Prospective Grant of an Exclusive Patent License: Development and Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies, 43148-43149 [2019-17866]
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43148
Federal Register / Vol. 84, No. 161 / Tuesday, August 20, 2019 / Notices
Terry Clark,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2019–17886 Filed 8–19–19; 8:45 am]
BILLING CODE 4150–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Potential Commercial Applications
• Target identification in B and T cell
deficiency, macrophage defects and
hematopoiesis.
• A tool for investigating IRF8
mediated issues associated with
inflammation and autoimmunity.
• Investigative tool for development
of potential therapeutics for lymphoma
and Human Chronic Myeloid Leukemia.
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
SUMMARY: The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Chris Kornak at 240–627–3705 or
Chris.Kornak@nih.gov. Licensing
information may be obtained by
communicating with the Technology
Transfer and Intellectual Property
Office, National Institute of Allergy and
Infectious Diseases, 5601 Fishers Lane,
Rockville, MD 20852; tel. 301–496–
2644. A signed Confidential Disclosure
Agreement will be required to receive
copies of unpublished information
related to the invention.
SUPPLEMENTARY INFORMATION:
Technology description follows:
jbell on DSK3GLQ082PROD with NOTICES
Floxed Targeted Mouse Strain for Use
in Conditional Deletion of the Irf8 Gene
Description of Technology
IRF8, a member of interferon
regulatory factor (IRF) family of
transcription factors is a novel intrinsic
transcriptional inhibitor of TH17-cell
differentiation. TH17-cells are believed
to be involved in the pathogenesis of
various autoimmune/inflammatory
diseases. The Irf8f floxed targeted
mutated mouse strain can be used to
selectively ablate expression of IRF8 in
any cell type in which a Cre
recombinase gene is activated. This will
permit the identification of IRF8regulated genes and their effects in
specific types of developing and mature
cells. These materials could be used to
help define patterns of gene expression
important for the development and
function of cells including possible
contributions to understanding: Normal
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immune responses, inflammatory
conditions, autoimmunity and anti-viral
responses.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Competitive Advantages
• Mice with established germ line
transmission for use in conditional
deletion of the IRF8 gene in any cell
type.
Development Stage
• Research Use.
Inventors: Herbert Carpenter Morse III
(NIAID).
Publications: Ouyang, Xinshou, et al.
‘‘Transcription factor IRF8 directs a
silencing programme for TH17 cell
differentiation.’’ Nature
Communications 2, Article number: 314
(2011).
Licensing Contact: To license this
technology, please contact Chris Kornak
at 240–627–3705 or Chris.Kornak@
nih.gov, and reference E–062–2012–0.
Dated: August 6, 2019.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2019–17868 Filed 8–19–19; 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 CD19/CD22
Chimeric Antigen Receptor (CAR)
Therapies for the Treatment of B-Cell
Malignancies
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
PO 00000
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Fmt 4703
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Patents and Patent Applications listed
in the Supplementary Information
section of this Notice to Lyell
Immunopharma, Inc. (‘‘Lyell’’), located
in South San Francisco, CA.
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 September 19, 2019 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:
jim.knabb@nih.gov.
SUPPLEMENTARY INFORMATION:
Intellectual Property
E–016–2015: Chimeric Antigen Receptor
Targeting both CD19 and CD22
1. U.S. Provisional Patent Application
62/135,442, filed March 19, 2015 (E–
106–2015–0–US–01);
2. International Patent Application
PCT/US2016/023055, filed March 18,
2016 (E–106–2015/0–PCT–02)
3. U.S. Patent Application No.: 15/
559,485, filed September 19, 2017 (E–
E–106–2015/0–US–03)
E–017–2017: CD19/CD22 Bicistronic
CAR Targeting Human B-Cell
Malignancies
1. U.S. Provisional Patent Application
62/506,268, filed May 15, 2017 (E–017–
2017–0–US–01);
2. International Patent Application
PCT/US2018/032,809, filed May 15,
2018 (E–017–2017/0–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:
An exclusive license to: ‘‘Treatment of B
cell malignancies using autologously-derived
T cell expressing chimeric antigen receptor(s)
(CAR) specific for both CD19 and CD22
utilizing the anti-CD19 antigen binding
domain of the FM63 antibody and the antiCD22 antigen binding domain of the M971
antibody.’’ The proposed territory is
worldwide.
This technology discloses CAR
therapies that target both CD19 and
CD22 by utilizing the anti-CD19 binder
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Federal Register / Vol. 84, No. 161 / Tuesday, August 20, 2019 / Notices
known as FM63 and the anti-CD22
binder known as M971. CD19 and CD22
are each expressed on the surface of B
cells in B cell malignancies and are
hallmark examples of antigen targeting
in CAR–T therapies, with CD19targeting CAR–T therapies being the
first FDA approved CAR–T, and CD22targeting CAR–T showing early promise
in clinical trials for ALL and NHL.
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 thirty (30) 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: August 6, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2019–17866 Filed 8–19–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
jbell on DSK3GLQ082PROD with NOTICES
ACTION:
Notice.
SUMMARY: The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
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20:49 Aug 19, 2019
Jkt 247001
FOR FURTHER INFORMATION CONTACT:
Vince Contreras, Ph.D., 240–669–2823;
vince.contreras@nih.gov. Licensing
information and copies of the U.S.
patent application listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD, 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Recombinant Nipah F Proteins and
Their Use
Description of Technology
Nipah virus is an emerging
pathogenic paramyxovirus responsible
for sporadic and isolated outbreaks of
severe respiratory and neurologic
disease in Southern Asia. As a zoonotic
virus, disease can manifest in both
animals and human with indigenous
fruit bats acting as natural reservoirs of
the virus. The effects of viral infection
vary from acute respiratory distress to
fatal encephalitis. There are currently
no approved therapeutics or vaccines
against the virus, and growing concerns
that this highly pathogenic infection has
the potential to cause larger epidemics
capable of inflicting significant
mortality burden.
Like the RSV fusion (F) glycoprotein,
the Nipah fusion glycoprotein is a target
of neutralizing antibodies that mediate
protection against infection. Previous
studies of prefusion-stabilized F
glycoproteins from pneumoviruses and
other paramyxoviruses (e.g. RSV and
PIVs) have shown they elicit higher
titers of neutralizing antibodies in both
animals and humans than post-fusion F
proteins.
Researchers at the Vaccine Research
Center (VRC) of the National Institute of
Allergy and Infectious Diseases (NIAID)
designed disulfide, cavity-filling and
other mutations that stabilize the Nipah
F glycoprotein in the prefusion
conformation and bind prefusionspecific antibodies. These mutations
also increase protein expression yields
up to 50-fold making the recombinant
proteins easy to manufacture and
amenable to the use of genetic
immunization using nucleic acid or
vector-based applications.
The stabilized prefusion state of the
Nipah F glycoprotein may be an ideal
vaccine immunogen to elicit broad
potent Nipah neutralizing antibodies.
First and second generation prefusion
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43149
molecules have been designed and
tested in small animals and results
(immunogenicity and stability) appear
promising.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Potential Commercial Applications
• Vaccine—to elicit potent
neutralizing antibodies against the
Nipah Env glycoprotein.
Competitive Advantages
Nipah prefusion F design has the
following features compared to wildtype fusion glycoprotein:
• Robust stabilization.
• Up to 50-fold increase in expression
yields, making the recombinant proteins
easy to manufacture.
• Potential to link the recombinant
glycoprotein to nanoparticles or
oligomerization peptides.
Development Stage: In vivo testing
(rodents).
Inventors: Barney S. Graham (NIAID),
Rebecca J. Loomis (NIAID), Guillaume
Stewart-Jones (NIAID), John R. Mascola
(NIAID), and Jason McLellan (NIAID).
Intellectual Property: HHS Reference
Number E–050–2018 includes U.S.
Provisional Patent Application Number
62/714,230 filed 08/03/2018.
Related Intellectual Property: PCT
Application No. PCT/US2008/087719
filed 19/12/2008.
Licensing Contact: Vince Contreras,
Ph.D., 240–669–2823; vince.contreras@
nih.gov.
Dated: August 7, 2019.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2019–17867 Filed 8–19–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Amended Notice
of Meeting
Notice is hereby given of a time and
room change in the meeting of the
HEAL (Helping to End Addiction Longterm) Multi-Disciplinary Working
Group, August 21, 2019, 08:30 a.m., to
August 22, 2019, 03:45 p.m., Building 1,
Wilson Hall, 1 Center Drive, Bethesda,
MD 20892 which was published in the
Federal Register on July 23, 2019,
84FR35402.
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Agencies
[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Pages 43148-43149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17866]
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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 CD19/CD22 Chimeric Antigen Receptor (CAR)
Therapies for the Treatment of B-Cell Malignancies
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 Lyell
Immunopharma, Inc. (``Lyell''), located in South San Francisco, CA.
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 September 19, 2019 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:
Intellectual Property
E-016-2015: Chimeric Antigen Receptor Targeting both CD19 and CD22
1. U.S. Provisional Patent Application 62/135,442, filed March 19,
2015 (E-106-2015-0-US-01);
2. International Patent Application PCT/US2016/023055, filed March
18, 2016 (E-106-2015/0-PCT-02)
3. U.S. Patent Application No.: 15/559,485, filed September 19,
2017 (E- E-106-2015/0-US-03)
E-017-2017: CD19/CD22 Bicistronic CAR Targeting Human B-Cell
Malignancies
1. U.S. Provisional Patent Application 62/506,268, filed May 15,
2017 (E-017-2017-0-US-01);
2. International Patent Application PCT/US2018/032,809, filed May
15, 2018 (E-017-2017/0-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:
An exclusive license to: ``Treatment of B cell malignancies
using autologously-derived T cell expressing chimeric antigen
receptor(s) (CAR) specific for both CD19 and CD22 utilizing the
anti-CD19 antigen binding domain of the FM63 antibody and the anti-
CD22 antigen binding domain of the M971 antibody.'' The proposed
territory is worldwide.
This technology discloses CAR therapies that target both CD19 and
CD22 by utilizing the anti-CD19 binder
[[Page 43149]]
known as FM63 and the anti-CD22 binder known as M971. CD19 and CD22 are
each expressed on the surface of B cells in B cell malignancies and are
hallmark examples of antigen targeting in CAR-T therapies, with CD19-
targeting CAR-T therapies being the first FDA approved CAR-T, and CD22-
targeting CAR-T showing early promise in clinical trials for ALL and
NHL.
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
thirty (30) 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: August 6, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2019-17866 Filed 8-19-19; 8:45 am]
BILLING CODE 4140-01-P