Notice2024-04441
Government-Owned Inventions; Availability for Licensing
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 4, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Full Text
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<title>Federal Register, Volume 89 Issue 43 (Monday, March 4, 2024)</title>
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[Federal Register Volume 89, Number 43 (Monday, March 4, 2024)]
[Notices]
[Pages 15596-15597]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-04441]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The invention listed below is owned by an agency of the U.S.
Government and is available for licensing to achieve expeditious
commercialization of results of federally-funded research and
development. Foreign patent applications are filed on selected
inventions to extend market coverage for companies and may also be
available for licensing.
FOR FURTHER INFORMATION CONTACT: Peter Tung at 240-669-5483 or
<a href="/cdn-cgi/l/email-protection#e9998c9d8c9bc79d9c878ea9878081c78e869f"><span class="__cf_email__" data-cfemail="3545504150471b41405b52755b5c5d1b525a43">[email protected]</span></a>. Licensing information may be obtained by
communicating with the Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD 20852: tel. 301-496-2644. A signed
Confidential Disclosure Agreement will be required to receive copies of
unpublished information related to the invention.
Licensing information and copies of the patent applications listed
below may be obtained by communicating with the Technology Transfer and
Intellectual Property Office, National Institute of Allergy and
Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852 by
contacting Peter Tung at 240-669-5483 or <a href="/cdn-cgi/l/email-protection#7202170617005c06071c15321c1b1a5c151d04"><span class="__cf_email__" data-cfemail="59293c2d3c2b772d2c373e19373031773e362f">[email protected]</span></a>. A signed
Confidential Disclosure Agreement will be required to receive copies of
unpublished patent applications related to the invention.
SUPPLEMENTARY INFORMATION: Technology description follows:
Enhanced Single-Component AMA1-RON2 Vaccine Candidates: A Breakthrough
in Malaria Immunization
Description of Technology
This technology focuses on the creation of single-component AMA1-
RON2 (Apical membrane antigen 1-rhoptry neck protein 2) vaccine
candidates. These candidates are based on a novel composition of matter
designed to elicit a more effective immune response against the malaria
parasite Plasmodium falciparum. The standout aspect of this technology
is the Structure-Based Design 1 (SBD1) immunogen, engineered through a
structure-based design that significantly enhances its ability to
produce potent, strain-transcending neutralizing antibodies. This
approach not only surpasses the efficacy of traditional AMA1-RON2
complexes and other insertion fusion designs but also boasts higher
thermal stability, indicating better preservation and longevity of the
vaccine. The technology's increased stability and efficiency in
production present an opportunity to lower vaccine
[[Page 15597]]
manufacturing costs and simplify logistics, especially in regions where
malaria is endemic. Additionally, the adaptability of these immunogens
for integration with nanoparticle platforms could further amplify their
immunogenicity, paving the way for more robust and lasting protection
against malaria. This innovation can potentially transform malaria
prevention and control, offering a more effective, stable, and cost-
efficient solution to a disease that continues to impact millions
worldwide.
This technology is available for licensing for commercial
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as
well as for further development and evaluation under a research
collaboration.
Potential Commercial Applications
<bullet> Stable single-component AMA1-RON2 immunogens hold promise
for improving malaria prevention and control efforts in endemic regions
around the world.
Competitive Advantages
<bullet> No blood-stage malaria vaccine has been approved. This
technology offers a competitive edge over other vaccine candidates in
development through its easily manufactured single-component AMA1-RON2
design that elicits a potent broadly neutralizing response that is
better than competing candidates.
Development Stage
<bullet> The efficacy of stable single-component AMA1-RON2
immunogens has been validated in rat and rabbit models. Following
identification of the most cost-effective platform for vaccine
production, the immunogens will be advanced for virulent parasite
challenge studies in Aotus monkeys and towards human trials.
Inventors: Niraj Tolia, Ph.D., Thayne Dickey, Ph.D., Palak Patel,
Ph.D., all of NIAID.
Publications: Patel, P. N. et. al., Structure-based design of a
strain transcending AMA1-RON2L malaria vaccine. Nat. Commun. 14, 5345
(2023).
Intellectual Property: HHS Reference No. E-096-2023-0-US-01US-01;
US Provisional Application No. 63/524,522, filed on June 30, 2023.
Licensing Contact: To license this technology, please contact Peter
Tung at 240-669-5483 or <a href="/cdn-cgi/l/email-protection#cabaafbeafb8e4bebfa4ad8aa4a3a2e4ada5bc"><span class="__cf_email__" data-cfemail="d2a2b7a6b7a0fca6a7bcb592bcbbbafcb5bda4">[email protected]</span></a>, and reference E-096-2023.
Collaborative Research Opportunity: The National Institute of
Allergy and Infectious Diseases is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize this technology. For collaboration
opportunities, please contact Peter Tung at 240-669-5483 or
<a href="/cdn-cgi/l/email-protection#e59580918097cb91908b82a58b8c8dcb828a93"><span class="__cf_email__" data-cfemail="cbbbaebfaeb9e5bfbea5ac8ba5a2a3e5aca4bd">[email protected]</span></a>.
Dated: February 27, 2024.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2024-04441 Filed 3-1-24; 8:45 am]
BILLING CODE 4140-01-P
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