Royalty Report: Drugs, Cancer, Disease – Collection: 367301

License Grant

Licensor, nonprofit biomedical research center, grants the exclusive, world-wide license, with the right to grant sublicenses, to use and practice the Licensor Technology and the Patent Rights in all fields and to make, have made, use, sell, offer for sale, and/or import Licensed Product in all fields the License.

For the Exclusive Option to Future IDO Discoveries, Licensor grants the exclusive option to obtain an exclusive, worldwide, sublicensable license under Licensors interests in and to any or all Future IDO Discoveries, including any patent rights or other intellectual property covering or appurtenant to such Future IDO Discoveries, for any and all purposes, including to develop, make, have made, use, sell, offer for sale, and import products.

License Property

Licensor owns certain technology and intellectual property rights developed by its employees relating to inhibitors of lndoleamine 2, 3 Dioxygenase -2 (IDO-2), and related inventions.

The patent application is titled Indoleamine 2,3 Dioxygenase-2.

Expression of IDO has been described in a number of types of cancer, such as acute myeloid leukemia, ovarian cancer or colorectal cancer. IDO is part of the malignant transformation process and plays a key role in suppressing the anti-tumor immune response in the body, so inhibiting it could increase the effect of chemotherapy as well as other immunotherapeutic protocols.

Field of Use

IDO pathway inhibitors represent a key class of immune checkpoint inhibitors that are regarded as potential breakthrough approaches to cancer therapy.

License Grant

Licensor, nonprofit biomedical research center, grants the exclusive, world-wide license, with the right to grant sublicenses, under Licensors interest in the Licensor Technology and the Patent Rights, to use and practice the Licensor Technology and the Patent Rights in all fields and to make, have made, use, sell, offer for sale, and/or import Licensed Product in all fields.

License Property

Licensor owns certain technology and intellectual property rights relating to a family of phenylimidazoles for use as inhibitors of Indoleamine 2, 3 Dioxygenase (IDO).

The patent application is titled IDO INHIBITORS.

Field of Use

Licensee is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians.

License Grant

For the Development and Commercialization License, Licensor grants an exclusive license sublicenseable, under the Licensor Technology to research, make, have made and use Compounds in the Territory pursuant to the Next Gen Research Plan; to make or have made Licensed Compounds in the Territory for use in the manufacture of Licensed Products to develop, make, have made, use, sell, offer for sale, and import Licensed Products in the Field in the Territory; and, an exclusive license, sublicenseable, under the Licensor know-how to research Subsequent Compounds in the Territory, to make or have made Subsequent Compounds in the Territory for research use or for use in the manufacture of Subsequent Products and to develop, make, have made, use, sell, offer for sale, and import, Subsequent Products in the Field in the Territory; and,
an exclusive license, sublicenseable, under the Licensor know-how, solely after the end of the Restriction Period, to research, develop, make, have made, use, sell, offer for sale, and import Compounds in the Field in the Territory.

For the Research License, Licensor grants a perpetual, irrevocable, non-exclusive, non-sublicensable except to Third Party contractors and service providers performing for the benefit of Licensee,  license under the Licensor Technology and Licensee Technology to make, import, and use but not to sell or offer for sale Compounds for internal research purposes only.

Licensor grants an option to obtain an exclusive, sublicense from Licensor to certain Patent Rights licensed to Licensor under the Georgia Regents Research Institute License Agreement or Lankcnau Institute for Medical Research License Agreements, to research, develop, make, have made, use, sell, offer for sale and import Compounds and Licensed Products in the Field in certain countries in the Territory.

License Property

Licensor controls certain patents and know-how relating to its proprietary program regarding inhibitors of the IDO Target and TDO Target, including patents and know-hem covering the lead compound NLG919 and other compounds that are inhibitors of one or both targets.  IDO Target means indoleamine 2,3-dioxygenase 1.  TDO Target means tryptophan 2,3-dioxygenase.

Licensed Compound means NLG919 or any Next Generation Compound.

NLG919 means Licensor’s proprietary small molecule IDO inhibitor known as of the Execution Date as NLG919, as further described in IND 119045 or any enantiomer, polymorph, salt form, base, acid, racemate, isomer, diastereomer, tautomer, solvate, hydrate, ester or Known Prodrug thereof.

Compound means a compound with a molecular weight of two thousand (2,000) Daltons or less], that hinds to and inhibits the activity of one or both of the 100 Target and TDO Target. with an IC50 of 1 µMor less in the applicable Enzymatic Assay, and that is being researched, developed or commercialized to exert its influence through the inhibition of one or both of the IDO Target or TDO Target, including NLG919, but excluding Indoximod.

Enzymatic Assay means, with respect to the IDO Target, the assay described in IND 119045 Document PD0l-MRMP01 1-SP04-E248, and, with respect to the TDO Target. Enzymatic Assay shall also include an alternate means of detecting the products of the enzyme reactions or minor changes in the above enzyme assay protocols, as agreed upon by the JRC. Any IC50s of control compounds measured with an alternate assay format should fall within 3-fold of the assay method.

Indoximod means Licensor’s proprietary small molecule IDO pathway inhibitor known as of the Execution Date as indoximod, or 1-methyl-D-tryptophan, or any, enantiomer, polymorph, salt form, base, acid, racemate, isomer, diastereomer, tautomer, solvate, hydrate, ester or Known Prodrug thereof.

Field of Use

The agreement also calls for the Parties to engage in a research collaboration for the discovery of next generation IDO/TDO compounds, which represent potential breakthrough approaches to cancer therapy.

IDO pathway inhibitors are another class of immune check point inhibitors akin to the recently developed antibodies targeting CTLA-4, PD-1, and PD-L1 that represent potential breakthrough approaches to cancer therapy. The IDO pathway regulates immune response by suppressing T-cell activation which enables local tumor immune escape. Recent studies have demonstrated that the IDO pathway is active in many cancers, both within tumor cells as a direct defense against T-cell attack, and also within antigen presenting cells in tumor draining lymph nodes whereby this pathway promotes peripheral tolerance to tumor associated antigens (TAAs). When hijacked by developing cancers in this manner, the IDO pathway may facilitate the survival, growth, invasion and metastasis of malignant cells whose expression of TAAs might otherwise be recognized and attacked by the immune system. NewLink has a number of active programs directed at synthesizing inhibitors to the IDO pathway and additionally has discovered novel tryptophan-2,3-dioxygenase (TDO) specific inhibitors that are potential anti-cancer compounds which could function individually or in combination with IDO inhibition.

Indication means any separately defined. well-categorized class of human disease, syndrome or medical condition for which a separate MAA may be filed with a Regulatory Authority. Each different tumor type or a different hematological malignancy as classified by cell lineage (e.g., acute lymphoblastic leukemia is a different Indication from chronic myclogenous leukemia) shall be a separate Indication; however each different line of therapy for a particular tumor type or hematological malignancy will not he considered a separate Indication.

License Grant

This amendment changes the Licensee to Licensee or its Affiliate, compensation and other details.  The agreement includes patents relating to Tryptophan.

License Property

As of the March 28, 2006 the patents include
–  Regulation of T-Cell Mediated Immunity by Tryptophan
–  High Affinity Tryptophan Transporter
–  Antigen-Presenting Cell Populations and Their Use as Reagents for Enhancing of Reducing Immune Tolerance
–  Chemokine Receptor Antagonists as Therapeutic Agents
–  Regulation of T Cell-Mediated Immunity by D Isomers of Inhibitors of Indoleamine-2,3-Dioxygenase
–  Inhibitors of Indoleamine-2,3-Dioxygenase and Methods of Use
–  Regulation of T Cell-Mediated Immunity by D Isomers of Inhibitors of Indoleamine-2,3-Dioxygenase, and,
–  Use of Inhibitors of lndoleamine-2,3-Dioxygenase in Combination with Other Therapeutic Modalities

Field of Use

Licensee was formed for the purpose of developing treatments for cancer and other diseases.

License Grant

The University grants an exclusive right and license under the Licensed Patents and Licensed Technology to make, use, import, offer to sell and sell Licensed Products for the Field of Use in the Licensed Territory during the term of this Agreement.

License Property

The patents are for Regulation of T-Cell Mediated Immunity by Tryptophan;  High Affinity Try to ban Transporter;  Antigen-Presenting Cell Populations and Their Use as Reagents for Enhancing or Reducing Immune Tolerance;  Chemokine Receptor Antagonists as Therapeutic Agents; and,  Regulation of T Cell-Mediated Immunity by D Isomers of Inhibitors of Indoleamioe-2,3 -Dioxygenase.

Field of Use

The Field of Use means any and all medical applications, including without limitation, prevention, diagnostics, and therapy, including action as an adjuvant.