Royalty Report: Drugs, Cancer, Biotechnology – Collection: 183924

License Grant

The Hong Kong based Licensor and Licensee of Sweden enter the amendment to the joint development agreement is for the global pivotal Phase III study in c-Met-driven PRCC. The original agreement is co-exclusive.

License Property

Savolitinib is an inhibitor of c-Met, an enzyme which has been shown to function abnormally in many types of solid tumors.  It is designed to be a potent and highly selective oral inhibitor, which through chemical structure modification addressed human metabolite-related renal toxicity, the primary issue that halted development on several other selective c-Met inhibitors.

Field of Use

Phase III clinical trial is related to developing savolitinib for papillary renal cell carcinoma.

License Grant

Licensor of Hong Kong grants to Licensee of Sweden, a co-exclusive license, with the right to sublicense  under the Licensor Technology and Licensor's interest in the Joint Technology, to Develop the Collaboration Compound and Collaboration Products in the Field in the Territory in accordance with the terms of this Agreement and an exclusive, even as to Licensor, license, with the right to sublicense, under the Licensor Technology and Licensor's interest in the Joint Technology, to Manufacture and Commercialize the Collaboration Products in the Field in the Territory.

For Licensee's Right of Reference. Licensor grants to Licensee and its Sublicensees a Right of Reference to all data included in the Regulatory Submissions and Regulatory Approvals Controlled by Licensor and its Affiliates relating to a Collaboration Compound or Collaboration Products to the extent necessary to obtain Regulatory Approval of any Collaboration Product in the Field in any country of the ROW Territory.

Each Party grants the other Party a worldwide, irrevocable, non-exclusive, perpetual, freely sublicensable right and license to exploit the Joint Technology in any manner without compensation.

License Property

Licensor owns or otherwise controls certain patents, patent applications, technology, know-how, scientific and technical information and other proprietary rights and information relating to the research, development and manufacture of the c-Met inhibitor known as HMPL-504.

The Agreement Compound means any compound with a molecular weight less than 1000 Da, other than a Collaboration Compound, that specifically targets the Collaboration Target and lacks material activity against other pharmaceutical targets (i.e. the IC50 value of such compound or product against another pharmaceutical target is more than thirty (30) times greater than the IC50 value of such compound or product against the Collaboration Target).

The Collaboration Compound means Licensor's proprietary compound designated by Licensor on the Effective Date as HMPL-504, with the generic name Volitinib, a novel targeted therapy and a highly selective inhibitor of the c-Met receptor tyrosine kinase for the treatment of cancer. Volitinib, which will imminently enter Phase I testing, has been discovered and developed in China.  Volitinib is a potent and highly selective c-Met inhibitor, which has been demonstrated to inhibit the growth of tumors in a series of pre-clinical disease models, especially for those tumors with aberrant c-Met signalling such as gene amplification or c-Met over-expression.

The key patent is Certain Triazolopyridines and Triazolopyrazines, Compositions Thereof and Methods of Use Therefor.

Savolitinib is a potential global first-in-class inhibitor of the mesenchymal epithelial transition factor, or c-Met, receptor tyrosine kinase, an enzyme which has been shown to function abnormally in many types of solid tumors. We developed savolitinib as a potent and highly selective oral inhibitor that was designed to address renal toxicity, the primary issue that has prevented all other selective c-Met inhibitors from gaining regulatory approval. In Phase I clinical studies, savolitinib has shown promising signs of clinical efficacy, causing tumor size reduction in patients with c-Met gene amplification in papillary renal cell carcinoma, non-small cell lung cancer, colorectal cancer and gastric cancer.

Field of Use

This agreement pertains to drugs for all diagnostic, prophylactic and therapeutic uses in the medical industry.

License Grant

The Chinese Licensor and Licensee collaborated on the sale for ORPATHYS® (savolitinib) in China.  Licensor is responsible for the clinical development, marketing authorization, manufacturing and supply of ORPATHYS® in China, while Licensee is responsible for its commercialization on China sales.

License Property

ORPATHYS® (savolitinib), an oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase.

ORPATHYS® is an oral, potent, and highly selective MET tyrosine kinase inhibitor (“TKI”) that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.

The Phase II trial is an open-label, two-cohort, multi-center study to evaluate the efficacy, safety and pharmacokinetics (“PK”) of ORPATHYS® in locally advanced or metastatic GC or GEJ patients whose disease progressed after at least one line of standard therapy.

Field of Use

Field of use is for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”).

License Grant

Licensor granted Licensee worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.

License Property

Capmatinib is a potent and highly selective MET inhibitor. The investigational compound has demonstrated inhibitory activity in cell-based biochemical and functional assays that measure MET signaling and MET dependent cell proliferation, survival and migration.
c-Met inhibitors are a class of small molecules that inhibit the enzymatic activity of the c-Met tyrosine kinase, the receptor of hepatocyte growth factor/scatter factor (HGF/SF). These inhibitors may have therapeutic application in the treatment of various types of cancers.

Field of Use

Capmatinib is being evaluated in patients with hepatocellular carcinoma, non-small cell lung cancer and other solid tumors, and may have potential utility as a combination agent.

License Grant

The parties entered into an exclusive license agreement to develop and commercialize lucitanib on a global basis, excluding China.

License Property

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 through 3 (FGFR1-3), vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3) and platelet-derived growth factor receptors alpha and beta (PDGFR α-ß).

Field of Use

A Phase I/IIa clinical trial of lucitanib was initiated in 2010 and has demonstrated multiple objective responses in FGFR1 gene-amplified breast cancer patients, and objective responses were also observed in patients with tumors often sensitive to VEGFR inhibitors, such as renal cell and thyroid cancer. FGFR amplification is common in a number of tumor types, including breast cancer and squamous non-small cell lung cancer, and we intend to study lucitanib in these cancers as well as other solid tumors exhibiting FGFR pathway activation.