2019-12707. Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for 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 Tailored Therapeutics, LLC. (“Tailored”), located in Potomac, MD.

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 2, 2019 will be considered.

ADDRESSES:

Requests for copies of the patent applications, 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, 9609 Medical Center Drive, RM 1E530, MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-9702; Telephone: [phone]; Facsimile: (240)-276-5504; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Intellectual Property

Group A

HLA-A3-Restricted T Cell Receptors Against Mutated RAS

1. U.S. Provisional Patent Application 62/749,750, filed October 24, 2018 (E-166-2018-0-US-01).

HLA Class II-Restricted T Cell Receptors Against RAS With G12R Mutation

1. U.S. Provisional Patent Application 62/795,203, filed January 22, 2019 (E-029-2019-0-US-01).

Group B

Methods of Producing T Cell Populations Using Hydroxycitric Acid and/or a Salt Thereof

1. U.S. Provisional Patent Application 62/661,941, filed April 24, 2018 (E-094-2018-0-US-01); and

2. International Patent Application PCT/US2019/028513, filed April 22, 2019 (E-094-2018-0-PCT-02).

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 fields of use may be limited to the following:

Fields of Use Applying to Intellectual Property Groups A and B

“Development, manufacture and commercialization of autologous, peripheral blood T cell therapy products engineered by CRISPR to express T cell receptors reactive to mutated KRAS, as claimed in the Licensed Patent Rights, for the treatment of human cancers. Specifically excluded from this field of use are retrovirally-engineered peripheral blood T cell therapy products for the treatment of human cancers.

Development, manufacture and commercialization of companion diagnostics approved or cleared by the FDA or equivalent foreign regulatory agency for Licensee-proprietary T cell therapy products.”

Fields of Use Applying to Intellectual Property Group B

“Development, manufacture and commercialization of autologous, peripheral blood T cell therapy products engineered by CRISPR to express T cell receptors reactive to mutated p53, as claimed in the Licensed Patent Rights, for the treatment of cancer in humans.

“Development, manufacture and commercialization of autologous, tumor infiltrating lymphocyte (TIL)-based adoptive T cell therapy products reactive to mutated p53, isolated as claimed in the Licensed Patent Rights, for the treatment of human cancers. Specifically excluded from this field of use are genetically engineered TIL cell therapy products for the treatment of human cancers.

Development, manufacture and commercialization of companion diagnostics approved or cleared by the FDA or equivalent foreign regulatory agency for Licensee-proprietary T cell therapy products.”

Intellectual Property Group A is primarily directed to isolated T cell receptors (TCRs) reactive to mutated Kirsten rat sarcoma viral oncogene homolog (KRAS), within the context of several human leukocyte antigens (HLAs). 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.

Intellectual Property Group B is primarily directed to methods of preparing isolated populations of T cells by culturing them in the presence of hydroxycitric acid and/or a salt thereof, and methods of treating cancer using populations of T cells cultured in such a manner.

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 which 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 from 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 3, 2019.

Richard U. Rodriguez,

Associate Director, Technology Transfer Center, National Cancer Institute.