Royalty Report: Drugs, Cancer, Delivery – Collection: 282010

License Grant

Licensee obtained the exclusive worldwide rights to develop, make, have made, use, sell, offer to sell, distribute, commercialize and import the technology related to the technology platform that uses peptides as a vehicle to deliver existing cytotoxic agents to sortilin receptors which are overexpressed on cancel cells.

License Property

The licensed technology consists in using peptides as a vehicle to specifically deliver existing cytotoxic agents, or other anti-cancer drugs, to sortilin receptors, which are overexpressed on cancer cells. The sortilin receptor is involved in the endocytosis process. This process involves a folding of the cell membrane (cell wall) to allow the internalisation of large particles. Once the anti- cancer drug attached to the peptide is directed to the sortilin receptor, the anti-cancer drug specifically enters the cancer cells, sparing non-cancerous cells. Cytotoxic drugs are known to have very potent anti-cancer activity; however, they cannot distinguish cancer cells from non-cancer cells and induce a number of adverse events. Therefore, the new anti-cancer technology licensed by Theratechnologies should allow for improved efficacy and safety of anti-cancer drugs.

Field of Use

This agreement pertains to the drug industry in the field of oncology.

License Grant

Licensor hereby grants to Japanese Licensee with respect to Licensor’s rights in and to the Licensed Technology, an exclusive sublicense, to the extent that such Licensed Technology is Controlled by Licensor with Licensor having obtained such Control, directly or indirectly, from a Third Party, and an exclusive license, to the extent that such Licensed Technology is Controlled by Licensor without Licensor having obtained such Control, directly or indirectly, from a Third Party, in each case within the Field of Use, and solely within the Territory, to research, develop, use, sell, offer for sale, promote and/or import IL13 and/or Products during the Term and the Additional Term. Such sublicense and license shall include rights to Licensee to designate its employees and the employees of its Affiliates to promote Products and to use Third Parties to inspect Products for receipt of shipment of Products.  Licensee acknowledges that the exclusive sublicense granted herein is subject to certain retained rights of the Licensors in some of the Licensed Patent Rights.

License Property

Intellectual property relating to IL13-PE38QQR, generically know as cintredekin besudotox.  Cintredekin besudotox is made from a human protein, Interleukin 13 (IL13), linked to a bacterial toxin, Pseudomonas exotoxin (PE). The IL13 portion binds to receptors on the tumor.

Licensor has determined that the key to making a useful tumor-targeting drug is the targeting mechanism that selects tumor cells while ignoring healthy ones. Cintredekin besudotox is a recombinant protein consisting of a single molecule composed of two parts a tumor-targeting molecule (interleukin-13) and a cytotoxic agent (Pseudomonas Exotoxin, or PE). IL13 receptors are found on malignant glioma cells, but not on healthy brain cells. The IL13 portion binds to receptors on the tumor like a key fits into a lock. The cancer cell latches onto and absorbs the IL13 and the attached PE, causing destruction of the cancer cell. Healthy brain cells appear to be unharmed because they do not have the IL13 receptors, and thus do not ingest the PE. IL13-PE38QQR has received orphan drug designation in Europe and the U.S., and fast track drug development program status from the U.S. Food and Drug Administration (FDA).

App. No. PCT/US00/31044 – Use of the Product in gene therapy applications to treat human cancers.
App. No. PCT/US01/25663 – Use of the Product in gene therapy applications to treat human cancers.

IL13 shall mean hIL13-PE38QQR and/or cphIL13-PE38QQR.

Product(s) shall mean any pharmaceutical product containing IL13 as the active component, in any formulation or dosage.

Licensed Technology shall mean any technology, know-how and other intellectual property (other than Trademarks) directed to IL13 and/or Products, formulations and/or methods Controlled on the Effective Date or to be Controlled during the Term and the Additional Term by Licensor or its Affiliates which are necessary or useful to research, Develop, use or Commercialize IL13 and/or the Product in the Territory in the Field of Use and shall include the Licensed Patent Rights and any Licensor Data.

Field of Use

IL13-PE38QQR generically knowns as cintredekin besudotox (sin' tre dek' in be soo' doe tox), which is a lead drug candidate for the treatment of glioblastoma multiforme (GBM).
Glioblastoma, also known as glioblastoma multiforme (GBM), is the most aggressive type of cancer that begins within the brain.

Field of Use shall mean, for each patent or application included in the Licensed Patent Rights listed hereto, the field of use designated below for such patent estate, and for any other Licensed Technology, the Field of Use shall mean the field of use for treating human cancer.

Licensed Fields of Use Use of the Licensed Product(s) and/or the Licensed Process(es) in gene therapy applications to treat human cancers. Specifically, transfection of cancer cells with the IL-13 Receptor-alpha-2 (IL-13Ra2) claim in order to sensitize such cells to the therapeutic effects of the IL-13 Receptor targeted immunoconjugates, hIL-13-PE38QQR or cphIL-13-PE38QQR, which were exclusively licensed to Licensee under DHHS exclusive patent license L-226-96/0.

License Grant

Licensor grants the exclusive, world-wide right and license to use and practice the Patent Rights, the Know-how, and any Improvements to develop, make, have made, use, sell, offer to sell, import, export, and lease Licensed Products in the Field and to perform Licensed Processes in the Field.

License Property

The patents are titled
L-Nucleoside Dimer Compounds and Therapeutic Uses;
Nucleoside Analogs and Uses Against Parasitic Infection;
Novel Nucleoside Analogs and Uses in Treating Plasmodium Falciparum; and,
Novel Nucleoside Analogs and Uses in Treating Diseases.

Licensor has certain Patent Rights and Know-how relating to a family of proprietary compounds capable of selectively delivering therapeutic drugs to diseased cells.

Field of Use

L-Nucleoside Conjugate (OVI-117)
Compounds evolving from Licensor’s L-nucleoside conjugate technology take advantage of cell membrane changes that differentiate cancerous cells from healthy cells. This anomalous characteristic of cancer cell membranes presents a unique opportunity for targeting these cells with new products which are uniquely designed cytotoxic nucleosides that selectively enter cancerous cells.