SUPPLEMENTARY INFORMATION:

Intellectual Property

1. United States Provisional Patent Application No. 63/185,805 filed May 7, 2021, entitled “T Cell Receptors Recognizing C135Y, R175H or M237I Mutation in P53” [HHS Reference No. E-101-2021-0-US-01];

2. PCT Application No. PCT/US2022/028066 filed May 6, 2022, entitled “T Cell Receptors Recognizing C135Y, R175H or M237I Mutation in P53” [HHS Reference No. E-101-2021-0-PCT-02];

3. Canadian Patent Application No. 3217263 filed October 30, 2023, entitled “T Cell Receptors Recognizing C135Y, R175H or M237I Mutation in P53” [HHS Reference No. E-101-2021-0-CA-03];

4. Japanese Patent Application No. 2023-568469 filed November 6, 2023, entitled “T Cell Receptors Recognizing C135Y, R175H or M237I Mutation in P53” [HHS Reference No. E-101-2021-0-JP-02];

5. United States Patent Application No. 18/289,596 filed November 6, 2023, entitled “T Cell Receptors Recognizing C135Y, R175H or M237I Mutation in P53” [HHS Reference No. E-101-2021-0-US-07];

6. European Patent Application No. 22726335.7 filed November 22, 2023, entitled “T Cell Receptors Recognizing C135Y, R175H or M237I Mutation in P53” [HHS Reference No. E-101-2021-0-EP-08];

7. South Korean Patent Application No. 10-2023-7041691 filed December 1, 2023, entitled “T Cell Receptors Recognizing C135Y, R175H or M237I Mutation in P53” [HHS Reference No. E-101-2021-0-KR-06]; ( printed page 24552)

8. Australian Patent Application No. 2022268998 filed December 5, 2023, entitled “T Cell Receptors Recognizing C135Y, R175H or M237I Mutation in P53” [HHS Reference No. E-101-2021-0-AU-04];

9. Chinese Patent Application No. 202280047288.0 filed January 1, 2024, entitled “T Cell Receptors Recognizing C135Y, R175H or M237I Mutation in P53” [HHS Reference No. E-101-2021-0-CN-05]; and

10. Hong Kong Patent Application No. 62024096322.8 filed September 3, 2024, entitled “T Cell Receptors Recognizing C135Y, R175H or M237I Mutation in P53” [HHS Reference No. E-101-2021-0-HK-01].

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:

“T Cell Receptor (TCR)-engineered T cell therapy products for the treatment of cancer in humans.”

E-101-2021 patent family is primarily directed to isolated TCRs reactive to certain mutated forms of tumor protein 53 (TP53 or P53), within the context of several human leukocyte antigens. P53 is the archetypal tumor suppressor gene and the most frequently mutated gene in cancer. Contemporary estimates suggest that >50% of all tumors carry mutations in P53. Because of its prevalence in cancer and its restricted expression to precancerous and cancerous cells, this antigen may be targeted on mutant P53-expressing tumors with minimal normal tissue toxicity.

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.