Royalty Report: Drugs, Cancer, Disease – Collection: 284321

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 parties collaborated to globally develop and commercialize Licensor’s ladiratuzumab vedotin (MK-6440). The collaboration will pursue a broad joint development program evaluating ladiratuzumab vedotin as monotherapy and in combination with Keytruda (pembrolizumab) in triple-negative breast cancer, hormone receptor-positive breast cancer and other LIV-1-expressing solid tumors.

Licensor granted Licensee an exclusive license to commercialize Tukysa (tucatinib) for the treatment of HER2-positive cancers, in Asia, the Middle East and Latin America and other regions outside of the United States, Canada and Europe. Licensor will be responsible for marketing applications seeking approval in its territories, supported by the positive results from the HER2CLIMB clinical trial. Licensor will also co-fund a portion of the Tukysa global development plan, which encompasses several ongoing and planned trials across HER2-positive cancers, including breast, colorectal, gastric and other cancers set forth in a global product development plan.

License Property

Ladiratuzumab vedotin (MK-6440), an investigational antibody-drug conjugate targeting LIV-1, which is currently in Phase 2 clinical trials for breast cancer and other solid tumors.

Tukysa (tucatinib), a small molecule tyrosine kinase inhibitor to treat a type of breast cancer.

HER2-positive cancers is a protein that can promote the growth of breast cancer cells. Breast cancer cells with high levels of HER2 are called HER2-positive.

Licensor is a biotechnology company that study the subtlest biological mechanisms in search of therapies that will improve the lives of those who suffer from serious diseases including cancer.

Field of Use

The field of use is for the treatment of cancer such as breast cancer.

HER2-positive breast cancer is a type of breast cancer in which breast cancer cells have a protein receptor called HER2 (human epidermal growth factor receptor 2).

Licensee is a premier research-intensive biopharmaceutical company that researches medicines and vaccines to prevent and treat diseases including cancers.

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 parties agreed to collaboratively develop sitravatinib in Asia (excluding Japan and certain other countries), Australia and New Zealand (the Licensed Territory). Under this Agreement, Licensor granted Licensee an exclusive license to develop, manufacture and commercialize sitravatinib in the Licensed Territory, with Licensor retaining exclusive rights for the development, manufacturing and commercialization of sitravatinib outside the Licensed Territory.

License Property

Sitravatinib is an oral, spectrum-selective kinase inhibitor that potently inhibits specific receptor tyrosine kinases (“RTKs”). RTKs are families of kinases involved in the transmission of signals that regulate cell growth, survival, and migration and include TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. Sitravatinib addresses cancer via two distinct mechanisms directly, by targeting RTKs that drive tumor growth through mutation, and indirectly, by modulating immune regulatory cells to stimulate the body’s immune response to tumors. Sitravatinib’s potent inhibition of TAM and split family receptors may help overcome resistance to immune checkpoint inhibitors and stimulate the body’s immune response to help detect and destroy tumor cells. Blocking the signaling of these RTKs enhances the ability of T-cells (a type of white blood cell that is of key importance to the immune system) to recognize and eliminate tumor cells and modifies the tumor immune environment to enable a more productive immune response. The ability of sitravatinib to enhance the activity of immune checkpoint inhibitors was demonstrated in nonclinical cancer models.

Field of Use

This agreement pertains to the drug industry.

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.