[Federal Register Volume 86, Number 159 (Friday, August 20, 2021)]
[Notices]
[Pages 46858-46859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17849]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: [email protected].

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