Notice2025-06878
Prospective Grant of an Exclusive Patent License: Size-Dependent Brain and Lymphatic Distribution of Macromolecular Drug Delivery Platform
Primary source
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Published
April 22, 2025
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 applications listed in the Supplementary Information section of this notice to Sangam Lifesciences, Inc. (Sangam), a company located in Denver, Colorado.
Full Text
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<title>Federal Register, Volume 90 Issue 76 (Tuesday, April 22, 2025)</title>
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[Federal Register Volume 90, Number 76 (Tuesday, April 22, 2025)]
[Notices]
[Pages 16878-16879]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06878]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Size-Dependent
Brain and Lymphatic Distribution of Macromolecular Drug Delivery
Platform
AGENCY: National Institutes of Health, Health and Human Services (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 applications listed in the
Supplementary Information section of this notice to Sangam
Lifesciences, Inc. (Sangam), a company located in Denver, Colorado.
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 April 22, 2025 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: Whitney Hastings, Ph.D., Senior Technology
Transfer Manager, NCI Technology Transfer Center, Telephone: (301)-624-
1286; Email: <a href="/cdn-cgi/l/email-protection#cbbca3a2bfa5aeb2e5a3aab8bfa2a5acb8f98ba5a2a3e5aca4bd"><span class="__cf_email__" data-cfemail="fa8d92938e949f83d4929b898e93949d89c8ba949392d49d958c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. US Provisional Patent Application No. 63/037,058 filed June 10,
2020, and entitled ``Size-Dependent Brain and Lymphatic Distribution of
Macromolecular Drug Delivery Platform'' [HHS Reference No. E-078-2020-
0-US-01];
2. US Patent Cooperation Treaty Application No. PCT/US2021/036548
filed June 9, 2021, and entitled ``Size-Dependent Brain and Lymphatic
Distribution of Macromolecular Drug Delivery Platform'' [HHS Reference
No. E-078-2020-0-PCT-02];
3. U.S. National Stage Application No. 18/009,710 filed December 9,
2022, and entitled ``Size-Dependent Brain and Lymphatic Distribution of
Macromolecular Drug Delivery Platform'' [HHS Reference No. E-078-2020-
0-US-06];
4. Australia National Stage Application No. 2021289443 filed
January 3, 2023, and entitled ``Size-Dependent Brain and Lymphatic
Distribution of Macromolecular Drug Delivery Platform'' [HHS Reference
No. E-078-2020-0-AU-03];
5. Canada National Stage Application No. 3186654 filed June 9,
2021, and entitled ``Size-Dependent Brain and Lymphatic Distribution of
Macromolecular Drug Delivery Platform'' [HHS Reference No. E-078-2020-
0-CA-04]; and
6. European Patent National Stage Application No. 21822452.5 filed
January 5, 2023, and entitled ``Size-Dependent Brain and Lymphatic
Distribution of Macromolecular Drug Delivery Platform'' [HHS Reference
No. E-078-2020-0-EP-05].
The patent rights in these inventions have been assigned 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 following:
``Use of the Patent Rights to develop, manufacture and
commercialize a poly (L-lysine succinylated) (PLS) alpha-
galactosylceramide prodrug for human and veterinary uses in the
treatment of cancer.''
This technology describes a drug delivery platform comprising a
negatively charged, synthetic polymer, PLS, which specifically targets
scavenger receptor A1 (SR-A1). The
[[Page 16879]]
PLS polymer contains side chains with pendant carboxylic acids that
facilitate conjugation of therapeutically active ingredients through
hydrolysable ester bonds, allowing for the delivery and controlled
release of drugs to SR-A1 expressing cells and tissues. Depending on
the nature of the therapeutic agent conjugated to the PLS, this drug
delivery platform has the potential to be widely applicable across a
range of psychiatric, oncology, infections, inflammatory and
neurological disorders. To date, this drug platform technology has been
tested with several therapeutic agents including alpha-
galactosylceramide, breflate, LD10, and HCQ.
The scope of exclusivity for this license will be limited to the
PLS-alpha-galactosylceramide prodrug for the treatment of cancers.
Other fields of use will still be available if this license is granted,
including use of the PLS-alpha-galactosylceramide prodrug for non-
oncology indications and the PLS platform conjugated to other
therapeutic agents.
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.
Complete applications for a license that are timely filed in
response to this notice will be treated as objections to the grant of
the contemplated exclusive patent license. 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: April 14, 2025.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2025-06878 Filed 4-21-25; 8:45 am]
BILLING CODE 4140-01-P
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</html>Indexed from Federal Register on April 22, 2025.
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