489 issued May 5, 2021 (NCI Reference E-
078-2012-0-EP-07); and
a. Validated in: FR, DE and UK
    8. Canadian Patent Application No. 3,116,051 filed April 23, 2021 
(NCI Reference E-078-2012-0-CA-11).
    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 field of use may be limited to the following:
    ``Development, manufacture and commercialization of T cell therapy 
products engineered to express the chimeric antigen receptor(s) claimed 
in the Licensed Patent Rights for the treatment of mesothelin-
expressing cancers in humans.''
    The E-078-2012 invention family discloses certain chimeric antigen 
receptors (CARs) targeting mesothelin. CARs are synthetic proteins 
comprised of extracellular antigen binding domains and intracellular 
signaling domains designed to activate the cytolytic functions of CAR-
expressing T cells upon antigen recognition.
    Mesothelin is a cell surface protein. Its expression is primarily 
restricted to mesothelial cells of the pleura, peritoneum, and 
pericardium; however, research has demonstrated that several cancers, 
including malignant mesothelioma, pancreatic, ovarian and lung 
adenocarcinoma, also express mesothelin under certain circumstances. 
Due to its limited expression in normal tissues, CARs targeting 
mesothelin may be useful in the development of T cell therapy products 
for the treatment of select cancers.
    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

[[Page 55627]]

Freedom of Information Act, 5 U.S.C. 552.

    Dated: October 1, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-21846 Filed 10-5-21; 8:45 am]
BILLING CODE 4140-01-P
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