Royalty Report: Drugs, Cancer, Antibody – Collection: 182116

License Grant

The parties entered an agreement for one of the Licensors programs.

License Property

This program is for MM-121 or Seribantumab. Seribantumab is an antibody-drug that targets ErbB3 that was developed using the Selexis SUREtechnology Platform.

Field of Use

Licensee is currently conducting a Phase 2 trial of seribantumab (MM-121) in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer whose disease has progressed following immunotherapy.

License Grant

With this agreement, the French Licensee will receive an exclusive worldwide license to develop, manufacture and commercialize MM-121. Licensor will retain potential co-promotion rights in the United States.

Licensor grants the French Licensee an exclusive right and license, with the right to grant sub licenses, under Licensed Technology and Licensed Patent Rights, including Licensors rights to Joint Technology and Joint Patent Rights, to research, have researched, develop, have developed, make, have made, use, offer for sale, sell, have sold, import and export Collaboration Compounds and Licensed Products in the Field in the Territory.

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

License Property

Licensor has rights to a monoclonal antibody, known as MM-121, with binding affinity to the ErbB3 protein.
MM-121 is a monoclonal antibody designed to block signaling of the ErbB3 receptor, a member of the epidermal growth factor (EGF) receptor family.  

The Collaboration Compound means MM121, or, any antibody fragment of MM-121, including any Fab, F(ab)2, Fv, and scFv fragments, or the primary molecular target of which is ErbB3.  ErbB3, also known as HER3, is a transmembrane receptor belonging to the epidermal growth factor (EGF) receptor family.

MM-121 is currently in Phase 1 clinical testing.

Licensed Technology means the Diagnostic Technology and the Therapeutic Technology.

Field of Use

Field means all human and veterinary fields of use, including therapeutic, prophylactic and diagnostic uses in all possible indications.

MM-121 a genetically engineered antibody designed to block a receptor on cells known as ErbB3. That’s thought to be an important new target for cancer drugs, because it’s a member of the epidermal growth factor receptor family of proteins, which are known to amplify cell proliferation that can give rise to out-of-control tumors.

The ErbB3 receptor is a novel target known to be a key mediator of signaling in the ErbB pathway (also known as the EGFR or HER pathway) – a signaling network that impacts a broad array of cancers. By targeting ErbB3, MM-121 is believed to have a broad application across cancer as both a monotherapy and in combination with other therapeutics.

License Grant

The Licensee has the exclusive right to develop, manufacture and commercialize Opdivo in all territories worldwide except Japan, South Korea and Taiwan (where the Licensor was responsible for all development and commercialization prior to the amendment). The alliance agreement was amended to provide for additional collaboration activities in Japan, South Korea and Taiwan pertaining to Opdivo and several other Licensee compounds including ipilimumab, lirilumab, urelumab and BMS-986016 (anti-LAG3). Both parties have the right and obligation to jointly develop and commercialize the compounds. The Licensee is responsible for supply of the product.

License Property

The agreement is to develop and commercialize Opdivo, an anti-PD-1 human monoclonal antibody being investigated as an anti-cancer treatment. Opdivo (nivolumab) is a fully human monoclonal antibody that binds to the programmed death receptor-1 (PD-1) on T and NKT cells. It is being investigated as an anticancer treatment. It is in Phase III trials (which commenced in 2012) in non-small cell lung cancer, renal cell cancer and melanoma.

Field of Use

The parties jointly own a patent covering Opdivo as a composition of matter that expires in 2027 in the U.S. (excluding potential patent term extension). In December 2014, the FDA approved Opdivo for unresectable (inoperable) or metastatic melanoma, and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor. Opdivo was also approved in Japan in July 2014 for the same indication. The FDA has granted Fast Track designation for Opdivo in three tumor types: non-small cell lung cancer, renal cell carcinoma and metastatic melanoma, and it is in the registrational process for melanoma and non-small cell lung cancer in the U.S. and Europe. The FDA granted Breakthrough Therapy designation for Hodgkin Lymphoma in 2014.

License Grant

The parties agreed to have the Company develop Licensor’s pan-HER inhibitor, ARRY-543 (which the Company refers to as ASLAN001 or varlitinib), for the treatment or prevention of any disease or condition in humans, without upfront payments. Under the license agreement, the Company agreed to fund and globally develop ASLAN001 through proof of concept, initially targeting patients with gastric cancer through a development program conducted in Asia. Upon achievement of proof of concept, the Company agreed to collaborate or out-license to third parties for the further phase 3 development and commercialization.

License Property

ARRY-543 is a novel, oral ErbB family inhibitor that, unlike approved ErbB inhibitors, targets all members of the ErbB family, including ErbB3, either directly or indirectly, and has potential advantages in treating tumors that signal through multiple ErbB family members.

Field of Use

ARRY-543 is currently entering Phase 2 development for solid tumors.

Licensee will fund and globally develop ARRY-543 through proof of concept, initially targeting patients with gastric cancer through a development program conducted in Asia.

License Grant

The German Licensor grants the Swiss Licensee a worldwide, exclusive, right and license, or sublicense, with the right to grant sublicenses, under the Licensed Technology to make, have made, use, offer for sale, sell, and import the Product in the Field in the Territory.

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

License Property

Licensor is developing a pharmaceutical product comprising a human antibody of IgG-1 subtype binding to EpCAM.

The patents include Novel Method for the Production of anti-human Antigen Receptors and Uses thereof, and, Anti-EpCAM Immunoglobulins.

Decatumumab (MT201) is a recombinant human monoclonal antibody with a binding specificity to epithelial cell adhesion molecule (Ep-CAM). Adecatumumab (MT201) is being evaluated in two European Phase 2 clinical trials, one in patients with prostate cancer, and one in patients with metastatic breast cancer.

Field of Use

The Field means the treatment of human diseases, disorders and conditions.

License Grant

This is a global collaboration covering two novel cancer programs:  XL 184, a small molecule inhibitor currently in Phase III development and its associated development program; and,  XL281, a small molecule inhibitor of RAF kinase currently in Phase I development and its associated development program.

Licensor grants a co-exclusive license under the Licensors Licensed Know-How to clinically develop, make, have made, use, sell, offer for sale and import Co-Developed Products in the U.S.

Licensor grants a co-exclusive license under the Licensors Licensed Patents to clinically develop, make, have made, use, sell, offer for sale and import Co-Developed Products in the U.S.

Licensor grants an exclusive, subject to Licensors right to conduct Licensor Clinical Trials and work under the Backup Programs pursuant to this Agreement, license under the Licensor Licensed Know-How to clinically develop, make, have made, use, sell, offer for sale and import:  Royalty-Bearing Products in the U.S.; and Products in the Royalty Territory.

Licensor grants an exclusive, subject to Licensors right to conduct Licensor Clinical Trials and work under the Backup Programs pursuant to this Agreement, license under the Licensor Licensed Patents to clinically develop, make, have made, use, sell, offer for sale and import:  Royalty-Bearing Products in the U.S.; and Products in the Royalty Territory.

Licensor will grant a non-exclusive license to use such Licensor Marks solely in connection with the Commercialization of the Products in the Territory, the Trademark License Agreement.

License Property

Trademark is EXELIXIS®

Product means any therapeutic or prophylactic product that contains or comprises a Collaboration Compound. The Collaboration Compounds means:  XL184; and  XL281.

XL184 means:  the small molecule compound with Licensor identifier 02977184; the small molecule compounds listed in the Letter Agreement; any Program Backups to 02977184; and any isomer, racemate, salt, solvate, hydrate, metabolite, conjugate, ester, or prodrug of the compound.

XL281 means: the small molecule compound with Licensor identifier 03832819;  the small molecule compounds listed in the Letter Agreement; any Program Backups to 03832819; and any isomer, racemate, salt, solvate, hydrate, metabolite, conjugate, ester, or prodrug of the compound.

XL184 provides a novel approach to the treatment of a variety of solid tumors where signaling through MET, VEGFR2 or RET plays an important role in dysregulated tumor growth and progression. XL184 has recently begun a Phase III clinical trials in medullary thyroid cancer, a disease in which RET mutations are found in a large proportion of patients. In addition, clinical trials to exploit the MET and VEGFR2 targeting of XL 184 are ongoing in patients with non-small cell lung cancer and glioblastoma. Preclinically, XL184 also exhibits inhibitory activity for .MET and VEGFR2 in a variety of breast, colon and brain tumor models.

XL28 l is a novel small molecule designed to selectively inhibit RAF kinase, which lies immediately downstream of RAS and is a key component of the RAS/RAF/MEK/ERK kinase signaling pathway. The RAS/RAF/MEK/ERK pathway plays a key role in the transmission of growth-promoting signals downstream of receptor tyrosine kinases. Dysregulation of this pathway plays a pivotal role in the progression of many human tumors, and inhibition of the pathway may be useful in the treatment of cancer. Phase I trials with this molecule are underway in order to select a dose and schedule for Phase II disease-directed trials.

Field of Use

The field of use is oncology in animals or humans.  XL 184 is currently in Phase III development for medullary thyroid cancer.  XL281 is currently in Phase I development for the treatment of patients with advanced solid tumor malignancies.