Royalty Report: Drugs, Cancer, Pharmaceuticals – Collection: 28146

License Grant

The Licensee desires to hire the Licensor to execute the Project. Subject to all terms of this Agreement, the Licensor grants the Licensee
a fee-bearing, terminable, indivisible, non-transferable, right and license, with the right to grant sublicenses, to use and consume the Deliverables solely as necessary to conduct studies within the Research Field; and a fee-bearing, royalty-bearing, terminable, indivisible, non-transferable, exclusive right and license, with the right to grant sublicenses, to sell Licensed Human Therapeutic Products in the Territory within the Exclusive Field.

License Property

Invention shall mean Licensor's invention related to methods and compositions for targeted delivery and co-targeted delivery of therapeutic agents. Licensor owns technology and patent rights in the field of antibody-drug conjugates.

The Licensor's antibody-drug conjugate platform technology is based on unique multivalent, cleavable linkers that allow drugs tethered to the antibody to be released intracellularly or extracellularly upon binding of the antibody to the target cell.  and the technology platform allows multiple drugs to be attached per targeting antibody, and to release the drugs in their original form without modification of the drug.

Field of Use

Development of Antibody-Drug conjugates for the treatment of triple negative  Breast Cancer and Multiple Myeloma/Secondard Osteoporosis.

License Grant

Licensor grants
–   a terminable, indivisible, non-transferable, right and license, with the right to grant sublicenses, to use and consume the Deliverables solely as necessary to conduct studies within the Research Field; and,
–   a terminable, indivisible, non-transferable, exclusive right and license, with the right to grant sublicenses, to sell Licensed Human Therapeutic Products in the Territory within the Exclusive Field. Licensor shall not assert any Licensor Patent Rights against Licensee or any permitted sublicensee so long as such parties exercise the rights in the preceding sentence as permitted.

License Property

The Licensor's antibody-drug conjugate platform technology is based on unique multivalent, cleavable linkers that allow drugs tethered to the antibody to be released intracellularly or extracellularly upon binding of the antibody to the target cell.  and the technology platform allows multiple drugs to be attached per targeting antibody, and to release the drugs in their original form without modification of the drug.

Licensor owns technology and patent rights in the field of antibody-drug conjugates.

Licensed Product shall mean an antibody-drug conjugate therapeutic product containing [FZD7 monoclonal antibody and either 2-(4-phenylcyclohexyl)-5-(l',l'-dimethylheptyl)-resorcinol (0-1663) or 2-((3,4-bis(benzyloxy)benzyl)amino)ethan-1-ol (XRK3 or XIE3-P62) or 0-1663 and Taxol], that if made, used, sold, offered for sale or imported by OXIS or its Affiliate absent the license granted hereunder would infringe a Valid Claim of the Licensed Patent Rights, or otherwise use or incorporate the Licensed Technology Know-How Rights. For convenience, the chemical structures and alternative names for [0-1663, XIE3-P62 and Taxol] Taxol or Placitaxel.

Licensed Human Therapeutic Product shall mean a Licensed Product that is synthesized for and
intended for in vivo therapeutic use in humans.

The patent is titled Methods and Compositions for targeted Therapies.

Field of Use

The Exclusive Field shall mean the use of Licensed Human Therapeutic Products for in vivo treatment of triple negative breast cancer or multiple myeloma/secondary osteoporosis in humans.

Under the terms of the agreement, the Licensor will develop three antibody-drug conjugates product candidates which contain the Licensee's lead drug candidates OXS-2175 and OXS-4235.

License Grant

This amendment details terms, clarifies transfers of technology and modifies the royalty.  The original agreement is exclusive.

License Property

The licensed property is regarding Licensors antibody-drug conjugate technology.

'ADCs utilize the targeting ability of monoclonal antibodies to deliver potent, cell-killing payloads to specific cells.  ADC technology employs synthetic, highly potent drugs that can be attached to antibodies through proprietary linker systems. The linkers are designed to be stable in the bloodstream but to release the drug payload under specific conditions once inside target cells, thereby sparing non-target cells many of the toxic effects of traditional chemotherapy.

Field of Use

The Field, described in the original agreement, means any and all Antibody targeting applications for human or animal use unless mutually agreed to by the Parties.

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

For the Compound and Product, the Licensor grants the Swiss Licensee an exclusive, sublicensable license in the Field in the Territory under Licensor Patent Rights, Licensor Know-How, Licensor Product Trademarks and Companion Diagnostic Trademarks to make, have made, use, offer to sell, sell, import and otherwise Develop and Commercialize Compound and Product.

Licensor grants to Licensee, to the extent Licensor is legally able to do so, a non-exclusive, sublicensable,  license in the Territory under such issued letters patent for Licensee to develop, make, have made, use, sell, offer for sale or import Compounds and Products in the Territory.

For the Covenants/Companion Diagnostic,  Licensor grants a non-exclusive license, with the right to grant sublicenses, under Licensor Patent Rights, Licensor Know-How, and Companion Diagnostic Trademarks to  market and promote the Companion Diagnostic in the Field in the Territory for use in connection with the Product and use the Companion Diagnostic in any way necessary or reasonably useful in order for Licensee to exercise the license granted by Licensor.

This agreement is to develop and commercialize a novel investigational therapeutic candidate vintafolide (EC145).

License Property

Vintafolide is a late-stage cancer drug candidate.

Vintafolide is a proprietary, injectable, conjugate consisting of folate (vitamin B9) linked to a potent vinca alkaloid chemotherapy agent, desacetylvinblastine monohydrazide (DAVLBH).

Etarfolatide is a folate-targeted molecular imaging agent that is being developed as a noninvasive method to identify tumors that over-express folate receptors.

Product(s) means any pharmaceutical or biological preparation.

Field of Use

Vintafolide is currently being evaluated in a Phase Ill clinical trial for platinum-resistant ovarian cancer, (PROCEED trial) and a Phase II trial for non-small cell lung cancer (NSCLC}; both studies are also using investigational companion diagnostic agent, etarfolatide (EC20).

Vintafolide is designed to preferentially target the chemotherapy agent to fast growing cancer cells that actively take up folate via the folate receptor. The folate receptor is expressed in a wide variety of cancers including ovarian, NSCLC, breast, colon and kidney.