Prospective Grant of an Exclusive Patent License: Development and Commercialization of Chimeric Antigen Receptor (CAR) Therapies for the Treatment of FMS-Like Tyrosine Kinase 3 (FLT3) Expressing Cancers, 58262-58263 [2018-25197]

Download as PDF khammond on DSK30JT082PROD with NOTICES 58262 Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices Services is hereby giving notice that the National Biodefense Science Board (NBSB) will hold a public teleconference on December 13, 2018. DATES: The NBSB Public Teleconference is December 13, 2018, from 2:00 p.m. to 4:00 p.m. Eastern Standard Time (EST). ADDRESSES: We encourage members of the public to attend the public meetings. To register, send an email to nbsb@ hhs.gov with ‘‘NBSB Registration’’ in the subject line. Submit your comments to nbsb@hhs.gov, the NBSB Contact Form located at https://www.phe.gov/ Preparedness/legal/boards/nbsb/Pages/ RFNBSBComments.aspx. For additional information, visit the NBSB website located at https://www.phe.gov/nbsb. SUPPLEMENTARY INFORMATION: The NBSB is authorized under Section 319M of the Public PHS Act (42 U.S.C. 247d–7f), as added by Section 402 of the Pandemic and All-Hazards Preparedness Act of 2006 and amended by Section 404 of the Pandemic and All-Hazards Preparedness Reauthorization Act. The Board is governed by the Federal Advisory Committee Act (5 U.S.C. App.), which sets forth standards for the formation and use of advisory committees. The NBSB provides expert advice and guidance on scientific, technical, and other matters of special interest to the Department regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. Background: The December 13, 2018, NBSB public teleconference is dedicated to the discussion of recommendations on two topics: (1) Strategic improvements to the National Disaster Medical System (NDMS) and (2) implementation of the National Biodefense Strategy. We will post modifications to the agenda on the NBSB meeting website, which is located at https://www.phe.gov/nbsb. Availability of Materials: We will post all teleconference materials prior to the teleconference on December 13, 2018, at the website located at https:// www.phe.gov/nbsb. Procedures for Providing Public Input: Members of the public may attend the public teleconference via a toll-free callin phone number, which is available on the NBSB website at https:// www.phe.gov/nbsb. We encourage members of the public to provide written comments that are relevant to the NBSB public teleconference prior to December 13, 2018. Send written comments by email to nbsb@hhs.gov with ‘‘NBSB Public Comment’’ in the subject line. The VerDate Sep<11>2014 17:20 Nov 16, 2018 Jkt 247001 NBSB Chair will respond to comments received by December 12, 2018, during the public teleconference. Dated: November 8, 2018. Robert P. Kadlec, Assistant Secretary for Preparedness and Response. [FR Doc. 2018–25131 Filed 11–16–18; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 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 Institute of Allergy and Infectious Diseases Special Emphasis Panel NIAID 2018 Omnibus BAA (HHS–NIH–NIAID–BAA2018) Research Area 001: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases. Date: December 11–12, 2018. Time: 10:00 a.m. to 4:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Kumud K. Singh, Ph.D., Scientific Review Officer, Scientific Review Program, DEA/NIAID/NIH/DHHS, 5601 Fishers Lane, MSC–9823, Rockville, MD 20852, 301–761–7830, kumud.singh@ nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel NIAID Investigator Initiated Program Project Applications (P01). Date: December 11, 2018. Time: 10:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Priti Mehrotra, Ph.D., Chief, Immunology Review Branch, Scientific Frm 00041 Fmt 4703 Sfmt 4703 Dated: November 14, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–25191 Filed 11–16–18; 8:45 am] National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings PO 00000 Review Program, Division of Extramural Activities, Room #3G40, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892–7616, 240–669– 5066, pmehrotra@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) 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 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of FMS-Like Tyrosine Kinase 3 (FLT3) Expressing Cancers 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 ElevateBio. (‘‘Elevate’’), located in Cambridge, MA. SUMMARY: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before December 4, 2018 will be considered. DATES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Jim Knabb, Senior Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530, MSC 9702, Bethesda, MD 20892–9702 (for business mail), Rockville, MD 20850– 9702; Telephone: (240)-276–7856; Facsimile: (240)-276–5504; Email: jim.knabb@nih.gov. ADDRESSES: SUPPLEMENTARY INFORMATION: E:\FR\FM\19NON1.SGM 19NON1 Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices khammond on DSK30JT082PROD with NOTICES Intellectual Property E–133–2016: FLT3-Specific Chimeric Antigen Receptors and Methods Using Same 1. US Provisional Patent Application 62/342,394, filed May 27, 2016 (E–133– 2016–0–US–01); 2. International Patent Application PCT/US2017/034,691, filed May 26, 2017 (E–133–2016–0–PCT–02) 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 fields of use may be limited to the following: ‘‘The development of a mono- or multi-specific FMS-like tyrosine kinase 3 (FLT3; also known as CD135) chimeric antigen receptor (CAR)-based immunotherapy using autologous or allogenic human lymphocytes (T cells or NK cells) transduced with lentiviral vectors, wherein the viral transduction leads to the expression of a CAR that targets FLT3 (comprised of the FLT3binding domain referenced as NC7 in the invention as well as an intracellular signaling domain), for the prophylaxis or treatment of FLT3-expressing cancers.’’ This technology discloses a CAR vector that targets FLT3 comprised of an anti-FLT3 antibody known as NC7, and an intracellular signaling domain. FLT3 (CD135) is a cytokine receptor expressed on hematopoietic progenitor cells, and is one of the most frequently mutated genes in acute myeloid leukemia (AML) and infant acute lymphoblastic leukemia (ALL). FLT3 mutation leads to increased cell surface expression and therefore on leukemic cells, which makes it an attractive candidate for cellular therapies such as CAR–T. 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 VerDate Sep<11>2014 17:20 Nov 16, 2018 Jkt 247001 58263 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 8, 2018. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. 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. [FR Doc. 2018–25197 Filed 11–16–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; 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: Center for Scientific Review Special Emphasis Panel, PAR18–822: Approaches for Understanding Disease Mechanisms and Improving Outcomes in TB Meningitis (TBM). Date: December 12, 2018. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Guangyong Ji, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3211, MSC 7808, Bethesda, MD 20892, 301–435– 1146, jig@csr.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: November 14, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–25196 Filed 11–16–18; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Meetings Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Catalyzing Innovation in Trial Design. Date: December 6, 2018. Time: 10:00 a.m. to 10:30 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Tony L. Creazzo, Ph.D., Scientific Review Officer, Office of Scientific Review, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892, 301–827–7913, creazzotl@ mail.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Catalyzing Innovation in Trial Design Resource Access. Date: December 6, 2018. Time: 10:30 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Tony L. Creazzo, Ph.D., Scientific Review Officer, Office of Scientific Review, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892, 301–827–7913, creazzotl@ mail.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Integrative Computational Biology for Analysis of NHLBI TOPMed Data. Date: December 7, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW, Washington, DC 20015. Contact Person: Susan Wohler Sunnarborg, Ph.D., Scientific Review Officer, Office of E:\FR\FM\19NON1.SGM 19NON1

Agencies

[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Notices]
[Pages 58262-58263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25197]


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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 Chimeric Antigen Receptor (CAR) Therapies for the 
Treatment of FMS-Like Tyrosine Kinase 3 (FLT3) 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 ElevateBio. 
(``Elevate''), located in Cambridge, 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 December 4, 2018 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: Jim Knabb, Senior Technology Transfer Manager, 
NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530, 
MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 
20850-9702; Telephone: (240)-276-7856; Facsimile: (240)-276-5504; 
Email: [email protected].

SUPPLEMENTARY INFORMATION: 

[[Page 58263]]

Intellectual Property

E-133-2016: FLT3-Specific Chimeric Antigen Receptors and Methods Using 
Same

    1. US Provisional Patent Application 62/342,394, filed May 27, 2016 
(E-133-2016-0-US-01);
    2. International Patent Application PCT/US2017/034,691, filed May 
26, 2017 (E-133-2016-0-PCT-02)
    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 fields of use may be limited to the following:
    ``The development of a mono- or multi-specific FMS-like tyrosine 
kinase 3 (FLT3; also known as CD135) chimeric antigen receptor (CAR)-
based immunotherapy using autologous or allogenic human lymphocytes (T 
cells or NK cells) transduced with lentiviral vectors, wherein the 
viral transduction leads to the expression of a CAR that targets FLT3 
(comprised of the FLT3-binding domain referenced as NC7 in the 
invention as well as an intracellular signaling domain), for the 
prophylaxis or treatment of FLT3-expressing cancers.''
    This technology discloses a CAR vector that targets FLT3 comprised 
of an anti-FLT3 antibody known as NC7, and an intracellular signaling 
domain. FLT3 (CD135) is a cytokine receptor expressed on hematopoietic 
progenitor cells, and is one of the most frequently mutated genes in 
acute myeloid leukemia (AML) and infant acute lymphoblastic leukemia 
(ALL). FLT3 mutation leads to increased cell surface expression and 
therefore on leukemic cells, which makes it an attractive candidate for 
cellular therapies such as CAR-T.
    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: November 8, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2018-25197 Filed 11-16-18; 8:45 am]
 BILLING CODE 4140-01-P

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