Prospective Grant of Exclusive Patent Commercialization License: CD28H Domain-Containing Chimeric Antigen Receptors and Methods of Use, 58681-58682 [2021-23092]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58681-58682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23092]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent Commercialization License: 
CD28H Domain-Containing Chimeric Antigen Receptors and Methods of Use

AGENCY: National Institutes of Health, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The National Institute of Allergy and Infectious Diseases, an 
institute of the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an exclusive patent 
license to Ankarys Therapeutics Inc., located at 110 Cumberland Street, 
Suite 520, M5R 3V5, Toronto, Ontario, Canada, to practice the 
inventions embodied in the patent applications listed in the 
Supplementary Information section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases on or 
before November 8, 2021 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated exclusive patent license 
should be directed to: Dawn Taylor-Mulneix, Technology Transfer and 
Patent Specialist, Technology Transfer and

[[Page 58682]]

Intellectual Property Office, National Institute of Allergy and 
Infectious Diseases, National Institutes of Health; phone number 301-
767-5189, or [email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement: PCT Patent 
Application Number PCT/US2020/024985, filed March 26, 2020, entitled 
``CD28H Domain-Containing Chimeric Antigen Receptors and Methods of 
Use'' (HHS Reference No. E-097-2020-00-PCT), and U.S. and foreign 
patent applications claiming priority to the aforementioned 
application.
    All rights in these inventions have been assigned to the Government 
of the United States of America.
    The prospective exclusive patent commercialization license 
territory may be worldwide, and the field of use may be limited to: 
``Use of natural killer cell immunotherapies for the treatment of 
multiple myeloma, non-Hodgkin lymphoma, and pancreatic cancer''.
    Engineered chimeric antigen receptors (CARs) that are expressed in 
cytotoxic T cells and natural killer (NK) cells have been used to 
specifically target tumor cells. However, CAR-T and CAR-NK cells are 
still subject to down regulation by their inhibitory receptors after 
injection into patients.
    Scientists at NIAID have developed CAR constructs that overcome 
inhibition of NK cells by receptors for human major histocompatibility 
complex molecules HLA-E and HLA-C, based on in vitro studies. The CAR 
contains an antigen binding domain of receptor CD28 homolog (CD28H), a 
CD28H transmembrane domain (TM), a CD28H signaling domain, and other 
intracellular signaling domains, such as 2B4 (CD244) and CD3 zeta chain 
(CD3zeta). A variant of this CAR, in which the antigen binding domain 
of CD28H is replaced by a single-chain antibody variable region (scFv) 
that binds to CD19, rendered NK cells resistant to inhibition by HLA-E 
and HLA-C on CD19+ tumor cells. An abstract for this invention was 
published in the Federal Register on April 22, 2020.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent commercialization license 
will be royalty bearing, and may be granted unless within fifteen (15) 
days from the date of this published notice, the National Institute of 
Allergy and Infectious Diseases 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.
    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent 
commercialization license. 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: October 19, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-23092 Filed 10-21-21; 8:45 am]
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