Royalty Report: Drugs, Cancer, Disease – Collection: 263763

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.

License Grant

Licensor, a University, grants an exclusive license under the Patents to make, to have made, use and sell Licensed Products in the Field of Use in the Territory.

License Property

The Licensed Products shall mean products falling within the scope of a Valid Claim or claims of the Patents or made by processes within the scope of a Valid Claim or claims of the Patents.  The patents are for the Method of Enhanced Transmembrane Transport of Exogenous Molecules.

Method of Enhanced Transmembrane Transport of Exogenous Molecules (continuation of P-88080 now abandoned) (biotin, riboflavin) (CIP of 07/331,816, 4/30/89 ABAN) Patent No. 5,108,921

Method of Enhanced Transmembrane Transport of Exogenous Molecules (folate) U.S. Patent No. 5,416,016

Method of Enhanced Transmembrane Transport of Exogenous Molecules (thiamin) U.S. Patent No. 5,635,382

Method for Targeting a Diagnostic Agent to Cells (no transmembrane transport required) U.S. Patent No. 5,820,847

Composition and Method for Tumor Imaging U.S. Patent No. 5,688,488

Folic Acid Derivatives U.S. Nationalized PCT filed 4/17/00

Method of Treatment Using Lignad-Immunogen Conjugates

Field of Use

The Field of Use shall mean All Diagnostic and Imaging Applications and All Therapeutic Applications.  The Licensee is developing targeted therapies for the treatment of cancer and inflammatory diseases.

License Grant

Licensor out-licensed our secondary LiPlaCis® and 2X-111 programs to Licensee of Norway for Phase 2 clinical development of each program together with its DRP® companion diagnostic. Licensor will support Licensee in these studies by providing DRP® companion diagnostic analysis for screened patients in each trial.

License Property

LiPlaCis® is an advanced, targeted liposomal formulation of Cisplatin, one of the world’s most widely used chemotherapies. The specific LiPlaCis® formulation utilizes a proprietary phospholipase A (sPLA2-IIA) cleavage substrate for controlled, selective hydrolyzation, disruption and release of drug payload in the presence of tumor cells. This delivery vehicle may result in drug accumulation directly at tumor site, thereby potentially increasing drug targeting at the tumor and reducing negative, off target drug effects and toxicity that is well known for cisplatin.

X-111 is an advanced, targeted liposomal formulation of Doxorubicin, one of the world’s most widely used chemotherapies. The specific 2X-111 formulation, which exploits a glutathione enhanced PEG-liposomal delivery system, it may allow 2X-111 to cross the blood-brain barrier (BBB), thereby potentially enabling the treatment of primary brain tumors, such as glioblastoma multiforme (GBM), and secondary brain tumors that originated from cancers outside the brain, such as metastatic breast cancer.

DRP® is a predictive biomarker platform to generate drug-specific companion diagnostics.  it is used as a companion diagnostics platform to advance therapeutic candidates by targeting and evaluating patient sub-populations having gene signatures, determined by the DRP® companion diagnostics platform, that will potentially correlate with drug efficacy and patient response to treatment.

Field of Use

Field of use is for the treatment of metastatic breast cancer (mBC) and advance 2X-111 for the treatment of glioblastoma multiforme (GBM) such as brain tumors.

License Grant

The agreement grants rights to Licensee to patents and intellectual property, solely to develop, manufacture, exploit, import, use, offer for sale and sell Licensed Product and Licensed Process into and throughout the Territory for research and development of Companion Diagnostics.

Also included is a grant back If this Licensor desires to develop, manufacture, exploit, import, use, offer for sale or sell any Companion Diagnostic on its own or with or through any Affiliate or Third Party, it will send written notice thereof to Licensee, and, if Licensee chooses not to develop, then Licensor shall be granted any associated rights to do so.

License Property

The licensed technology includes (I) Alternative Splicing Event (ASE) technology based on International Patent Application WO 2012/116248 A1 entitled 'Alternatively Spliced mRNA Isoforms as Prognostic and Therapeutic Tools for Metastatic Breast Cancer and Other Invasive/Metastatic Cancers'; and (ii) Technology and know-how stemming.

Companion Diagnostics means any diagnostic product or biomarker arising from work performed by Licensor pursuant to the terms of this Agreement or otherwise derived from or based in whole or in part on Licensees Intellectual Property.

Discovery Product means a pre-clinical Licensed Product identified through a Screening Assay which possesses desirable properties of a therapeutic or prophylactic agent for the treatment of a clinical condition based on in vitro studies.

Therapeutic Product means an agent with prophylactic or therapeutic activity for the prevention and/or treatment of cancer, developed, in whole or in part, from a Discovery Product and intended to be used, or is used, to treat cancer in humans.

Licensee Patent Rights include
– FGFR1/2 IIIc in NSCLC resistant to erlotinib.
– FGFRviii in glioblastoma.

MIT Patent Rights include
– Alternatively Spliced mRNA lsoforms as Prognostic Indicators for Metastatic Cancer.

Field of Use

Field means the use or intended use in treatment and/or prevention of cancer in humans, and shall include the use of any Licensed Product or Licensed Process in connection with the development of Companion Diagnostics.

Licensees therapeutic focus targets a critical metastatic pathway in solid tumors responsible for driving tumor resistance and the spread of aggressive cancer.

License Grant

University grants a worldwide, exclusive license under the Patent Rights to make and have made, to use and have used, and to offer to sell, sell or import, and have offered to sell, sold or imported, the Licensed Products in the Field of Use, and to practice and have practiced the Licensed Processes and Know-How.

University also grants the right to enter into sublicensing agreements under the Patent Rights.

License Property

The University rights are for the Method for Synthesizing Epothilones and Epothilone Analogs and any other U.S. application owned by the University that has Valid Claims covering the manufacture, use, or sale of [trans-9,10-dehydro-epothilon,D].

Epothilones inhibit cell division with a mechanism of action similar to taxanes, one of the most successful classes of anti-tumor agents.

KOS-1584 is our epothilone anticancer clinical candidate that is being evaluated in dose-escalating Phase 1 clinical trials in patients with solid tumors.

Field of Use

The Licensee is developing its epothilone, KOS-1584, in Phase 1 clinical trials and it has shown activity in patients with non-small cell lung, ovarian, breast, pancreatic, prostate and other cancers.

License Grant

The Parties entered into an exclusive commercial sub-license agreement, relating to the development and marketing of KRX-0403. The KRX-0403 license agreement provides for worldwide sublicense rights, with the exception of the Far East. Under the agreement, Licensee has assumed responsibility for the development and marketing of KRX-0403.

The Canadian Licensor grants to Licensee an exclusive sublicense, even as against the Licensor, under the Patent Rights to develop and have developed, market and have marketed, sell and have sold, distribute and have distributed, and manufacture and have manufactured, the Licensed Products in the Territory, said license to include the right to further sub-license.

License Property

Licensor is engaged in research and development related to the drug known as AVLB, including all of its forms.

Licensed Product shall mean anhydrovinblastine sulfate (AVLB), with the chemical name 3 ,4 – dehydrovinblastine sulphate and molecular formula C4Jls~40s-H2SO4•.

KRX-0403 is a novel spindle poison in the vinca alkaloid class of drugs. Derived from the periwinkle plant, the family of vinca alkaloids and the mechanistically similar family of taxanes include some of the most successful cancer drugs ever developed, including Navelbine®, Taxol® and Taxotere®. Although these agents have been widely prescribed, they can be very toxic and may cause varying degrees of neurotoxicity and/or bone marrow suppression. We believe that an equally or more effective but less toxic therapy would satisfy a substantial need for these patients. In a number of pre-clinical animal studies of human cancers, including non-small cell lung cancer, KRX-0403 demonstrated greater anti-cancer activity and lower toxicity than currently marketed vinca alkaloids. In a Phase I clinical trial designed to evaluate the safety, toxicity profile and pharmacokinetics of KRX-0403 in patients with different tumor types, including lung cancer, breast cancer, sarcoma and colon cancer, KRX-0403 was demonstrated to be safe in humans with reversible and manageable toxicities. We believe KRX-0403 may have utility in the treatment of breast, lung and other forms of cancer. We plan to conduct additional dosing clinical trials for KRX-0403.

Field of Use

The Licensee is a biopharmaceutical focused on the acquisition, development and commercialization of novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer.