Prospective Grant of an Exclusive Patent License: In Vivo Manufactured Anti-CD19 Chimeric Antigen Receptor (CAR) Products for the Treatment or Prevention of B Cell Mediated Autoimmune Diseases
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 Lice...
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 Kyverna Therapeutics, Inc. (“Kyverna”), a company located in Emeryville, California, the United States of America.
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 2, 2026 will be considered.
ADDRESSES:
Inquiries and comments relating to the contemplated Exclusive Patent License should be directed to: Andrew Burke, Ph.D., Senior Technology Transfer Manager, NCI Technology Transfer Center, Telephone: (240)-276-5484; Email:
andy.burke@nih.gov.
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. U.S. Provisional Patent Application 62/006,313 (HHS Reference E-042-2014-0-US-01), filed 2 June 2014;
29. Indian Patent Application 202248047256 (HHS Reference E-042-2014-0-IN-35), filed 19 August 2022;
30. South Korean Patent Application 10-2024-7016401 (HHS Reference E-042-2014-0-KR-01), filed 17 May 2024;
31. Japanese Patent Application 2024-074954 (HHS Reference E-042-2014-0-JP-01), filed 2 May 2024;
32. Australian Patent Application 2024205043 (HHS Reference E-042-2014-0-AU-01), filed 24 July 2024;
33. European Patent Application 25209657.3 (HHS Reference E-042-2014-0-EP-01), filed 20 October 2025;
34. Israeli Patent Application 324883 (HHS Reference E-042-2014-0-IL-01), filed 24 November 2025; and
35. Japanese Patent Application 2025-283967 (HHS Reference E-042-2014-0-JP-02), filed 26 December 2025.
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:
“The development, production, and commercialization of an anti-CD19 targeting chimeric antigen receptor (CAR)-based immunotherapy using a:
1. non-viral synthetic nanoparticle-based system, or
2. viral system (excluding lentiviral)
that encapsulates mRNA or DNA encoding a CAR having the complementary determining region (CDR) sequences of the anti-CD19 scFv known as Hu19, for the treatment or prevention of autoimmune diseases.
The following are specifically excluded from the Licensed Field of Use:
1. Anti-CD19 targeting CAR-based immunotherapy using CRISPR/Cas9-edited allogeneic (where the donor and recipient are different) T lymphocytes.
2. Anti-CD19 targeting CAR-based immunotherapy using autologous T lymphocytes engineered by lentivirus.”
The E-042-2014-0 invention family generally discloses CARs which recognize the cell surface protein CD19. CD19 is expressed primarily on B cells, including autoreactive B cells which drive the development of certain autoimmune disorders. For many autoimmune diseases there are limited therapeutic options. The development of a new anti-CD19 CAR-based therapy has the potential to meet the needs of patients who are poorly served by existing standards of care.
It is noted that the exclusive field of use which may be granted to Kyverna applies to only a subset of CAR constructs claimed in the patent rights and does not include, for example, any constructs which exclusively utilize the FMC63-based antigen binding domain. Accordingly, the scope of rights which may be conveyed under the proposed license covers a portion of the possible applications of E-042-2014.
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: February 10, 2026.
Richard U. Rodriguez,
Supervisory Technology Transfer and Patent Specialist, Technology Transfer Center, National Cancer Institute.
Use this for formal legal and research references to the published document.
91 FR 6863
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Use this when citing the archival web version of the document.
“Prospective Grant of an Exclusive Patent License: In Vivo Manufactured Anti-CD19 Chimeric Antigen Receptor (CAR) Products for the Treatment or Prevention of B Cell Mediated Autoimmune Diseases,” thefederalregister.org (February 13, 2026), https://thefederalregister.org/documents/2026-02907/prospective-grant-of-an-exclusive-patent-license-in-vivo-manufactured-anti-cd19-chimeric-antigen-receptor-car-products-f.