82 FR 22553 - Government-Owned Invention; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 93 (May 16, 2017)

Page Range		22553-22553
FR Document		2017-09791

The inventions listed below are owned by an agency of the U.S. Government.

Federal Register, Volume 82 Issue 93 (Tuesday, May 16, 2017)

[Federal Register Volume 82, Number 93 (Tuesday, May 16, 2017)]
[Notices]
[Page 22553]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-09791]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Invention; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government.

FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained 
by emailing the indicated licensing contact at the National Heart, 
Lung, and Blood, Office of Technology Transfer and Development Office 
of Technology Transfer, 31 Center Drive Room 4A29, MSC 2479, Bethesda, 
MD 20892-2479; telephone: 301-402-5579. A signed Confidential 
Disclosure Agreement may be required to receive any unpublished 
information.

SUPPLEMENTARY INFORMATION: The following inventions are available for 
licensing in accordance with 35 U.S.C. 209 and 37 CFR part 404 to 
achieve expeditious commercialization of results of federally-funded 
research and development. Technology description follows.

Efficient mRNA-Based Genetic Engineering of Human NK Cells With High-
Affinity CD16 and CCR7

    Description of Technology: A highly efficient method to genetically 
modify natural killer (NK) cells to induce expression of high affinity 
CD16 (HA-CD16) through mRNA electroporation, to potentiate NK cell-
mediated antibody-dependent cellular cytotoxicity (ADCC). ADCC is 
mediated by CD16\+\ NK cells following adoptive NK cell transfer, but 
most humans express CD16 which has a relatively low affinity for IgG1 
antibodies. However, a single nucleotide polymorphism (SNP rs396991) in 
the CD16 gene, resulting in an amino acid substitution at position 158 
(F158V), is associated with substantially higher affinity and superior 
NK cell-mediated ADCC than those with the 158F genotype. This HA-CD16-
158V polymorphism has also been linked to enhanced ADCC capacity in 
vivo. The nearly 100% efficiency of our method resulted in: (a) 
Sustained surface expression of transgenes at high levels for up to 4 
days without compromising NK cell cytotoxicity and viability; and (b) 
augmented ADCC against Daratumumab coated multiple myeloma cells by ex 
vivo expanded NK cells electroporated with mRNA coding for HA-CD16. 
This system is GMP compliant and has been used previously in FDA 
approved clinical trials.
    Potential Commercial Applications: Infusion of a large number of 
highly cytotoxic autologous ex vivo expanded NK cells expressing high-
affinity CD16 into patients, to induce a more profound anti-malignancy 
response to specific monoclonal antibodies, including: multiple myeloma 
(Daratumumab); lymphoma (Rituximab); breast cancer (Trastuzumab); and 
colon cancer (Cetuximab).
    Development Stage: Early-stage; In vitro data available.
    Inventors: Richard W. Childs and Mattias Carlsten (NHLBI).
    Publications:
    (1) Carlsten M, Levy E, Karambelkar A, Li L, Reger R, Berg M, 
Peshwa MV and Childs RW (2016) Efficient mRNA-Based Genetic Engineering 
of Human NK Cells with High-Affinity CD16 and CCR7 Augments Rituximab-
Induced ADCC against Lymphoma and Targets NK Cell Migration toward the 
Lymph Node-Associated Chemokine CCL19. Front. Immunol. 7:105. doi: 
10.3389/fimmu.2016.00105.
    (2) Carlsten M and Childs RW (2015) Genetic manipulation of NK 
cells for cancer immunotherapy: techniques and clinical implications. 
Front. Immunol. 6:266. doi: 10.3389/fimmu.2015.00266.
    Intellectual Property: NIH Reference No. E-036-2015/0,1--US 
Application No. 62/079,975, filed 14 Nov 2014; and PCT Application No. 
PCT/US2015/060646, filed 13 Nov 2015.
    Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301-
435-4507; [email protected].

    Dated: May 4, 2017.
Cristina Thalhammer-Reyero,
Senior Licensing and Patenting Manager, Office of Technology Transfer 
and Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2017-09791 Filed 5-15-17; 8:45 am]
BILLING CODE 4140-01-P

Federal Register / Vol. 82, No. 93 / Tuesday, May 16, 2017 / Notices 22553

Health, 6701 Rockledge Drive, Room 6194, MSC 2479, Bethesda, MD 20892–2479; Based Genetic Engineering of Human
MSC 7804, Bethesda, MD 20892, 301–594– telephone: 301–402–5579. A signed NK Cells with High-Affinity CD16 and
7945, smileyja@csr.nih.gov. Confidential Disclosure Agreement may CCR7 Augments Rituximab-Induced
Name of Committee: Musculoskeletal, Oral be required to receive any unpublished ADCC against Lymphoma and Targets
and Skin Sciences Integrated Review Group; information. NK Cell Migration toward the Lymph
Arthritis, Connective Tissue and Skin Study Node-Associated Chemokine CCL19.
SUPPLEMENTARY INFORMATION: The
Section.
Date: June 12–13, 2017. following inventions are available for Front. Immunol. 7:105. doi: 10.3389/
Time: 8:00 a.m. to 5:00 p.m. licensing in accordance with 35 U.S.C. fimmu.2016.00105.
Agenda: To review and evaluate grant 209 and 37 CFR part 404 to achieve (2) Carlsten M and Childs RW (2015)
applications. expeditious commercialization of Genetic manipulation of NK cells for
Place: Hilton Long Beach and Executive results of federally-funded research and cancer immunotherapy: techniques and
Center, 701 West Ocean Boulevard, Long development. Technology description clinical implications. Front. Immunol.
Beach, CA 90831. follows. 6:266. doi: 10.3389/fimmu.2015.00266.
Contact Person: Alexey Belkin, Ph.D., Intellectual Property: NIH Reference
Scientific Review Officer, Center for Efficient mRNA-Based Genetic No. E–036–2015/0,1—US Application
Scientific Review, National Institutes of Engineering of Human NK Cells With No. 62/079,975, filed 14 Nov 2014; and
Health, 6701 Rockledge Drive, Room 4102, High-Affinity CD16 and CCR7 PCT Application No. PCT/US2015/
Bethesda, MD 20817, 301–435–1786,
alexey.belkin@nih.gov.
Description of Technology: A highly 060646, filed 13 Nov 2015.
efficient method to genetically modify Licensing Contact: Cristina
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group;
natural killer (NK) cells to induce Thalhammer-Reyero, Ph.D., M.B.A.;
Clinical Research and Field Studies of expression of high affinity CD16 (HA– 301–435–4507; thalhamc@mail.nih.gov.
Infectious Diseases Study Section. CD16) through mRNA electroporation, Dated: May 4, 2017.
Date: June 12–13, 2017. to potentiate NK cell-mediated
Cristina Thalhammer-Reyero,
Time: 8:30 a.m. to 5:00 p.m. antibody-dependent cellular
Senior Licensing and Patenting Manager,
Agenda: To review and evaluate grant cytotoxicity (ADCC). ADCC is mediated
Office of Technology Transfer and
applications. by CD16+ NK cells following adoptive Development, National Heart, Lung, and
Place: Cambria Hotel and Suites, 1 Helen NK cell transfer, but most humans Blood Institute.
Heneghan Way, Rockville, MD 20850. express CD16 which has a relatively low
Contact Person: Soheyla Saadi, Ph.D., [FR Doc. 2017–09791 Filed 5–15–17; 8:45 am]
affinity for IgG1 antibodies. However, a
Scientific Review Officer, Center for BILLING CODE 4140–01–P
Scientific Review, National Institutes of
single nucleotide polymorphism (SNP
Health, 6701 Rockledge Drive, Room 3211, rs396991) in the CD16 gene, resulting in
MSC 7808, Bethesda, MD 20892, 301–435– an amino acid substitution at position DEPARTMENT OF HEALTH AND
0903, saadisoh@csr.nih.gov. 158 (F158V), is associated with HUMAN SERVICES
(Catalogue of Federal Domestic Assistance substantially higher affinity and
Program Nos. 93.306, Comparative Medicine; superior NK cell-mediated ADCC than National Institutes of Health
93.333, Clinical Research, 93.306, 93.333, those with the 158F genotype. This HA–
93.337, 93.393–93.396, 93.837–93.844, CD16–158V polymorphism has also National Institute on Minority Health
93.846–93.878, 93.892, 93.893, National been linked to enhanced ADCC capacity and Health Disparities; Notice of
Institutes of Health, HHS) in vivo. The nearly 100% efficiency of Closed Meeting
Dated: May 10, 2017. our method resulted in: (a) Sustained
surface expression of transgenes at high Pursuant to section 10(d) of the
David Clary, Federal Advisory Committee Act, as
Program Analyst, Office of Federal Advisory levels for up to 4 days without
compromising NK cell cytotoxicity and amended (5 U.S.C. App.), notice is
Committee Policy. hereby given of the following meeting.
[FR Doc. 2017–09780 Filed 5–15–17; 8:45 am] viability; and (b) augmented ADCC
The meeting will be closed to the
against Daratumumab coated multiple
BILLING CODE 4140–01–P public in accordance with the
myeloma cells by ex vivo expanded NK
provisions set forth in sections
cells electroporated with mRNA coding
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
DEPARTMENT OF HEALTH AND for HA–CD16. This system is GMP
as amended. The grant applications and
HUMAN SERVICES compliant and has been used previously
the discussions could disclose
in FDA approved clinical trials.
Potential Commercial Applications: confidential trade secrets or commercial
National Institutes of Health
Infusion of a large number of highly property such as patentable materials,
Government-Owned Invention; cytotoxic autologous ex vivo expanded and personal information concerning
Availability for Licensing NK cells expressing high-affinity CD16 individuals associated with the grant
into patients, to induce a more profound applications, the disclosure of which
AGENCY: National Institutes of Health, would constitute a clearly unwarranted
anti-malignancy response to specific
HHS. invasion of personal privacy.
monoclonal antibodies, including:
ACTION: Notice. multiple myeloma (Daratumumab); Name of Committee: National Institute on
lymphoma (Rituximab); breast cancer Minority Health and Health Disparities,
SUMMARY: The inventions listed below Special Emphasis Panel; NIH Support for
are owned by an agency of the U.S. (Trastuzumab); and colon cancer
Conferences and Scientific Meeting—DRI
Government. (Cetuximab).
(01).
sradovich on DSK3GMQ082PROD with NOTICES

Development Stage: Early-stage; In
FOR FURTHER INFORMATION CONTACT: Date: June 19, 2017.
vitro data available. Time: 8:00 a.m. to 5:00 p.m.
Licensing information may be obtained Inventors: Richard W. Childs and Agenda: To review and evaluate grant
by emailing the indicated licensing Mattias Carlsten (NHLBI). applications.
contact at the National Heart, Lung, and Publications: Place: National Institutes of Health,
Blood, Office of Technology Transfer (1) Carlsten M, Levy E, Karambelkar Gateway Plaza, 533J, 7201 Wisconsin
and Development Office of Technology A, Li L, Reger R, Berg M, Peshwa MV Avenue, Suite 533, Bethesda, MD 20814
Transfer, 31 Center Drive Room 4A29, and Childs RW (2016) Efficient mRNA- (Teleconference).

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Document Created: 2017-05-16 13:52:18
Document Modified: 2017-05-16 13:52:18

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive Room 4A29, MSC 2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information.
FR Citation		82 FR 22553

82 FR 22553 - Government-Owned Invention; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 93 (May 16, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health