ChemoCentryx Announces Presentation of Data from Ongoing Phase Ib Clinical Trial of CCR2 Inhibitor C

ChemoCentryx, Inc., (Nasdaq:CCXI) today announced the presentation of results from its immuno-oncology program at the American Society of Clinical Oncology (ASCO) 2017 Gastrointestinal Cancers Symposium being held January 19-21, 2017 in San Francisco, California.

The presentation highlights results from a continuing open-label, single-arm Phase Ib clinical trial of CCX872 when added to standard of care FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan and oxaliplatin) in patients with advanced non-resectable pancreatic cancer. CCX872 is a selective inhibitor of the chemokine receptor known as CCR2.

The primary efficacy measurement of the trial is progression-free survival (PFS) following 24 weeks of treatment. The pre-specified evaluable primary analysis population consisted of patients who had at least one post-baseline disease computerized tomography (CT) assessment. All patients enrolled in the trial had advanced non-resectable pancreatic cancer (78% of patients having metastatic disease), and an Eastern Cooperative Oncology Group (ECOG) Performance Status score of less than or equal to 2. Under the study protocol, patients may continue to receive CCX872 for an indefinite treatment period as long as there is no evidence of disease progression. Accordingly, 48 week overall survival data is also reported. 

The results are presented in a poster entitled, "Orally Administered CCR2 Selective Inhibitor CCX872-B Clinical Trial in Pancreatic Cancer" (Abstract #276, January 20, 12:30 to 2:00 p.m. PT, Poster Session B: Cancers of the Pancreas, Small Bowel and Hepatobiliary Tract)

Data reported for CCR2 inhibitor CCX872 in combination with FOLFIRINOX are as follows:

PFS rate was 57% at week 24 in the primary analysis population; median PFS was 179 days

Overall survival rate was 52% at week 48 in the primary analysis population; median survival time was 11.5 months

The longest ongoing CCX872 treatment period for a patient in the study to date is 73 weeks (and continuing)

CCX872 has been well tolerated in the clinical trial. There is no apparent additional safety burden of combining CCX872 with FOLFIRINOX, as evidenced by an incidence and rate of adverse events in the trial to date which is consistent with data reported historically for FOLFIRINOX on its own. 

In preclinical and clinical studies, inhibition of CCR2 in pancreatic cancer has shown to decrease tumor progression by blocking recruitment and accumulation of monocytes or macrophages that are thought to have an immune suppressive character in the tumor microenvironment. The Company is also examining current immunotherapy practices using model systems with so-called checkpoint inhibitors (such as anti-PD-1 or PD-L1) combined with chemokine receptor inhibitors including CX872. While it is known that checkpoint inhibitors on their own lack efficacy in immune-insensitive cancers (including pancreatic cancer), the Company has demonstrated that the inhibition of CCR2 potentiates anti-PD-1/PD-L1 immunotherapy in preclinical models of pancreatic cancer. The Company plans to further investigate CCX872 in combination with a checkpoint inhibitor.

"It is encouraging that a large percentage of patients with the notoriously challenging disease of pancreatic cancer are still alive in this ongoing study," said Pirow Bekker, M.D., Ph.D., and Chief Medical Officer of ChemoCentryx. "Given that all patients in our study had non-operable disease, the large majority of whom were also metastatic, we believe that any improvement in overall survival is an important advancement for this patient population. We will continue to follow these patients, and we look forward to the 18-month survival analysis later this year. Additionally, we are keen to further evaluate CCX872 in combination with a checkpoint inhibitor."

CCX872 Phase Ib Trial Design
The open-label, multi-center, Phase Ib clinical trial was designed to evaluate the safety and efficacy of orally administered CCX872 plus FOLFIRINOX in 50 patients with advanced non-resectable pancreatic cancer. Patients received 150 mg CCX872 twice daily for 12 weeks. After 12 weeks, patients who achieved stable disease or better (as measured by Response Evaluation Criteria In Solid Tumors, or RECIST 1.1) were eligible to continue on study for at least an additional 12 weeks unless disease progression occurred. Per protocol, the Eastern Cooperative Oncology Group (ECOG) performance status of patients in the trial was 0, 1 or 2. The primary efficacy measurement of the trial was progression-free survival (PFS) following at least 24 weeks of treatment.

About Pancreatic Cancer
It is estimated that over 337,000 cases of pancreatic cancer are diagnosed worldwide every year. In the United States in 2016, the incidence of pancreatic cancer was approximately 53,000 people; prevalence is only negligibly higher owing to the poor survival rates on current therapy. Within five years of diagnosis, 93 percent of patients die from their disease. Current standards of care include chemotherapeutic regimens that have significant toxicities and, in a minority of cases, surgical resection.

About ChemoCentryx
ChemoCentryx is a clinical-stage biopharmaceutical company primarily focused on developing new medicines for patients with rare renal diseases. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies to treat orphan and rare diseases. Avacopan (CCX168), an inhibitor of the complement 5a receptor (C5aR), is in Phase III development for the treatment of anti-neutrophil cytoplasmic auto-antibody-associated vasculitis (AAV). Avacopan was safe, well tolerated and successful in allowing reduction and elimination of high-dose steroids, part of standard of care for AAV patients, while providing effective control of the disease in clinical studies to date. Avacopan is also being developed in patients with atypical hemolytic uremic syndrome (aHUS) and C3 glomerulopathy (C3G). CCX140, an inhibitor of the chemokine receptor known as CCR2, successfully completed a Phase II clinical trial where it was shown to be safe and well tolerated while demonstrating statistically significant improvement in proteinuria in patients with diabetic nephropathy and is currently being developed in a rare kidney disease known as focal segmental glomerulosclerosis (FSGS). Both avacopan and CCX140 are part of a Vifor Pharma-ChemoCentryx Kidney Health Alliance which provides Vifor Pharma with exclusive rights to commercialize avacopan and CCX140 in certain markets outside of the U.S. ChemoCentryx has an immuno-oncology program, which includes a distinct CCR2 inhibitor, CCX872, currently in development for the treatment of advanced non-resectable pancreatic cancer.

Forward-Looking Statements
ChemoCentryx cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "may," "could," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "intend," "predict," "seek," "contemplate," "potential," "continue" or "project" or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company's statements regarding whether CCX872 will be shown to be effective in ongoing or future clinical trials in the treatment of advanced non-resectable pancreatic cancer and whether CCX872 will be further developed in combination with a checkpoint inhibitor. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in ChemoCentryx's periodic reports filed with the SEC, including ChemoCentryx's Annual Report on Form 10-K filed with the SEC March 14, 2016 and its other reports which are available from the SEC's website (www.sec.gov) and on ChemoCentryx's website (www.chemocentryx.com) under the heading "Investors." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.