Notice2026-05527
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 20, 2026
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the invention listed below, which 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 91 Issue 54 (Friday, March 20, 2026)</title>
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[Federal Register Volume 91, Number 54 (Friday, March 20, 2026)]
[Notices]
[Page 13606]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05527]
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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 National Institute of Allergy and Infectious Diseases
(NIAID), an institute of the National Institutes of Health (NIH),
Department of Health and Human Services (HHS), is giving notice of the
invention listed below, which 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: Inquiries related to this licensing
opportunity should be directed to: David Yang at 240-695-6406, or
<a href="/cdn-cgi/l/email-protection#5c183d2a353872053d323b1c32353d353872323534723b332a"><span class="__cf_email__" data-cfemail="387c594e515c166159565f78565159515c16565150165f574e">[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.
SUPPLEMENTARY INFORMATION: Technology description follows:
Gene Editing for ALPK1 p.Thr237Met
Description of Technology: ROSAH syndrome is a rare genetic disease
caused by a mutation in the human alpha kinase 1 (ALPK1) gene
(p.Thr237Met), leading to vision loss, swollen optic nerves, dry mouth,
enlarged spleen, and frequent headaches. Researchers in the Laboratory
of Clinical Immunology and Microbiology (LCIM) at the National
Institute of Allergy and Infectious Diseases (NIAID) have developed a
new approach that can precisely fix the ALPK1 mutation without causing
unwanted changes in the patient's DNA. This method uses a base editor
combined with a guide RNA to safely and efficiently convert the
pathogenic thymine of the mutation back to cytosine. In laboratory
tests, this gene editing technology successfully repaired the mutation
in patient-derived affected cells with high accuracy and no side
effects.
This therapy could be delivered directly to the eye or salivary
glands, or patient cells could be corrected outside the body and then
returned to the patient, offering hope for personalized treatment to
restore vision and improve quality of life for people with ROSAH
syndrome.
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> Personalized therapy for individuals with disease
secondary to the ALPK1 p.Thr237Met genetic variant.
Competitive Advantages:
<bullet> Highly accurate tool that directly repairs the faulty gene
that causes ROSAH syndrome, while avoiding unwanted changes elsewhere
in DNA.
<bullet> Corrects the mutation in most patient cells with few or no
mistakes.
<bullet> Can be delivered directly to affected areas (e.g., eye or
salivary glands) or can treat patient cells outside the body.
<bullet> Custom therapy for people with the ALPK1 mutation.
<bullet> Effective in cells that don't divide, unlike older gene
editing methods.
Development Stage:
<bullet> Pre-Clinical.
Inventors: Dr. Christina Torres Kozycki, Dr. Colin L. Sweeney, Dr.
Uimook Choi, all of NIAID.
Intellectual Property: HHS Reference No. E-044-2024-0. Provisional
Patent Application No. 63/733,836, filed on December 13, 2024, and PCT
Patent Application No. PCT/US2025/059432, filed on December 12, 2025.
Licensing Contact: To license this technology, please contact David
Yang at 240-695-6406, or <a href="/cdn-cgi/l/email-protection#6a2e0b1c030e44330b040d2a04030b030e44040302440d051c"><span class="__cf_email__" data-cfemail="5d193c2b343973043c333a1d33343c343973333435733a322b">[email protected]</span></a>, and reference E-044-
2024-0.
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. Area of specific interest
includes human clinical trials. For collaboration opportunities, please
contact David Yang at 240-695-6406, or <a href="/cdn-cgi/l/email-protection#175376617e73394e76797057797e767e7339797e7f39707861"><span class="__cf_email__" data-cfemail="662207100f02483f07080126080f070f0248080f0e48010910">[email protected]</span></a>.
Dated: March 18, 2026.
Surekha Vathyam,
Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2026-05527 Filed 3-19-26; 8:45 am]
BILLING CODE 4140-01-P
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