Royalty Report: Drugs, Cancer, Disease – Collection: 369281

License Grant

Licensor hereby grants to Licensee and its Affiliates, and Licensee and its Affiliates hereby accept, an exclusive (even as to Licensor), royalty-bearing right and license (with the right to grant sublicenses in accordance with the provisions of Agreement) under the Licensor Technology to research, Develop, have Developed, Manufacture, have Manufactured, use, import, Commercialize and have Commercialized the Compound and Licensed Products in and for the Field and Territory.

License Property

Patent Application titles Novel Heterocyclic Compounds as BRD4 Inhibitors.

The BET inhibitor program is from Jubilant a family of patents covering compounds that inhibit BRD4, a member of the BET (Bromodomain and Extra Terminal) domain for cancer treatment.

There is emerging preclinical data showing BET inhibitors may enhance the activity of immuno-oncology agents, such as anti-PD-1/PD-L1 antibodies, providing multiple opportunities for us to combine this novel mechanism within our portfolio.  Epigenetic targeted agents, especially BET inhibitors, have been an area of great interest of ours for some time and are particularly attractive to us because of their effects on c-Myc driven tumors, like aggressive GCB-subtype DLBCL, an area we have seen early activity with TGR-1202 and our proprietary combination referred to as TG-1303.

Field of Use

The sub-license agreement is to develop and commercialize Jubilant’s novel BET inhibitor program in the field of hematological malignancies.

Field means all prophylactic, palliative, therapeutic or diangnostic uses in humans or animals for the prevention, diagnosis and treatment of hematological malignancies, including, without limitation, all Leukemia’s, Lymphoma’s, Multipe Myeloma and Waldenstrom’s Macroglobulinemia.

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

The parties wish to collaborate in connection with the research, development and commercialization of Licensors HDAC Inhibitors.

The Licensor of Denmark grants a co-exclusive, solely with Licensor, license in the Field throughout the Territory under the Licensors Licensed Technology, Licensors Collaboration Technology, and Licensors interest in the Joint Collaboration Technology to conduct the Research Program and to make and use Collaboration Products in connection with the Research Program, each in accordance with the terms of this Agreement.

License Property

Licensor is a biotechnology company with a development program, a library of compounds, and other intellectual property rights relating to HDAC Inhibitors.  HDAC Inhibitor shall mean a small molecule that inhibits the activity of histone deacetylase.

The patents cover Carbamic acid compounds comprising an ether linkage as HDAC inhibitors – short name HDAC-B (Ethers);  an amide linkage as HDAC inhibitors – short name HDAC-E (Amides) ;  a sulfonamide linkage as HDAC inhibitors – short name HDAC-F (Sulfonamides);  an ester or ketone linkage as HDAC inhibitors – short name HDAC-H (Ketones/Esters);  a piperazine linkage as HDAC inhibitors – short name HDAC-1 (Piperazines); and a bicyclic heteroaryl group as HDAC inhibitors – short name HDAC-J (Quinoxalines).

PXD101 is a novel histone deacetylase (HDAC) inhibitor for the treatment of solid and hematological cancers. PXD101 is currently in a Phase I clinical trial in patients with advanced solid tumors and is one of the most advanced HDAC inhibitors in development. HDAC inhibitors are a new class of potential anti-cancer agents that have shown promise in preclinical and clinical studies.

Patent family 'Carbamic acid compounds comprising an amide linkage as HDAC inhibitors' – short name ' HDAC-E (Amides)'
USA 10/381794
USA 10/381791

Patent family 'Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors – short name 'HDAC-F (Sulfonamides) '
USA 60/297784
USA 60/308136
USA 10/381790

Field of Use

The Field shall mean the prevention, diagnosis, control or treatment of any human disease or condition by use of a Collaboration Product, either as a single agent or in combination with any other therapy.

License Grant

The parties partnered to jointly develop and commercialize three of Licensor’s early-stage investigational bispecific antibody product candidates and enter into a discovery research collaboration for future differentiated antibody therapeutics for cancer.

License Property

Epcoritamab (DuoBody-CD3xCD20) is a bispecific antibody created using Licensor’s proprietary DuoBody technology. Epcoritamab is designed to target CD3, which is expressed on T cells and is part of the T cell receptor signaling complex, and CD20, a clinically well validated therapeutic target. CD20 is expressed on a majority of B cell malignancies, including chronic lymphocytic leukemia (CLL), diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL) and mantle cell lymphoma (MCL). In a number of laboratory models, epcoritamab has shown highly effective killing of CD20+ tumors and induced potent tumor cell lysis across a panel of B cell tumor lines. Epcoritamab is currently evaluated in a Phase 1/2 study for multiple hematological B cell malignancies.

The companies will partner to develop Licensor’s next-generation bispecific antibody programs, epcoritamab (DuoBody®-CD3xCD20), DuoHexaBody®-CD37 and DuoBody-CD3x5T4. The collaboration combines Licensor’s world-class discovery and development engine and next-generation bispecific antibody therapeutic candidates with Licensee’s deep clinical expertise, innovative antibody-drug conjugate (ADC) platform and global commercial leadership in hematological cancers. Licensor’s DuoBody-CD3 technology engages and directs cytotoxic T cells selectively to tumors to elicit an immune response towards malignant tumor cells. Licensee’s ADC technology allows the delivery of a therapeutic toxin directly to cancer cells while sparing normal, healthy cells, providing for a more targeted, less toxic treatment approach.

Licensor is a biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Licensors technology base consists of validated and proprietary next generation antibody technologies – the DuoBody® platform for generation of bispecific antibodies, the HexaBody® platform, which creates effector function enhanced antibodies, the HexElect® platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody® platform, which enhances the potential potency of bispecific antibodies through hexamerization.

Field of Use

The field of use is for the treatment of cancer utilizing antibodies. Bispecific antibodies (also known as dual-targeting molecules) bind to two different epitopes, either on the same or on different targets. This may improve the antibodies’ specificity and efficacy in inactivating the disease target cells.

Licensee has a clinical expertise, innovative antibody-drug conjugate (ADC) platform and global commercial leadership in hematological cancers.

License Grant

Included with this license and collaboration agreement is a license grant upon voluntary termination.

With respect to the applicable Reversion Compounds being terminated, Licensor grants, effective upon such termination, an exclusive even us to Licensor. sub-licensable, worldwide license under the Licensor Reversion Technology to research, develop, import, use, make. have made, offer for sale and sell Reversion Compounds and Reversion Products including as part of a Licensee Combination Therapy in the Field in the Territory.

License Property

Licensors Reversion Technology means Licensor Technology that both was actually used or generated by Licensor or its Affiliates or Sublicensees with respect to the applicable Reversion Compound or Reversion Product, and is necessary to continue development, manufacture or commercialization without unreasonable delay of the applicable Reversion Compound or Reversion Product.

Reversion Compound means NLG919, any Next Generation Compound or any Subsequent Compound.

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

Next Generation Compound means any Compound other than NLG919 that is invented, by or on behalf of Licensee or its Affiliate, whether solely or jointly, as of the Effective Date or thereafter during the Restriction Period, whether or not pursuant to the Research Plan, that is invented or otherwise the subject of research or preclinical development conducted, by or on behalf of Licensor or its Affiliate or Sublicensee, but excluding the pRED Organization, whether solely or jointly, during the Next Gen Research Term, whether or not pursuant to the Research Plan, the composition of matter, manufacture or use of which is Covered by a Valid Claim of a Licensee Patent or Collaboration Patent; or that is an enantiomer, polymorph, salt form, base, acid, racemate, isomer, diastereomer, tautomer, solvate, hydrate, ester or Known Prodrug of a Compound described above.

Field of Use

Field means any use.

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

The Licensor, an Australian medical research institute wholly dedicated to the prevention and treatment of childhood cancer, hereby grants to Licensee an exclusive license under the Licensed Patents and the Know-How in the Territory and within the Licensed Field to (a) make, have made, develop, use, practice, import, export, distribute, market, promote, offer for sale, and sell the Licensed Products, (b) use and practice any method, process, or procedure within the Licensed Patents, and (c) otherwise use and exploit the Licensed Patents.

The Institute hereby grants to Licensor an exclusive option to exclusively license any and all Improvement Inventions and Non-Improvement Inventions (the Option).

License Property

Licensed Patent shall mean
U.S. Patent Application #61/392,296 – Small Molecules Inhibiting Oncoprotein MYC
U.S. Patent Application #61/423,832 – Small Molecules inhibiting Oncoprotein MYC

ANTIMYCON
· Drug summary MYC inhibitor.
· Indications Drugs for treatment of a broad range of solid tumors (breast, prostate, colon, non-small cell lung carcinoma, etc.) and hematological malignancies (various types of leukemia and lymphoma).
· Mechanism of action CBLC-M compounds were generated to selectively target and inactivate oncoproteins of the Myc family, which are frequently upregulated in tumor cells. Although Myc has long been recognized as a highly attractive target for anti-cancer treatment, there are no experimental
or approved drugs targeting this transcription factor. CBLC-M compounds target Myc family proteins with a high degree of specificity and cause their selective degradation. This mechanism of action is translated into both a direct tumor-suppressive effect and increased susceptibility of tumor cells to conventional chemotherapeutic drugs. Combining CBLC-M with such drugs as doxorubicin, 5FU, irinotecan and others within composite nanoparticles will result in improved anti-tumor effects due to precise targeted drug delivery that will concentrate the synergistic effects of the combined compounds on the tumor cells while reducing toxicity to normal cells.

Field of Use

The rights granted apply to the healthcare industry.  Licensed Field shall mean all fields of use.