National Institute of General Medical Sciences; Notice of Closed Meeting, 46858 [2021-17875]
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46858
Federal Register / Vol. 86, No. 159 / Friday, August 20, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Prospective Grant of an Exclusive
Patent License: The Development of an
Epidermal Growth Factor Receptor
Variant III (EGFRvIII) Antibody-Drug
Conjugate (ADC) for the Treatment of
EGFRvIII-Expressing Human 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.
Name of Committee: NIGMS Initial Review
Group Training and Workforce Development
Study Section–C; Review of MARC and U–
RISE T34 Applications.
Date: October 21–22, 2021.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892 (Video Meeting).
Contact Person: Lee Warren Slice, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institutes of General
Medical Sciences, National Institutes of
Health, 45 Center Drive, Room 3AN18A,
Bethesda, MD 20814, 301–435–0807,
slicelw@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives; 93.859,
Biomedical Research and Research Training,
National Institutes of Health, HHS)
khammond on DSKJM1Z7X2PROD with NOTICES
Dated: August 17, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–17875 Filed 8–19–21; 8:45 am]
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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 ADC Therapeutics
Ltd (ADCT), located in Lausanne,
Switzerland.
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 September 7, 2021 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
an Exclusive Patent License should be
directed to: Abritee Dhal, Ph.D.,
Technology Transfer Manager, NCI
Technology Transfer Center, Telephone:
(240) 276–6154; Email: abritee.dhal@
nih.gov.
DATES:
SUPPLEMENTARY INFORMATION:
Intellectual Property
U.S. Provisional Patent Application
62/869,956 entitled ‘‘Monoclonal
Antibodies that Bind EGFRvIII and
Their Use’’ [HHS Ref. E–103–2019–0–
US–01], PCT Patent Application PCT/
US2020/040544 entitled ‘‘Monoclonal
Antibodies that Bind EGFRvIII and
Their Use’’ [HHS Ref. E–103–2019–0–
PCT–02], and U.S. and foreign patent
applications claiming priority to the
aforementioned applications.
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 use, development, manufacturing
and commercialization of an antibodydrug conjugate (ADC) having:
(1) The CDR sequences of the 40H3
monoclonal antibody
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
(2) a DNA-damaging or
immunostimulant payload including,
but not limited to,
pyrrolobenzodiazepines, camptothecins,
ecteinascidins, TLR/STING agonists,
for the treatment of EGFRoverexpressing tumors including, but
not limited to glioblastoma, head and
neck cancer, non-small cell lung cancer
(NSCLC) and colorectal cancer. The
license field of use excludes any (a)
non-specified immunoconjugates,
including, but not limited to, chimeric
antigen receptors (CARs) and variants
thereof, ADCs with payloads that are not
DNA-damaging, and (b) unconjugated
antibodies.’’
Epidermal growth factor receptor
(EGFR) is a transmembrane receptor for
members of the epidermal growth factor
(EGF) family of extracellular protein
ligands. There is substantial evidence
that aberrant EGFR activity is involved
in the pathogenesis and progression of
various types of cancers including
glioblastoma multiforme (GBM).
Aberrant EGFR activity is frequently
associated with genetic alterations in
EGFR expression (such as gene
amplification) or activity (such as
activating mutations). A particularly
prominent activating mutation is caused
by the loss of exons 2–7 to produce
EGFR variant III (EGFRvIII). This
constitutively active variant of EGFR is
expressed in cancer cells only.
Currently, there for no effective therapy
for patients with GBM. The EGFRvIII
ADC can potentially be used for the
treatment of GBM and other EGFR
expressing cancers such as head and
neck cancer, NSCLC and colorectal
cancer, the ADCs can lead to the
selective destruction of the cancerous
cells. The development of a new
therapeutic targeting EGFR will benefit
public health by providing an effective
treatment for patients with GBM and
other solid tumors.
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.
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[Federal Register Volume 86, Number 159 (Friday, August 20, 2021)]
[Notices]
[Page 46858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17875]
[[Page 46858]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of General Medical Sciences; 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: NIGMS Initial Review Group Training and
Workforce Development Study Section-C; Review of MARC and U-RISE T34
Applications.
Date: October 21-22, 2021.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Natcher Building, 45
Center Drive, Bethesda, MD 20892 (Video Meeting).
Contact Person: Lee Warren Slice, Ph.D., Scientific Review
Officer, Office of Scientific Review, National Institutes of General
Medical Sciences, National Institutes of Health, 45 Center Drive,
Room 3AN18A, Bethesda, MD 20814, 301-435-0807, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.375,
Minority Biomedical Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology, Physiology, and
Biological Chemistry Research; 93.862, Genetics and Developmental
Biology Research; 93.88, Minority Access to Research Careers; 93.96,
Special Minority Initiatives; 93.859, Biomedical Research and
Research Training, National Institutes of Health, HHS)
Dated: August 17, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-17875 Filed 8-19-21; 8:45 am]
BILLING CODE 4140-01-P
