CCX-354

December 27, 2016 By Mark Terry , BioSpace.com Breaking News Staff Swiss-based Vifor Pharma , part of the Galenica Group , announced an expansion of its development alliance with Mountain View, Calif.-based ChemoCentryx . In May 2016, Vifor licensed the rights to commercialize CCX168 (avacopan), a Complement 5a Receptor (C5aR) inhibitor for orphan and rare renal diseases in Europe, Canada, Mexico, Central and South America, and South Korea. At that time, they made a down payment of $85 million. In the new expansion, Vifor has paid $50 million upfront with various milestone payments and tiered double-digit royalties for CCX140, an orally-administered inhibitor of the chemokine receptor CCR2 for renal disease. The drug has completed a Phase II trial in diabetic kidney disease. The companies plan to focus on joint development of CCX140 in rare kidney diseases. Vifor will hold an option to solely develop and commercialize the compound in more common forms of chronic kidney disease. ChemoCentryx holds marketing rights for rare renal disease in the U.S. and China. Vifor holds rights for everything else. “Expanding our kidney health alliance with Vifor Pharma to include CCX140 is an important step in our vision to establish ChemoCentryx as a leader in new medicines for rare renal diseases,” said Thomas Schall , ChemoCentryx’s president and chief executive officer, in a statement. “We and Vifor Pharma believe that CCX140 has the potential to address life threatening renal diseases for which there are currently very limited treatment options. Building upon the extremely productive relationship with our partner so far, we very much look forward to expanding that relationship with this unique clinical asset.” CCX140 targets CCR2, which is found in some immune cells known as monocytes and macrophages. Blocking CCR2 is believed to cut inflammation stimulated by abnormal monocytes and macrophages, and has specific implications in renal diseases. “The expansion of our partnership with ChemoCentryx demonstrates Vifor Pharma’s commitment to remain at the forefront of new treatment for patients with renal diseases,” said Gianni Zampieri , Vifor’s chief executive officer, in a statement. “CCX140 is a highly innovative approach, which is implicated in a number of kidney diseases, including diabetic nephropathy. We look forward to working with ChemoCentryx to develop both CCX140 and the C5aR inhibitor avacopan as potential new treatment options for patients suffering from serious kidney diseases.” On November 7, ChemoCentryx announced it was making two presentations from its Phase II CLEAR and CLASSIC Phase II trials of CCX168 in patients with anti-neutrophil cytoplasmic auto-antibody (ANCA)–associated vasculitis (AAV). One was presented at the American Society of Nephrology (AN) Kidney Week 2016 and the other at the American College of Rheumatology (ACR) 2016 Annual meeting . “The positive results from the CLEAR and CLASSIC trials mark the successful culmination of our Phase II development program with avacopan in AAV,” said Schall in a statement at the time. “We believe the data show strongly that avacopan, via a novel mechanism for the treatment of AAV, provides rapid and effective control of the disease. Importantly, the data also show that avacopan eliminates the need for chronic high doses of steroids currently used in the standard of care. It follows that the robust datasets to be presented at these two upcoming medical meetings support our advancing avacopan into Phase III development, which we are now preparing to do.” In 2013, GlaxoSmithKline ended its partnership with ChemoCentryx for vecimon, a drug for Crohn’s disease. The drug failed the first of three Phase III trials. GSK also at that time decided not to work with the company’s anti-inflammatory program and returned another drug, CCX354.