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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 10d 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 552bc4 and 552bc6, 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 SectionC; Review of MARC and U
RISE T34 Applications.
Date: October 2122, 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, 3014350807, 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. 202117875 Filed 81921; 8:45 am BILLING CODE 414001P

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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 Institutes 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 2766154; 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. E10320190
US01, PCT Patent Application PCT/
US2020/040544 entitled Monoclonal Antibodies that Bind EGFRvIII and Their Use HHS Ref. E10320190
PCT02, 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
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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 27 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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