— Planned posters and an oral presentation will highlight data from the trials that supported the approval of TAVNEOS® (avacopan) for patients with ANCA-associated vasculitis; additional poster will cover expression of kidney C5aR —
SAN CARLOS, Calif., Oct. 17, 2022 (GLOBE NEWSWIRE) — ChemoCentryx, Inc., (Nasdaq: CCXI), today announced planned presentations covering TAVNEOS® (avacopan), an orally administered selective complement 5a receptor (C5aR) inhibitor, at the American Society of Nephrology (ASN) Kidney Week 2022 and American College of Rheumatology (ACR) Convergence 2022 annual meetings taking place in November.
| American Society of Nephrology Kidney Week 2022, November 3-6, Orlando Renal Recovery for Patients with Baseline eGFR ≤20 in Avacopan ADVOCATE Trial |
| Session Title: Glomerular Diseases: Clinical, Outcomes, Trials – II Abstract Number: FR-PO651 Presenter: Frank Cortazar, M.D. Date and Time: November 4, 2022, 10:00 a.m. – 12:00 p.m. ET Location: Exhibit Hall, West Building |
| Integrated Safety of Avacopan in ANCA-Associated Vasculitis |
| Session Title: Glomerular Diseases: Clinical, Outcomes, Trials – III Abstract Number: SA-PO696 Presenter: David Jayne, M.D. Date and Time: November 5, 2022, 10:00 a.m. – 12:00 p.m. ET Location: Exhibit Hall, West Building |
| Kidney C5aR is Expressed in Resident Macrophages, Tubular Epithelial Cells, and in Association with Fibrosis |
| Session Title: Glomerular Diseases: IgA and Complement-Mediated GN Abstract Number: SA-PO633 Presenter: Carolyn Dunlap Date and Time: November 5, 2022, 10:00 a.m. – 12:00 p.m. ET Location: Exhibit Hall, West Building |
| ASN Kidney Week posters are viewable as ePosters during the entire conference for conference registrants. |
| American College of Rheumatology Convergence 2022, November 10-14, Philadelphia Recovery of Renal Function Among ANCA-Associated Vasculitis Patients with Baseline eGFR ≤20 in the Avacopan ADVOCATE Trial |
| Session Title: Abstracts: Vasculitis – ANCA-Associated Abstract Number: 525 Presenter: Frank Cortazar, M.D. Oral Presentation Date and Time: November 12, 2022, 3:15 – 3:25 p.m. ET Location: Room 103 |
| ANCA-Associated Vasculitis Treated with Avacopan versus a Standard Prednisone Taper: Glucocorticoid Toxicity Index Scores by Domain |
| Session Title: Vasculitis – ANCA-Associated Poster II: Treatment Efficacy, Clinical Outcomes, Biomarkers Abstract Number: 1076 Presenter: Naomi Patel, M.D. Ignite Talk Date and Time: November 13, 2022, 10:10 – 10:15 a.m. ET Location: Stage A |
| Safety of Avacopan in ANCA-Associated Vasculitis: Combined Data from Three Clinical Trials |
| Session Title: Vasculitis – ANCA-Associated Poster II: Treatment Efficacy, Clinical Outcomes, Biomarkers Abstract Number: 1077 Presenter: Peter Merkel, M.D., MPH Ignite Talk Date and Time: November 13, 2022, 10:15 – 10:20 a.m. ET Location: Stage A |
| Glucocorticoid Use and Related Adverse Events in ADVOCATE Trial of Avacopan in ANCA-Associated Vasculitis |
| Session Title: Vasculitis – ANCA-Associated Poster II: Treatment Efficacy, Clinical Outcomes, Biomarkers Abstract Number: 1078 Presenter: Emil deGoma, M.D. Poster Session Date and Time: November 13, 2022, 9:00 – 10:30 a.m. ET Location: Virtual |
| ACR Convergence posters are viewable as ePosters during the entire conference for conference registrants. |
INDICATION
TAVNEOS® (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Serious hypersensitivity to avacopan or to any of the excipients.
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for six months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risk and benefit before administering this drug to a patient with liver disease.
Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including one serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be re-administered unless another cause has been established.
Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for six months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation and consult with experts before resuming.
Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection or who have been to places where certain infections are common.
ADVERSE REACTIONS
The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased and paresthesia.
DRUG INTERACTIONS
Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates.
Please see Full Prescribing Information and Medication Guide for TAVNEOS.
About TAVNEOS® (avacopan)
TAVNEOS (avacopan), approved by the FDA as an adjunctive treatment of ANCA-associated vasculitis, is a first-in-class, orally administered small molecule that employs a novel, highly targeted mode of action in complement-driven autoimmune and inflammatory diseases. While the precise mechanism in ANCA vasculitis has not been definitively established, TAVNEOS, by blocking the complement 5a receptor (C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, is presumed to arrest the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA vasculitis. TAVNEOS’s selective inhibition of only the C5aR is believed to leave the beneficial C5a pathway through the C5L2 receptor functioning normally.
ChemoCentryx is also developing TAVNEOS for the treatment of patients with C3 glomerulopathy (C3G), severe hidradenitis suppurativa (HS), and lupus nephritis (LN). The US Food and Drug Administration granted TAVNEOS orphan drug designation for ANCA-associated vasculitis and C3G. The European Commission has granted orphan medicinal product designation for TAVNEOS for the treatment of two forms of ANCA-associated vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener’s granulomatosis), as well as for C3G. TAVNEOS has not been approved for indications discussed as in development, and the safety and efficacy of those uses has not been established.
About ANCA-Associated Vasculitis
ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated. Currently, treatment for ANCA-associated vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with the administration of daily glucocorticoids (steroids) for prolonged periods of time, which can be associated with significant clinical risk including death from infection.
About ChemoCentryx
ChemoCentryx is a biopharmaceutical company commercializing and developing new medications for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally administered therapies. In the United States, ChemoCentryx markets TAVNEOS® (avacopan), the first approved orally administered inhibitor of the complement 5a receptor as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis. TAVNEOS is also in late-stage clinical development for the treatment of severe hidradenitis suppurativa (HS) and C3 glomerulopathy (C3G).
ChemoCentryx is also developing CCX559, a highly potent orally administered small molecule PD-L1 checkpoint inhibitor, for the treatment of patients with solid tumors. A Phase I dose escalation study for CCX559 is ongoing and ChemoCentryx plans to advance to a Phase Ib/II study in early 2023.
Additionally, ChemoCentryx has early-stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer. For more information about the Company visit www.ChemoCentryx.com.
TAVNEOS® is a registered trademark of ChemoCentryx, Inc. For more information, please see the Full Prescribing Information and Medication Guide, available at TAVNEOS.com.
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 the achievement of anticipated goals and milestones. 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 on March 1, 2022, 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.
ChemoCentryx Contacts
Investors:
Bill Slattery, Jr.
Vice President, Investor Relations
& Corporate Communications
650.210.2970
bslattery@chemocentryx.com
Media:
Alex Straus
Investor Relations & Corporate
Communications Manager
astraus@chemocentryx.com
