Notice2021-17849
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
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 20, 2021
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 159 (Friday, August 20, 2021)</title>
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[Federal Register Volume 86, Number 159 (Friday, August 20, 2021)]
[Notices]
[Pages 46858-46859]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-17849]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
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
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 ADC Therapeutics
Ltd (ADCT), located in Lausanne, Switzerland.
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 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: <a href="/cdn-cgi/l/email-protection#7c1d1e0e150819195218141d103c121514521b130a"><span class="__cf_email__" data-cfemail="b0d1d2c2d9c4d5d59ed4d8d1dcf0ded9d89ed7dfc6">[email protected]</span></a>.
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
antibody-drug conjugate (ADC) having:
(1) The CDR sequences of the 40H3 monoclonal antibody
(2) a DNA-damaging or immunostimulant payload including, but not
limited to, pyrrolobenzodiazepines, camptothecins, ecteinascidins, TLR/
STING agonists,
for the treatment of EGFR-overexpressing 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.
[[Page 46859]]
License applications submitted in response to this Notice will be
presumed to contain business confidential information and any release
of information in 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 16, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2021-17849 Filed 8-19-21; 8:45 am]
BILLING CODE 4140-01-P
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