83_FR_58485 83 FR 58262 - 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

83 FR 58262 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 223 (November 19, 2018)

Page Range58262-58263
FR Document2018-25197

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.

Federal Register, Volume 83 Issue 223 (Monday, November 19, 2018) 
[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Notices]
[Pages 58262-58263]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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

58262 Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices Services is hereby giving notice that the NBSB Chair will respond to comments Review Program, Division of Extramural National Biodefense Science Board received by December 12, 2018, during Activities, Room #3G40, National Institutes (NBSB) will hold a public the public teleconference. of Health/NIAID, 5601 Fishers Lane, MSC teleconference on December 13, 2018. 9823, Bethesda, MD 20892–7616, 240–669– Dated: November 8, 2018. DATES: The NBSB Public Teleconference 5066, pmehrotra@niaid.nih.gov. Robert P. Kadlec, is December 13, 2018, from 2:00 p.m. to (Catalogue of Federal Domestic Assistance Assistant Secretary for Preparedness and 4:00 p.m. Eastern Standard Time (EST). Response. Program Nos. 93.855, Allergy, Immunology, ADDRESSES: We encourage members of and Transplantation Research; 93.856, [FR Doc. 2018–25131 Filed 11–16–18; 8:45 am] the public to attend the public meetings. Microbiology and Infectious Diseases BILLING CODE 4150–28–P To register, send an email to nbsb@ Research, National Institutes of Health, HHS) hhs.gov with ‘‘NBSB Registration’’ in Dated: November 14, 2018. the subject line. Submit your comments DEPARTMENT OF HEALTH AND Natasha M. Copeland, to nbsb@hhs.gov, the NBSB Contact HUMAN SERVICES Program Analyst, Office of Federal Advisory Form located at https://www.phe.gov/ Committee Policy. Preparedness/legal/boards/nbsb/Pages/ National Institutes of Health [FR Doc. 2018–25191 Filed 11–16–18; 8:45 am] RFNBSBComments.aspx. For additional National Institute of Allergy and BILLING CODE 4140–01–P information, visit the NBSB website Infectious Diseases; Notice of Closed located at https://www.phe.gov/nbsb. Meetings SUPPLEMENTARY INFORMATION: The NBSB DEPARTMENT OF HEALTH AND is authorized under Section 319M of the Pursuant to section 10(d) of the HUMAN SERVICES Public PHS Act (42 U.S.C. 247d–7f), as Federal Advisory Committee Act, as added by Section 402 of the Pandemic amended, notice is hereby given of the National Institutes of Health and All-Hazards Preparedness Act of following meetings. 2006 and amended by Section 404 of the The meetings will be closed to the Prospective Grant of an Exclusive Pandemic and All-Hazards public in accordance with the Patent License: Development and Preparedness Reauthorization Act. The provisions set forth in sections Commercialization of Chimeric Antigen Board is governed by the Federal 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Receptor (CAR) Therapies for the Advisory Committee Act (5 U.S.C. as amended. The grant applications and Treatment of FMS-Like Tyrosine App.), which sets forth standards for the the discussions could disclose Kinase 3 (FLT3) Expressing Cancers formation and use of advisory confidential trade secrets or commercial committees. The NBSB provides expert property such as patentable material, AGENCY: National Institutes of Health, advice and guidance on scientific, and personal information concerning HHS. technical, and other matters of special individuals associated with the grant interest to the Department regarding applications, the disclosure of which ACTION: Notice. current and future chemical, biological, would constitute a clearly unwarranted nuclear, and radiological agents, invasion of personal privacy. SUMMARY: The National Cancer Institute, whether naturally occurring, accidental, Name of Committee: National Institute of an institute of the National Institutes of or deliberate. Allergy and Infectious Diseases Special Health, Department of Health and Background: The December 13, 2018, Emphasis Panel NIAID 2018 Omnibus BAA Human Services, is contemplating the NBSB public teleconference is (HHS–NIH–NIAID–BAA2018) Research Area grant of an Exclusive Patent License to dedicated to the discussion of 001: Development of Therapeutic Products practice the inventions embodied in the recommendations on two topics: (1) for Biodefense, Anti-Microbial Resistant Patents and Patent Applications listed (AMR) Infections and Emerging Infectious Strategic improvements to the National Diseases. in the Supplementary Information Disaster Medical System (NDMS) and Date: December 11–12, 2018. section of this Notice to ElevateBio. (2) implementation of the National Time: 10:00 a.m. to 4:00 p.m. (‘‘Elevate’’), located in Cambridge, MA. Biodefense Strategy. We will post Agenda: To review and evaluate contract modifications to the agenda on the proposals. DATES: Only written comments and/or NBSB meeting website, which is located Place: National Institutes of Health, 5601 applications for a license which are at https://www.phe.gov/nbsb. Fishers Lane, Rockville, MD 20892 received by the National Cancer Availability of Materials: We will post (Telephone Conference Call). Institute’s Technology Transfer Center Contact Person: Kumud K. Singh, Ph.D., on or before December 4, 2018 will be all teleconference materials prior to the Scientific Review Officer, Scientific Review considered. teleconference on December 13, 2018, at Program, DEA/NIAID/NIH/DHHS, 5601 the website located at https:// Fishers Lane, MSC–9823, Rockville, MD ADDRESSES: Requests for copies of the www.phe.gov/nbsb. 20852, 301–761–7830, kumud.singh@ patent applications, inquiries, and Procedures for Providing Public Input: nih.gov. comments relating to the contemplated Members of the public may attend the Name of Committee: National Institute of Exclusive Patent License should be public teleconference via a toll-free call- Allergy and Infectious Diseases Special directed to: Jim Knabb, Senior in phone number, which is available on Emphasis Panel NIAID Investigator Initiated Technology Transfer Manager, NCI the NBSB website at https:// Program Project Applications (P01). Date: December 11, 2018. Technology Transfer Center, 9609 www.phe.gov/nbsb. khammond on DSK30JT082PROD with NOTICES Time: 10:00 a.m. to 4:00 p.m. Medical Center Drive, RM 1E530, MSC We encourage members of the public 9702, Bethesda, MD 20892–9702 (for Agenda: To review and evaluate grant to provide written comments that are business mail), Rockville, MD 20850– applications. relevant to the NBSB public Place: National Institutes of Health, 5601 9702; Telephone: (240)-276–7856; teleconference prior to December 13, Fishers Lane, Rockville, MD 20892 Facsimile: (240)-276–5504; Email: 2018. Send written comments by email (Telephone Conference Call). jim.knabb@nih.gov. to nbsb@hhs.gov with ‘‘NBSB Public Contact Person: Priti Mehrotra, Ph.D., Comment’’ in the subject line. The Chief, Immunology Review Branch, Scientific SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:20 Nov 16, 2018 Jkt 247001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\19NON1.SGM 19NON1

Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices 58263 Intellectual Property presumed to contain business DEPARTMENT OF HEALTH AND confidential information and any release HUMAN SERVICES E–133–2016: FLT3-Specific Chimeric of information from these license Antigen Receptors and Methods Using National Institutes of Health applications will be made only as Same required and upon a request under the 1. US Provisional Patent Application Freedom of Information Act, 5 U.S.C. National Heart, Lung, and Blood 62/342,394, filed May 27, 2016 (E–133– 552. Institute; Notice of Meetings 2016–0–US–01); Pursuant to section 10(d) of the Dated: November 8, 2018. 2. International Patent Application Richard U. Rodriguez, Federal Advisory Committee Act, as PCT/US2017/034,691, filed May 26, Associate Director, Technology Transfer amended, notice is hereby given of the 2017 (E–133–2016–0–PCT–02) The patent rights in these inventions Center, National Cancer Institute. following meetings. [FR Doc. 2018–25197 Filed 11–16–18; 8:45 am] The meetings will be closed to the have been assigned and/or exclusively public in accordance with the licensed to the government of the BILLING CODE 4140–01–P provisions set forth in sections United States of America. The prospective exclusive license 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., territory may be worldwide, and the DEPARTMENT OF HEALTH AND as amended. The grant applications and fields of use may be limited to the HUMAN SERVICES the discussions could disclose following: confidential trade secrets or commercial ‘‘The development of a mono- or National Institutes of Health property such as patentable material, multi-specific FMS-like tyrosine kinase and personal information concerning Center for Scientific Review; Notice of individuals associated with the grant 3 (FLT3; also known as CD135) chimeric Closed Meeting applications, the disclosure of which antigen receptor (CAR)-based immunotherapy using autologous or Pursuant to section 10(d) of the would constitute a clearly unwarranted allogenic human lymphocytes (T cells Federal Advisory Committee Act, as invasion of personal privacy. or NK cells) transduced with lentiviral amended, notice is hereby given of the Name of Committee: National Heart, Lung, vectors, wherein the viral transduction following meeting. and Blood Institute Special Emphasis Panel; leads to the expression of a CAR that The meeting will be closed to the Catalyzing Innovation in Trial Design. targets FLT3 (comprised of the FLT3- public in accordance with the Date: December 6, 2018. binding domain referenced as NC7 in provisions set forth in sections Time: 10:00 a.m. to 10:30 a.m. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Agenda: To review and evaluate grant the invention as well as an intracellular applications. signaling domain), for the prophylaxis as amended. The grant applications and Place: National Institutes of Health, 6701 or treatment of FLT3-expressing the discussions could disclose Rockledge Drive, Room 7180, Bethesda, MD cancers.’’ confidential trade secrets or commercial 20892 (Telephone Conference Call). This technology discloses a CAR property such as patentable material, Contact Person: Tony L. Creazzo, Ph.D., vector that targets FLT3 comprised of an and personal information concerning Scientific Review Officer, Office of Scientific anti-FLT3 antibody known as NC7, and individuals associated with the grant Review, National Heart, Lung, and Blood an intracellular signaling domain. FLT3 applications, the disclosure of which Institute, National Institutes of Health, 6701 (CD135) is a cytokine receptor expressed would constitute a clearly unwarranted Rockledge Drive, Room 7180, Bethesda, MD invasion of personal privacy. 20892, 301–827–7913, creazzotl@ on hematopoietic progenitor cells, and mail.nih.gov. is one of the most frequently mutated Name of Committee: Center for Scientific Name of Committee: National Heart, Lung, genes in acute myeloid leukemia (AML) Review Special Emphasis Panel, PAR18–822: and Blood Institute Special Emphasis Panel; and infant acute lymphoblastic Approaches for Understanding Disease Catalyzing Innovation in Trial Design leukemia (ALL). FLT3 mutation leads to Mechanisms and Improving Outcomes in TB Resource Access. increased cell surface expression and Meningitis (TBM). Date: December 6, 2018. therefore on leukemic cells, which Date: December 12, 2018. Time: 10:30 a.m. to 12:00 p.m. makes it an attractive candidate for Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant Agenda: To review and evaluate grant applications. cellular therapies such as CAR–T. applications. Place: National Institutes of Health, 6701 This Notice is made in accordance Place: National Institutes of Health, 6701 Rockledge Drive, Room 7180, Bethesda, MD with 35 U.S.C. 209 and 37 CFR part 404. Rockledge Drive, Bethesda, MD 20892, The prospective exclusive license will 20892 (Telephone Conference Call). (Virtual Meeting). Contact Person: Tony L. Creazzo, Ph.D., be royalty bearing, and the prospective Contact Person: Guangyong Ji, Ph.D., Scientific Review Officer, Office of Scientific exclusive license may be granted unless Scientific Review Officer, Center for Review, National Heart, Lung, and Blood within fifteen (15) days from the date of Scientific Review, National Institutes of Institute, National Institutes of Health, 6701 this published Notice, the National Health, 6701 Rockledge Drive, Room 3211, Rockledge Drive, Room 7180, Bethesda, MD Cancer Institute receives written MSC 7808, Bethesda, MD 20892, 301–435– 20892, 301–827–7913, creazzotl@ evidence and argument that establishes 1146, jig@csr.nih.gov. mail.nih.gov. that the grant of the license would not (Catalogue of Federal Domestic Assistance Name of Committee: National Heart, Lung, be consistent with the requirements of Program Nos. 93.306, Comparative Medicine; and Blood Institute Special Emphasis Panel; 93.333, Clinical Research, 93.306, 93.333, Integrative Computational Biology for 35 U.S.C. 209 and 37 CFR part 404. 93.337, 93.393–93.396, 93.837–93.844, Analysis of NHLBI TOPMed Data. In response to this Notice, the public 93.846–93.878, 93.892, 93.893, National Date: December 7, 2018. khammond on DSK30JT082PROD with NOTICES may file comments or objections. Institutes of Health, HHS) Comments and objections, other than Time: 8:00 a.m. to 5:00 p.m. Dated: November 14, 2018. Agenda: To review and evaluate grant those in the form of a license applications. application, will not be treated Natasha M. Copeland, Place: Embassy Suites at the Chevy Chase confidentially, and may be made Program Analyst, Office of Federal Advisory Pavilion, 4300 Military Road NW, publicly available. Committee Policy. Washington, DC 20015. License applications submitted in [FR Doc. 2018–25196 Filed 11–16–18; 8:45 am] Contact Person: Susan Wohler Sunnarborg, response to this Notice will be BILLING CODE 4140–01–P Ph.D., Scientific Review Officer, Office of VerDate Sep<11>2014 17:20 Nov 16, 2018 Jkt 247001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\19NON1.SGM 19NON1


Document Created: 2018-11-17 02:46:59
Document Modified: 2018-11-17 02:46:59
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly 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.
FR Citation83 FR 58262 
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