Royalty Report: Drugs, Cancer, DNA – Collection: 237253

License Grant

Licensor grants an exclusive worldwide license under Licensor Technology solely in the Field, with the right to sublicense, to exercise its rights and carry out its obligations set forth in this Agreement; to develop, use, have used, manufacture, have manufactured, and import, the Compound, Bulk Drug Substance, and Drug Products in the Territory; to offer for sale, sell and import for sale Compound and Bulk Drug Substance, solely for purposes of incorporation into a Drug Product for sale, offer for sale, import and having sold pursuant to the terms of this Agreement; and to market, sell, have sold, import, and offer for sale, Drug Products in the Territory.

Licensor grants an exclusive worldwide license under the Licensor Technology, with no right to sublicense, to the extent useful to permit Licensee to use Biomarkers to monitor the effectiveness of the Compound in the Field, including in human subjects, solely in connection with research and/or development of Drug Products.  Licensor agrees that it shall negotiate in good faith with Licensee to reach agreement on a license to diagnostic products incorporating such Biomarkers for use solely in connection with the administration of the Drug Product in the Field. Licensor reserves all rights to Biomarkers and the use thereof for all purposes outside the Field.

This agreement also includes a non-exclusive grant back to Licensor.

License Property

Licensor has undertaken research and development relating to small molecule inhibitors of IMPDH, including VX-944.

The Compound shall mean VX-944 and  and any of its hydrates, salts, stereoisomers, polymorphs, prodrugs or metabolites.

IMPDH shall mean Inosine 5 -monophosphate dehydrogenase.

Drug Product shall mean any pharmaceutical preparation in finished dosage form containing the Compound for administration to human patients for any and all uses in the Field.

VX-944 is a small molecule, selective, uncompetitive novel inhibitor directed against human IMPDH enzyme. IMPDH inhibitors have been demonstrated to induce growth arrest, and extensively investigated as immunosuppressants. Here we show that VX-944 inhibits growth of human multiple myeloma (MM) cell lines, including those resistant to conventional agents, via induction of apoptosis and S phase arrest in vitro.

Field of Use

Field shall mean the administration or use of the Compound for the treatment or prevention of cancer in humans.

License Grant

Licensor grants to Licensee of the Russian Federation an exclusive right and license or  sublicense, as applicable, to the Licensed Technology to research, develop, make, have made, use, sell, offer for sale and import the Licensed Compound, Licensed Products and Licensed Product Biomarkers for the Field in the Licensee Territory.

This agreement includes a non-exclusive grant back to Licensor from Licensee.

License Property

Licensor develops, manufactures and commercializes products incorporating the proprietary compound known as tivozanib for the treatment of cancer.

Licensed Compound means the chemical compound 1-[2-chloro-4-(6,7-dimethoxyquinolin-4-yl)oxyphenyl]-3-(5-methyl-1,2-oxazol-3-yl)urea, otherwise known as tivozanib, and any and all pharmaceutically acceptable, acids, bases, esters, isomers, enantiomers, salts, stereoisomers, racemates, tautomers, polymorphs, complexes, chelates, crystalline and amorphous forms, prodrugs, solvates (including hydrates), metabolites and metabolic precursors, whether active or inactive, thereof.

Licensed patents are
Neuropilin-1 as a serum based biomarker;
Quinoline Derivatives and Quinazoline Derivatives having Azolyl Group; and,
Tivozanib Response Prediction.

Licensed Know-how is module 3 of the New Drug Application for tivozanib hydrochloride for the treatment of renal cell carcinoma.  

Licensed Product Biomarker means any and all biomarkers, including metabolite, DNA, RNA and protein profiles, discovered or developed by or on behalf of Licensor or Licensee during the Term that are for use with, including use in clinical testing of or use in any decision whether to prescribe, or relate to, are associated with or are correlated with patient populations who do or do not respond to treatment with, in the case of each, any one or more Licensed Products.

Tivozanib A potent, selective, long half-life vascular endothelial growth factor (“VEGF”) tyrosine kinase inhibitor (“TKI”) of VEGF receptors 1, 2 and 3. The Licensor is evaluating several potential paths for the development of tivozanib, including a second phase 3 trial of tivozanib in refractory renal cell carcinoma, or RCC.

Field of Use

The Field means the diagnosis, prevention and treatment of any disease or condition in humans other than non-oncologic diseases or conditions of the eye.

This agreement purpose is for the development, manufacturing and commercialization of Licensors small molecule vascular endothelial growth factor (YEGF) tyrosine kinase inhibitor tivozanib in the territories of Russia, Ukraine and the Commonwealth of Independent States (CIS), for all indications excluding ocular conditions.

License Grant

This agreement is to jointly develop and commercialize FLT3 kinase inhibitors in oncology and non-oncology indications.

Licensor grants an exclusive right and license under the Licensor Technology, Licensor Program Technology and Licensors interest in the Joint Program Technology, with a right to sublicense through multiple tiers of sublicenses, solely to Exploit Licensed Compounds and Products in the Field in the Territory.

This agreement includes a non-exclusive grant back to Licensor from Licensee.

License Property

Licensor is engaged in the research and development of small molecule compounds that inhibit human kinase enzymes, and it has identified a compound known as AC220 that may be useful in treating cancer, and Licensor has obtained or filed for patents with respect to AC220, and certain related compounds, and their use in human therapeutic applications.

Lead Product means the Product containing AC220 being developed by Licensor.

AC220 is a novel, orally available, potent and highly selective small molecule that was specifically designed as a second generation FMS-like tyrosine kinase-3 (FLT3) inhibitor using Licensors
proprietary drug discovery engine, KINOMEscanâ„¢.

Licensors Compound means AC220; AC886; or any salt, human metabolite, human prodrug, including ester prodrugs, free-base, hydrate, solvate, polymorph, isomer or enantiomer of AC220 or AC886.

Field of Use

Quizartinib is currently in Phase 2b clinical development in patients with relapsed/refractory acute myeloid leukemia, or AML, who express a genetic mutation in FLT3.