CCX559 / Amgen - LARVOL DELTA

A Study To Determine The Safety, Tolerability, Pharmacokinetics And Recommended Phase 2 Dose Of CCX559 In patients With Solid Tumors (ANZCTR) - P1 | N=90 | Terminated | Sponsor: ChemoCentryx, Inc | Active, not recruiting ➔ Terminated

Trial termination • Oncology • Solid Tumor

CCX559 is a potent, orally-administered small molecule PD-L1 inhibitor that induces anti-tumor immunity. (PubMed, PLoS One) - "In a cynomolgus monkey pharmacodynamic study, CCX559 increased plasma levels of soluble PD-L1. These results support the clinical development of CCX559 for solid tumors; CCX559 is currently in a Phase 1, first in patient, multicenter, open-label, dose-escalation study (ACTRN12621001342808)."

IO biomarker • Journal • Immune Modulation • Oncology • Solid Tumor • CD80

Results from an ongoing open-label, multicenter, phase 1 trial of CCX559, an orally administered small molecule PD-L1 inhibitor, in patients with advanced solid tumors (SITC 2022) - "Additional PD data, together with the safety and PK profile, will be presented. Trial Registration ANZCTR registration ACTRN12621001342808"

Clinical • P1 data • Oncology • Solid Tumor • CD4 • CD8 • CXCL10 • CXCL11 • CXCL13 • CXCL8 • IFNG • IL1B

The small molecule PD-L1 inhibitor CCX559 preferentially accumulates in tumors, resulting in depletion of cell-surface PD-L1 in a murine preclinical model (SITC 2022) - "The in vivo properties of CCX559 suggest that PD-L1 inhibition in tumors may be achieved at relatively low drug levels in the periphery, thus mitigating potential risk of adverse events. No DLTs, treatment-related SAEs or severe (Grade 3 or higher) AEs have been reported in an ongoing first-in-human dose escalation trial with CCX559 (ACTRN12621001342808)."

Preclinical • Oncology

Preliminary data from an ongoing phase 1 dose-escalation study of CCX559, an orally administered small molecule PD-L1 inhibitor, in patients with advanced solid tumors. (ASCO 2022) - "Initial results from the phase 1 dose-escalation study of CCX559 indicate on-target PD effects consistent with PD-L1 inhibition. Updated PD data, together with the safety and PK profile, will be presented."

Clinical • P1 data • Oncology • Solid Tumor • CD4 • CD8 • CXCL10 • CXCL11 • CXCL9 • IFNG

ChemoCentryx Announces Upcoming Presentations for Orally Administered PD-L1 Inhibitor, CCX559, at the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "ChemoCentryx...announced two upcoming poster presentations for CCX559, the Company’s investigational, highly potent, orally administered PD-L1 checkpoint inhibitor, at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, held November 8-12, 2022, in Boston, MA....Two poster presentations planned for CCX559, including results from ongoing Phase I clinical study in patients with advanced solid tumors, and preclinical evidence from murine model."

P1 data • Preclinical • Oncology • Solid Tumor

ChemoCentryx Reports Safety Results Available from Ongoing Phase I Trial of Orally Administered PD-L1 Inhibitor, CCX559, at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - P1 | N=13 | "In the ASCO poster...ChemoCentryx reported patient baseline characteristics and safety data available from the ongoing study as of April 27, 2022, from the first 13 patients enrolled across four dose cohorts: 30 mg, 60 mg, 120 mg, and 180 mg....To date, there have been no dose limiting toxicities (DLTs) or treatment-related serious or severe (≥ grade 3) adverse events (AEs) reported. Two patients receiving 120 mg once daily CCX559 presented with three probable immune-related AEs, which provides supportive evidence of immune activation....ChemoCentryx expects to present additional findings from this ongoing Phase I study at major oncology conferences through 2022."

P1 data • Oncology • Solid Tumor

ChemoCentryx Announces Abstracts at June Rheumatology, Oncology and Nephrology Conferences (GlobeNewswire) - "ChemoCentryx... announced upcoming abstract presentations at three key medical conferences taking place in June, which highlight TAVNEOS (avacopan), an orally administered selective complement 5a receptor (C5aR) inhibitor, and its role in ANCA-associated vasculitis and potential application in C3 glomerulopathy, as well as the immuno-oncology potential of CCX559, an orally administered small molecule PD-L1 inhibitor."

P1 data • Oncology • Solid Tumor

CCX559, an orally administered small molecule PD-L1 inhibitor for the treatment of solid tumors (AACR 2022) - "Safety pharmacology studies in preclinical animal species demonstrated pharmacokinetics and an acceptable safety profile for CCX559, which supported the initiation of human trials in patients with advanced tumors. Prior findings from toxicology studies were consistent with immune modulation, including consumptive coagulopathy, increased white blood cell counts, and changes in IL-6 plasma levels. A Phase 1, first in patient, multicenter, open-label, dose-escalation study was initiated, with a starting dose of once-daily (QD) oral dosing at 30 mg."

Oncology • Solid Tumor • IL6

ChemoCentryx Reports Pharmacokinetic and Pharmacodynamic Results from Ongoing Phase I Trial of Orally Administered PD-L1 Inhibitor, CCX559, at American Association for Cancer Research (AACR) Annual Meeting 2022 (GlobeNewswire) - P1 | N=90 | "ChemoCentryx reported initial data available to date from patients enrolled in the first three dose cohorts in the ongoing Phase I study...PK evaluation shows human CCX559 exposure is in line with preclinical projections; PD activity results from the first cycle of treatment indicate that CCX559 is immunomodulatory; The PD activity of CCX559 is consistent with approved antibody inhibitors of PD-L1, in the extent and kinetics of the observed Th1 responses....ChemoCentryx expects to present additional findings from this ongoing Phase I study at major oncology conferences through 2022. During the second half of 2022, the Company plans to advance CCX559 into a Phase Ib/II clinical trial to measure anti-tumor effects of CCX559 more directly."

New P1/2 trial • P1 data • Oncology • Solid Tumor

ChemoCentryx Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Highlights (GlobeNewswire) - "CCX559 Clinical Development: ChemoCentryx plans to report initial data from the Phase I study in 2022 and initiate a Phase Ib/II clinical study in selected patient populations in the second half of 2022."

New P1/2 trial • P1 data • Oncology • Solid Tumor

A Study To Determine The Safety, Tolerability, Pharmacokinetics And Recommended Phase 2 Dose Of CCX559 In patients With Solid Tumors (ANZCTR) - P1; N=90; Recruiting; Sponsor: ChemoCentryx, Inc

Clinical • New P1 trial • Oncology • Solid Tumor • MRI

[VIRTUAL] CCX559 is a potent orally-administered small molecule PD-L1 inhibitor that induces anti-tumor immunity (AACR 2021) - "Using structural information and focused medicinal chemistry, we identified CCX559 as a potent inhibitor of PD-L1 interaction with PD-1. CCX559 prevented PD-L1/PD-1 inhibition of TCR signaling in a cell-based reporter assay, increased IFNγ secretion in allogeneic MLR assays, and increased tumor cell killing by human PBMCs. We demonstrated that CCX559 potentially employs multiple mechanisms to inhibit PD-L1, which are distinct from those published for human anti-PD-L1 antibodies."

IO biomarker • Oncology • Solid Tumor • IFNG

ChemoCentryx Reports First Quarter 2021 Financial Results and Recent Highlights (GlobeNewswire) - "The Company plans to initiate Phase I clinical development of CCX559 in Q2 2021."

New P1 trial • Oncology

ChemoCentryx’s Oral PD-L1 inhibitor, CCX559, Featured in Poster Presentation at the 2021 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - “ChemoCentryx, Inc…announced that the Company’s orally-administered small molecule PD-L1 inhibitor, CCX559, will be featured in a poster presentation at the virtual 2021 Annual Meeting of the American Association for Cancer Research (AACR). The poster presentation, which showcases CCX559’s ability to induce anti-tumor immunity, will go live on Saturday, April 10 at 8:30 a.m. ET as part of the Novel Antitumor Agents Session (PO.ET06.03)…In murine tumor models, orally administered CCX559 reduced tumor growth similarly to a clinically-approved anti-human PD-L1 antibody…the Company plans to advance CCX559 into clinical development in the first half of 2021.”

New trial • Preclinical • Oncology