ChemoCentryx Releases Phase 1 Data of CCX559, Consistent With Preclinical Results
Investigators report that the 2 individuals receiving the 120-mg dosage had 3 probable immune-related adverse events, which provides supportive evidence of immune activation.
ChemoCentryx announced the presentation ofreleased safety results from the ongoing phase 1 clinical study of CCX559, a highly potent, orally administered PD-L1 checkpoint inhibitor, in individuals with advanced solid tumors, during a poster session at the 2022 American Society of Clinical Oncology Annual meeting.1
Preclinical results have demonstrated that CCX559 blocks binding to PD-1 and CD80 and prevents PD-L1 inhibition of T cell activation. CCX559, when orally administered in animal models, demonstrated anti-tumor efficacy, including the ability to induce complete responses.1
Investigators reported patient baseline characteristics and safety data available from the ongoing study, as of April 27, 2022, from the first 13 patients enrolled across the 4 dose cohorts, including 30 mg, 60 mg, 120 mg, and 180 mg.1
The individuals included in the study had a range of advanced solid tumors, and 10 individuals had received at least 2 or more prior lines of systemic therapy.1
The primary objectives were to evaluate the safety and tolerability, as well as to help investigators choose the dose selection for the phase 1b/2 clinical trial.1
To date, there have been no dose limiting toxicities or reported treatment-related serious or severe adverse events (AEs). The 2 individuals receiving the 120 mg of CCX559 daily had 3 probable immune-related AEs, which provides supportive evidence of immune activation.1
There were no treatment-related AEs reported in more than 1 individual.1
The poster presented at ASCO included pharmacodynamic and pharmacokinetic and pharmacodynamic data that built on the findings presented during the 2022 American Association for Cancer Research Annual Meeting. This presentation provided evidence that CCX559 is pharmacologically active, and the 120-mg dosage daily is a therapeutically relevant dose.2
Additionally, the previous study was a first-in-human phase 1 dose escalation study that was meant to evaluate the pharmacodynamic, pharmacokinetic, safety, and tolerability,pharmacokinetic, and pharmacodynamic at the 30- mg, 60- mg, and 120-mg dosages.2
The results presented at ASCO showed continued dose-dependent pharmacokinetic exposure at day 1 for the drug. The mean exposure for 120 mg remains consistent with preclinical projections and continues to increase at the 180-mg dosage.1
CCX559 demonstrated immunomodulatory activity in the first cycle of treatment, which was consistent with approved antibody inhibitors of PD-L1.1
The company is expected to present additional findings of the ongoing phase 1 study atot major oncology conferences through 2022. The tumor types being evaluated in the study are not known to be responsive to treatment with anti-PD-1/PD-L1 therapies, and the company plans to advance CCX559 into a phase 1b/2 clinical trial to measure anti-tumor effects of the drug more directly. This is set to take place during the second half of 2022.1
1. 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. ChemoCentryx. New release. June 6, 2022. Accessed June 6, 2022. Email.
2. 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. ChemoCentryx. April 13, 2022. Accessed June 6, 2022. https://ir.chemocentryx.com/news-releases/news-release-details/chemocentryx-reports-pharmacokinetic-and-pharmacodynamic-results