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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, HHS.

# ACTION:

Notice.

# 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 U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to Preverna, Inc. located in California, USA.

# 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 July 1, 2022 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: Suna Gulay French, Technology Transfer Manager, Telephone: (240) 276-7424; Email:                         *suna.gulay@nih.gov.*

# SUPPLEMENTARY INFORMATION:

## Intellectual Property

1. United States Provisional Patent Application No. 62/819,386, filed March 15, 2019 and entitled “Recombinant Molecules Containing Linker for Activation of T cells and Their Use in Immunotherapy” [HHS Ref. No. E-210-2018-0-US-01];

2. PCT Patent Application No. PCT/US2020/022752, filed March 13, 2020 and entitled “Chimeric Adaptor and Kinase Signaling Proteins and Their Use in Immunotherapy” [HHS Ref. No. E-210-2018-0-PCT-02];

3. European Patent Application No. 20718061.3, filed March 13, 2020 and entitled “Chimeric Adaptor and Kinase Signaling Proteins and Their Use in Immunotherapy” [HHS Ref. No. E-210-2018-0-EP-03];

4. Chinese Patent Application No. 202080021582.5, filed March 13, 2020 and entitled “Chimeric Adaptor and Kinase Signaling Proteins and Their Use in Immunotherapy” [HHS Ref. No. E-210-2018-0-CN-04];

5. Hong Kong Patent Application No. 62022051308.4, filed March 13, 2020 and entitled “Chimeric Adaptor and Kinase Signaling Proteins and Their Use in Immunotherapy” [HHS Ref. No. E-210-2018-0-HK-05]; and

6. United States Patent Application No. 17/475,810, filed September 15, 2021 and entitled “Chimeric Adaptor Proteins (CAPs) for Improved T-Cell Immunotherapy” [HHS Ref. No. E-210-2018-1-US-01].

(and U.S. and foreign patent applications claiming priority to the aforementioned applications).

The patent rights in these inventions have been assigned and/or exclusively licensed 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: “Development and commercialization of T cell and Natural Killer cell therapy products engineered by lentiviral transduction and/or lipid nanoparticle encapsulated mRNA transfection to express the Chimeric Adaptor Proteins claimed in the prospective licensed patent rights, for the treatment of solid tumors.”

This technology discloses Chimeric Adaptor Proteins (CAPs) for use in cancer immunotherapy. While similar to chimeric antigen receptors (CARs) in their content and mechanism of action, CAPs do not comprise a T cell receptor (TCR) domain and do not rely on TCR activation to stimulate the immune response. The inventors have instead found that adaptor molecules such as the linker for activation of T cells (LAT) are sufficient to form a distinct signaling complex and cause full immune cell activation. The functional features of CAPs may provide an advantage in immunotherapy, particularly against solid tumors.

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.

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: June 10, 2022.

Richard U. Rodriguez,

Associate Director, Technology Transfer Center, National Cancer Institute.

[FR Doc. 2022-12954 Filed 6-15-22; 8:45 am]

BILLING CODE 4140-01-P