GSK ends ChemoCentryx collaboration
This article was originally published in Scrip
ChemoCentryx said on 3 December that GlaxoSmithKline decided not to license CCX168 and returned the rights to CCX354, thereby ending the companies' seven-year-old drug development partnership.
Mountain View, California-based ChemoCentryx managed to gain 9.6% in after-hours trading to reach $5.50 per share after the company revealed the loss of its big pharma partner, possibly because ChemoCentryx buried the GSK collaboration update at the end of a press release announcing positive Phase II results for CCX168 in the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated renal vasculitis (AARV). The oral drug targets the chemo-attractant C5a receptor (C5aR).
GSK's decision to walk away from CCX168 and CCX354 (GSK2941266) follows the company's decision to return the rights to vercirnon (CCX282) in September (scripintelligence.com, 19 September 2013). GSK gave up on vercirnon after the inhibitor of the chemokine receptor known as CCR9 failed in a Phase III Crohn's disease study (scripintelligence.com, 26 August 2013).
ChemoCentryx is down 40% since the vercirnon failure in August and is trading at the low end of the stock's $4.57 to $14.96 range for the past year. The company's market cap is $215.2m.
But just as he did in September following GSK's vercirnon decision, ChemoCentryx president and CEO Thomas Schall put a positive spin on the end of the companies' collaboration, which gave ChemoCentryx $63.5m up front in 2006 plus up to $1.5bn in milestone fees for as many as six product development programs.
"CCX168 is a leading asset in our pipeline and along with CCX140, our CCR2 inhibitor in a Phase II trial for diabetic nephropathy, anchors the renal disease portfolio wholly-owned by the company," Dr Schall said.
Sagient Research's BioMedTracker gave CCX140 a 27% likelihood of US FDA approval, which is 3% below average for drugs in similar stages of development, when the CCR2 inhibitor failed to show statistical significance in Phase II results announced in September.
CCX168 met the main goal in a 26-patient Phase II clinical trial, which was reducing the amount of high-dose corticosteroids used to treat AARV patients.
"The major unmet needs in AARV treatment are improvements in safety, especially by reducing glucocorticoid exposure, and reducing the time taken to achieve disease control. These Phase II data show encouraging signs that treatment with CCX168 both enabled a reduction in glucocorticoid exposure and improved the speed and quality of remission," the study's principal investigator David Jayne said in a statement from ChemoCentryx. Dr Jayne is director of the Vasculitis and Lupus Clinic at Addenbrooke's Hospital in Cambridge, UK.
During a 3 December conference call with analysts and investors Dr Schall said CCX168 is now ChemoCentryx's lead drug candidate. The company will speak with the FDA during the first half of 2014 about a Phase III program for CCX168. ChemoCentryx also plans to seek orphan drug and breakthrough therapy designations for CCX168, which would speed up development and regulatory review for the AARV therapy.
As for its other programs, Dr Schall said ChemoCentryx will pursue development partners for vercirnon and other CCR9 inhibitors.
Chief business officer Markus Cappel said in the company's public statement that ChemoCentryx has identified more potent CCR1 inhibitors that will complement CCX354, which is a candidate to treat rheumatoid arthritis.