[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36808-36809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16525]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: The Development of 
a Bispecific, Biparatopic Antibody-Drug Conjugate to GPC3 for the 
Treatment of Human Liver Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant of 
an Exclusive Patent License to Salubris Biotherapeutics, Inc. 
(Salubris), located in Gaithersburg, Maryland, 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 NCI Technology Transfer Center on or before August 
22, 2017 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: David A. Lambertson, Ph.D., Senior Licensing and 
Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center 
Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), 
Rockville, MD 20850-9702; Telephone: (240) 276-6467; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement: (A) U.S. 
Provisional Patent Application 61/654,232 entitled ``High-affinity 
Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-
2012/0-US-01], PCT Patent Application PCT/US2013/043633 entitled 
``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' 
[HHS Ref. E-136-2012/0-PCT-02], Chinese Patent Application 
201380039993.7 entitled ``High-affinity Monoclonal Antibodies To 
Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-CN-03], Japanese 
Patent Application 2015-515243 entitled ``High-affinity Monoclonal 
Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-JP-
04], South Korean Patent Application 10-2014-7037046 entitled ``High-
affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS 
Ref. E-136-2012/0-KR-05], Singapore Patent Application 11201407972R 
entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use 
Thereof'' [HHS Ref. E-136-2012/0-SG-06], and United States Patent 
9,409,994 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 
And Use Thereof'' [HHS Ref. E-136-2012/0-US-07], and all continuing 
U.S. and foreign patents/patent applications for the technology family; 
and (B) U.S. Provisional Patent Application 61/477,020 entitled ``Human 
Monoclonal Antibody Specific for Glypican-3 And Use Thereof'' [HHS Ref. 
E-130-2011/0-US-01], PCT Patent Application PCT/US2012/034186 entitled 
``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' 
[HHS Ref. E-130-2011/0-PCT-02], Chinese Patent 201280029201.3 entitled 
``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' 
[HHS Ref. E-130-2011/0-CN-03], European Patent 2699603 entitled ``Human 
Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS 
Ref. E-130-2011/0-EP-04], and validated in France [HHS Ref. E-130-2011/
0-FR-09], Germany [HHS Ref. E-130-2011/0-DE-08] and the United Kingdom 
[HHS Ref. E-130-2011/0-GB-10] and lodged in Hong Kong [HHS Ref. E-130-
2011/0-HK-11], United States Patent 9,206,257 entitled ``Human 
Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS 
Ref. E-130-2011/0-US-05], United States Patent 9,394,364, entitled 
``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' 
[HHS Ref. E-130-2011/0-US-06], European Patent Application 15188264.4 
entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use 
Thereof'' [HHS Ref. E-130-2011/0-EP-07], United States Patent 
Application 15/090,873 entitled ``Human Monoclonal Antibodies Specific 
for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-12], Chinese 
Patent Application 201610290837.3 entitled ``Human Monoclonal 
Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-
2011/0-CN-13], European Patent Application 16166924.7 entitled ``Human 
Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS 
Ref. E-130-2011/0-EP-14], and all continuing U.S. and foreign patents/
patent applications for the technology family, to Salubris. The patent 
rights in these inventions have been assigned to and/or exclusively 
licensed to the Government of the United States of America.
    With respect to persons who have an obligation to assign their 
right, title and interest to the Government of the United States of 
America, the patent rights in these inventions have been assigned to 
the Government of the United States of America.
    The prospective Exclusive Patent License territory may be worldwide 
for the following field of use:

    The development and commercialization of a bispecific, 
biparatopic antibody-drug conjugate (ADC) having:
    (1) The CDR sequences of both the hYP7 and HN3 anti-GPC3 
monoclonal antibodies; and
    (2) a microtubule inhibitor payload including, but not limited 
to, auristatin and mertansine;

for the treatment of human liver cancer. The licensed field of use 
excludes any (a) non-specified immunoconjugates, including, but not 
limited to, chimeric antigen receptors (CARs) and variants thereof, 
immunotoxins, ADCs with payloads that are not microtubule 
inhibitors, and monospecific versions of the aforementioned 
immunoconjugates, and (b) unconjugated antibodies.

    The present inventions to be licensed concern monoclonal antibodies 
that are specific for the cell surface domain of GPC3: HN3 and hYP7. 
These antibodies can potentially be used for the treatment of GPC3-
expressing cancers such as HCC. In the subject situation, the 
antibodies can be used in conjunction to target a toxic payload 
specifically to GPC3-expressing cells, leading to the selective 
destruction of the cancerous cells.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404.

[[Page 36809]]

The prospective Exclusive Patent License will be royalty bearing and 
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.
    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 License. 
Comments and objections submitted to this notice will not be made 
available for public inspection and, to the extent permitted by law, 
will not be released under the Freedom of Information Act, 5 U.S.C. 
552.

    Dated: July 25, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-16525 Filed 8-4-17; 8:45 am]
BILLING CODE 4140-01-P