[Federal Register Volume 87, Number 105 (Wednesday, June 1, 2022)]
[Notices]
[Page 33176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11666]



[[Page 33176]]

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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 Anti-Mesothelin Chimeric Antigen Receptor (CAR) for the Treatment 
of Mesothelin-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 to Evotec 
International GmbH (Evotec), located in Hamburg, Germany.

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 June 16, 2022 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 A. Lambertson, Ph.D., Technology Transfer 
Manager, NCI Technology Transfer Center, Telephone: (240) 276-6467; 
Email: <a href="/cdn-cgi/l/email-protection#452124332c216b29242827203731362a2b052b2c2d6b222a33"><span class="__cf_email__" data-cfemail="640005120d004a08050906011610170b0a240a0d0c4a030b12">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Intellectual Property

    U.S. Provisional Patent Application 62/508,197 entitled ``Anti-
Mesothelin Polypeptides and Proteins'' [HHS Ref. E-106-2017-0-US-01], 
PCT Patent Application PCT/US2018/033236 entitled ``Anti-Mesothelin 
Polypeptides and Proteins'' [HHS Ref. E-106-2017-0-PCT-02], U.S. Patent 
Application 16/631,971 entitled ``Anti-Mesothelin Polypeptides and 
Proteins'' [HHS Ref. E-106-2017-0-US-03], U.S. Provisional Patent 
Application 63/290,761 entitled ``Anti-Mesothelin Polypeptides and 
Proteins'' [HHS Ref. E-033-2021-0-US-01], 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 license to be granted may be worldwide, and may be limited to 
the following field of use:

    ``The development, production and commercialization of a mono-, 
bi-, or multi-specific anti-MLSN (Mesothelin) chimeric antigen 
receptor (CAR)-based allogeneic immunotherapy using genetically 
engineered, iPSC-derived human NK cells where the CAR has at least:
    (1) The complementary determining region (CDR) sequences of the 
(humanized) anti-MSLN antibody known as 15B6;
    (2) A transmembrane domain; and
    (3) At least one signaling domain,
    for the treatment of MLSN-expressing solid tumors.''

    Mesothelin is a cell surface protein that is expressed on a number 
of types of cancer cells, including mesothelioma, pancreatic cancer, 
ovarian cancer, and certain lung cancers. There are currently few 
effective therapies for patients with these types of cancers, with many 
patients experiencing disease relapse. Upon relapse, there are even 
fewer second-line therapeutic options, underscoring an unmet patient 
need. The development of an anti-mesothelin CAR-based therapy can 
potentially be used for the treatment of mesothelin-expressing cancers. 
As a result, the development of a new therapeutic option targeting 
mesothelin will benefit public health by providing an effective 
treatment for patients that might otherwise have no options.
    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: May 25, 2022.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2022-11666 Filed 5-31-22; 8:45 am]
BILLING CODE 4140-01-P


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