[Federal Register Volume 88, Number 42 (Friday, March 3, 2023)]
[Notices]
[Pages 13450-13451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 
[email protected].

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