2024-10970. Prospective Grant of an Exclusive Patent License: T Cell Receptor Fusion Proteins for the Treatment of Cancer

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 Patents and Patent Applications listed in the Supplementary Information section of this notice to INTcRON LLC (“INTcRON”) located in Memphis, Tennessee.

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 June 4, 2024 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: Andrew Burke, Ph.D., Senior Technology Transfer Manager, NCI Technology Transfer Center, Telephone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Intellectual Property

1. United States Provisional Patent Application No. 62/369,883 filed August 2, 2016, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-US-01];

2. PCT Patent Application No. PCT/US2017/044615 filed July 31, 2017, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-PCT-02];

3. Australian Patent No. 2017306038 issued October 5, 2023, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-AU-03];

4. Canadian Patent Application No. 3,032,870 effective filing date of July 31, 2017, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-CA-04];

5. Chinese Patent Application No. 201780059356.4 effective filing date of July 31, 2017, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-CN-05];

6. European Patent No. 3494133 issued July 6, 2022, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-EP-06];

a. Validated in the following jurisdictions: AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, HR, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM and TR.

7. Japanese Patent Application No. 2019-505220 effective filing date of July 31, 2017, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-JP-07];

8. United States Patent No. 10,611,816 issued April 7, 2020, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-US-08];

9. Israeli Patent No. 264425 issued August 2, 2023, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-IL-09];

10. South Korean Patent No. 10-2527052 issued April 25, 2023, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-KR-10];

11. Singapore Patent Application No. 11201900654Q effective filing date of July 31, 2017, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-SG-11];

12. Hong Kong Patent No. HK40009637 issued July 7, 2023, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-HK-12];

13. Hong Kong Patent Application No. 19132196.7 effective filing date of July 31, 2017, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-HK-13];

14. Singapore Patent Application No. 10201913959W filed December 31, 2019, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-SG-14];

15. United States Patent No. 11,208,456 issued December 28, 2021, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-US-15];

16. United States Patent No. 11,897,933 issued February 13, 2024, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-US-16];

17. United States Patent No. 11,840,561 issued December 12, 2023, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-US-17];

18. Japanese Patent No. 7413338 issued January 4, 2024, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-JP-18];

19. European Patent Application No. 22182473.3 filed July 1, 2022, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-EP-19];

20. Israeli Patent Application No. 301894 filed April 3, 2023, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-IL-01];

21. Hong Kong Patent Application No. 42023078137.9 filed August 28, 2023, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-HK-01];

22. Australian Patent Application No. 2023233125 filed September 21, 2023, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-AU-01];

23. Japanese Patent Application No. 2023-221526 filed December 27, 2023, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-JP-01];

24. United States Patent Application No. 18/423,020 filed January 25, 2024, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-US-02]; and

25. Chinese Patent Application No. 202410214235.4 filed February 27, 2024, entitled “Anti-KRAS G12D T Cell Receptors” [HHS Reference No. E-175-2016-0-CN-01].

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 the following:

“Development, manufacture and commercialization of acellular fusion protein therapy products for the treatment of cancer in humans, wherein:

1. The fusion protein contains at least the antigen binding domain of either T cell receptor (TCR) “TRAV12-2/TRBV10/2” or “TRAV4/TRBV5-6 (A, B or C)”, as disclosed and claimed in the Licensed Patent Rights;

2. The cancer expresses mutant KRAS G12D; and

3. The human(s) express(es) at least HLA-C*08:02 or HLA-C*05:01.

For the avoidance of doubt, specifically excluded from this Licensed Field of Use are cell therapy products ( e.g., T cell or natural killer cell-based) which have been genetically engineered to express the TCR(s) claimed in the Licensed Patent Rights.”

The Intellectual Property is primarily directed to isolated T cell receptors (TCRs) reactive to mutated Kirsten rat sarcoma viral oncogene homolog (KRAS), within the context of human leukocyte antigens (HLAs) C*08:02 or C*05:01. Mutated KRAS, which plays a well-defined driver role in oncogenesis, is expressed by a variety of human cancers, including pancreatic, lung, endometrial, ovarian and prostate. Due to its restricted expression in precancerous and cancerous cells, this antigen may be targeted on mutant KRAS-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.

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: May 15, 2024.

Richard U. Rodriguez,

Associate Director, Technology Transfer Center, National Cancer Institute.