Notice2025-12381
Prospective Grant of Exclusive, Inter-Institutional Agreement-Institution Lead: Generation of Antigen-Specific T and B Cells Using Engineered Commensals
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
July 2, 2025
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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, Inter- Institutional Agreement-Institution Lead to CZ Biohub SF, LLC ("CZB"), located in San Francisco, California, in its rights to the technologies and patent applications listed in the Supplementary Information section of this notice.
Full Text
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<title>Federal Register, Volume 90 Issue 125 (Wednesday, July 2, 2025)</title>
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[Federal Register Volume 90, Number 125 (Wednesday, July 2, 2025)]
[Notices]
[Pages 29028-29029]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12381]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive, Inter-Institutional Agreement-
Institution Lead: Generation of Antigen-Specific T and B Cells Using
Engineered Commensals
AGENCY: National Institutes of Health, National Institute of Allergy
and Infectious Diseases, 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, Inter-
Institutional Agreement-Institution Lead to CZ Biohub SF, LLC
(``CZB''), located in San Francisco, California, in its rights to the
technologies and 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 July 17, 2025 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated Exclusive, Inter-
Institutional Agreement-Institution Lead should be directed to:
Jonathan Motley, Ph.D., Technology Transfer and Patent Specialist,
Technology Transfer and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, 6D29,
MSC9804, Rockville, MD 20852-9804, phone number 240-669-5209, or
<a href="/cdn-cgi/l/email-protection#f59f9a9b94819d949bdb989a8199908cb59b9c9ddb929a83"><span class="__cf_email__" data-cfemail="d3b9bcbdb2a7bbb2bdfdbebca7bfb6aa93bdbabbfdb4bca5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The following and all continuing U.S.
patents/patent applications thereof are the intellectual properties to
be licensed under the prospective agreement to CZB: United States
Provisional Patent Application Serial No. 63/588,398, filed October 6,
2023, the title of which is ``Generation Of Antigen-Specific T And B
Cells Using Engineered Commensals'' (HHS Reference No. E-047-2024-0-US-
01); and PCT Application Number PCT/US24/50039, filed October 4, 2024
(HHS Reference No. E-047-2024-0-PC-01), the title of which is
``Generation Of Antigen-Specific T And B Cells Using Engineered
Commensals''.
The patent rights to this technology have been assigned to CZB, The
Board Of Trustees Of The Leland Stanford
[[Page 29029]]
Junior University, and the Government of the United States of America
as represented by the Secretary, Department of Health & Human Services.
The prospective patent license will be for the purpose of
consolidating the patent rights to CZB, for the development and
commercialization of the technology.
Consolidation of these co-owned rights is intended to expedite
development of the technology, consistent with the goals of the Bayh-
Dole Act codified as 35 U.S.C. 200-212.
The prospective interinstitutional agreement may include an
exclusive license for NIAID's rights in these jointly owned patents. It
will be sublicensable, and any sublicenses granted by CZB will be
subject to the provisions of 37 CFR part 404.
In the subject technology, the inventors describe a method of
modifying commensal bacteria to carry heterologous antigenic fragments
and the use of these modified bacterial cells to specifically stimulate
or reduce a host's immune response by modulating the response of T- and
B-cells or antigen-presenting cells (APCs). To modify the bacterial
cells, the inventors describe the use of genetic tools and fusion
proteins, transpeptidases, or by using covalent bonding of the
antigenic fragment to extracellular proteins found on the surface. The
modified bacteria are then applied to the skin or mucosal membranes of
a target mammal (including humans). Other applications could include
the delivery of molecules encased in lipid nanoparticles by adhering
them to the surface of the commensal bacteria via the modification
methods described above.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive license 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.
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.
Complete 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: June 30, 2025.
Surekha Vathyam,
Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2025-12381 Filed 7-1-25; 8:45 am]
BILLING CODE 4140-01-P
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