Notice2023-04411
Prospective Grant of an Exclusive Patent License: The Development of a CD276 Antibody-Drug Conjugate (ADC) for the Treatment of Solid Tumors
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 3, 2023
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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 BrickBio, Inc. ("BrickBio") located in Woburn, Massachusetts.
Full Text
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<title>Federal Register, Volume 88 Issue 42 (Friday, March 3, 2023)</title>
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[Federal Register Volume 88, Number 42 (Friday, March 3, 2023)]
[Notices]
[Pages 13450-13451]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-04411]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: The Development
of a CD276 Antibody-Drug Conjugate (ADC) for the Treatment of Solid
Tumors
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 BrickBio, Inc.
(``BrickBio'') located in Woburn, Massachusetts.
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 March 20, 2023 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: Rose M. Freel, Ph.D., Senior Licensing and
Patenting Manager, Telephone: (301) 624-8775; Email:
<a href="/cdn-cgi/l/email-protection#5a2835293f743c283f3f361a343332743d352c"><span class="__cf_email__" data-cfemail="05776a76602b6377606069456b6c6d2b626a73">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Intellectual Property
United States Provisional Patent Application No. 62/051,650, filed
September 17, 2014 and entitled ``Anti-CD276 Polypeptides and
Proteins'' [HHS Reference No. E-250-2014-0-US-01]; PCT Patent
Application PCT/US2015/050365, filed September 16, 2015 and entitled
``Anti-CD276 Polypeptides and Proteins'' [HHS Reference No. E-250-2014-
0-PCT-02]; Canadian Patent Application No. 2961609, filed September 16,
2015 and entitled ``Anti-CD276 Polypeptides and Proteins'' [HHS
Reference No. E-250-2014-0-CA-03]; United States Patent No. 10,604,582,
filed March 16, 2017 and entitled ``Anti-CD276 Polypeptides and
Proteins'' [HHS Reference No. E-250-2014-0-US-04]; Japanese Patent
[[Page 13451]]
No. 6613304, filed September 16, 2015 and entitled ``Anti-CD276
Polypeptides and Proteins'' [HHS Reference No. E-250-2014-0-JP-05];
Japanese Patent No. 6734227, filed May 25, 2017 and entitled ``Anti-
CD276 Polypeptides and Proteins'' [HHS Reference No. E-250-2014-JP-07];
European Patent No. 3193933, filed September 16, 2015 and entitled
``Anti-CD276 Polypeptides and Proteins'' [HHS Reference No. E-250-2014-
0-EP-06] and as validated in Germany, Spain, France, UK, and Italy; and
US Patent Application No. 16/812,980, filed March 9, 2020 [HHS
Reference No. E-250-2014-0-US-08]; and
United States Provisional Patent Application 62/947,135, filed
December 12, 2019, and entitled ``ANTIBODY-DRUG CONJUGATES SPECIFIC FOR
CD276 AND USES THEREOF'' [HHS Reference No. E-145-2019-0-US-01]; PCT
Application No. PCT/US2020/063732, filed December 8, 2020, and entitled
``ANTIBODY-DRUG CONJUGATES SPECIFIC FOR CD276 AND USES THEREOF'' [HHS
Reference No. E-145-2019-0-PCT-02]; Australian Application No.
2020402752, filed December 8, 2020, and entitled ``ANTIBODY-DRUG
CONJUGATES SPECIFIC FOR CD276 AND USES THEREOF'' [HHS Reference No. E-
145-2019-0-AU-03]; Canadian Application No. 3161573, filed December 8,
2020, and entitled ``ANTIBODY-DRUG CONJUGATES SPECIFIC FOR CD276 AND
USES THEREOF'' [HHS Reference No. E-145-2019-0-CA-04]; European
Application No. 20834060.4, filed December 8, 2020, and entitled
``ANTIBODY-DRUG CONJUGATES SPECIFIC FOR CD276 AND USES THEREOF'' [HHS
Reference No. E-145-2019-0-EP-05]; Japanese Application No. 2022-
535127, filed December 8, 2020 [HHS Reference No. E-145-2019-0-JP-06];
US Patent Application No. 17/783,171, filed June 7, 2022 [HHS Reference
No. E-145-2019-0-US-07]; and all U.S. and foreign patent applications
claiming priority to the aforementioned applications for each
technology.
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) with single
antigen specificity comprising:
(1) The CDR sequences of the m8524/m276 monoclonal antibody;
(2) a cleavable or non-cleavable linker; and
(3) a payload selected from the following categories:
pyrrolobenzodiazepine (PBD), maytansinoid, auristatin, camptothecian,
TLR agonist, STING agonist, cytokine or cytokine mimetic, targeted
protein degrader, or oligonucleotide; for the treatment of CD276-
expressing solid tumors.
The licensed field of use specifically excludes any (a) non-
specified immunoconjugates, including, but not limited to, chimeric
antigen receptors (CARs) and variants thereof, (b) unconjugated
antibodies, (c) bispecific antibodies, and (d) antibody-radioligand
conjugates.''
CD276, also known as B7-H3, is a cell surface tumor endothelial
marker that is highly expressed in the tumor vessels of human lung,
breast, colon, endometrial, renal, and ovarian cancer, but not in the
angiogenic vessels of healthy tissue. This differential expression
makes CD276 an attractive target for cancer treatment due to the
ability to selectively target pathological angiogenesis without
impacting physiological angiogenesis. The E-250-2014 technology
discloses antibodies that bind selectively to CD276 and other antibody-
based therapeutic formats such as antibody drug conjugates (ADCs). The
E-145-2019 technology discloses an ADC based on a modified version of
the m276/m8524 antibody that is disclosed under E-250-2014 that
incorporates mutations for site-directed conjugation and disruption of
Fc receptor binding.
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: February 27, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2023-04411 Filed 3-2-23; 8:45 am]
BILLING CODE 4140-01-P
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