[Federal Register Volume 85, Number 64 (Thursday, April 2, 2020)]
[Notices]
[Page 18579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06917]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: The Development 
of Bispecific Antibodies Targeting Glypican 1 (GPC1) for the Treatment 
of GPC1-Expressing Human Cancer

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 to NeoImmune Tech, 
Inc. (NeoImmune), located in Rockville, Maryland.

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 April 17, 2020 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: David Lambertson, Ph.D., Senior Technology 
Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center 
Drive, RM 3W610 MSC 9702, Bethesda, MD 20892-9702 (for business mail), 
Rockville, MD 20850-9702 Telephone: (240)-276-6467; Email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    U.S. Provisional Patent Application 62/795,415 entitled ``High 
Affinity Monoclonal Antibodies Targeting Glypican-1 For Treating 
Pancreatic Cancer'' [HHS Ref. E-028-2019-0-US-01], PCT Patent 
Application PCT/US2020/013739 entitled ``High Affinity Monoclonal 
Antibodies Targeting Glypican-1 For Treating Pancreatic Cancer'' [HHS 
Ref. E-028-2019-0-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 research, development and commercialization of a bispecific 
antibody having the following elements:
    (A) a first antibody component that binds to glypican 1 (GPC1), 
comprised of:
    (1) an antibody having the complementary determining region (CDR) 
sequences of the antibody known as HM2, or
    (2) an antibody having the CDR sequences of the antibody known as 
D4; and
    (B) a second antibody component that binds to CD3;
    For the treatment of GPC1-expressing human cancers.
    The Licensed Field of Use specifically excludes any unconjugated 
mono-specific therapeutic antibodies and non-specified 
immunoconjugates, including, but not limited to, chimeric antigen 
receptors (CARs) and variants thereof, recombinant immunotoxins, and 
antibody-drug conjugates (ADCs).
    This technology discloses antibodies that are specific for the cell 
surface domain of GPC1. GPC1 is a protein that is aberrantly expressed 
on several forms of cancer, including pancreatic cancer. The antibodies 
can be used either as unconjugated agents, or in the form of 
immunoconjugates (such as bispecific antibodies, CARs, ADCs and 
immunotoxins) to specifically target diseased cells that express GPC1, 
These agents can be used for the selective destruction of the diseased 
cells, resulting in treatment that may not have severe deleterious 
effects seen with less specific therapeutic modalities.
    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.
    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: March 24, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2020-06917 Filed 4-1-20; 8:45 am]
BILLING CODE 4140-01-P