On June 6, 2022 ChemoCentryx, Inc., (Nasdaq: CCXI), reported the presentation of safety results from the ongoing Phase I clinical study of CCX559, the Company’s highly potent, orally administered PD-L1 checkpoint inhibitor, in patients with advanced solid tumors during a poster session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, ChemoCentryx, JUN 6, 2022, View Source [SID1234615642]).

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In the ASCO (Free ASCO Whitepaper) poster titled, Results From an Ongoing Phase 1 Dose-Escalation Study of CCX559, an Orally Administered Small Molecule PD-L1 Inhibitor, in Patients With Advanced Solid Tumors (abstract #2593), 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.

The first-in-human Phase I study is assessing CCX559 in patients with a range of advanced solid tumors. Ten of the 13 patients enrolled have received at least two or more prior lines of systemic therapy. The primary objectives of the study are to evaluate the safety and tolerability, and to inform dose selection for the planned Phase Ib/II clinical trial.

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. There have been no treatment-related AEs reported in more than one patient.

The ASCO (Free ASCO Whitepaper) poster also includes pharmacokinetic (PK) and pharmacodynamic (PD) data that build on the positive findings presented during the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April, providing evidence that CCX559 is pharmacologically active and 120 mg once daily is a therapeutically relevant dose. Results presented during ASCO (Free ASCO Whitepaper) indicate continued dose-dependent PK exposure at Day 1 for CCX559. The mean exposure at 120 mg (n=10) remains in line with preclinical projections and continues to increase at the 180 mg level (n=1). Consistent with approved antibody inhibitors of PD-L1, CCX559 demonstrates immunomodulatory activity in first cycle of treatment.

ChemoCentryx expects to present additional findings from this ongoing Phase I study at major oncology conferences through 2022. The tumor types being evaluated in the Phase I 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 Ib/II clinical trial to measure anti-tumor effects of CCX559 more directly during the second half of 2022.

About CCX559

CCX559 is a highly potent orally administered small molecule PD-L1 checkpoint inhibitor. Preclinical characterization has 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.

The PD-L1/PD-1 interaction is one of the major immune checkpoints that limits the ability of effector T cells to destroy cancer cells. As a potential next generation therapy, an orally administered small molecule inhibitor of PD-L1 could have advantageous properties compared to approved monoclonal antibodies, such as better penetration into solid tumors, reduced immunogenicity, lack of Fc-mediated side effects and convenience of oral administration.

During 2021, ChemoCentryx initiated a first-in-human Phase I dose escalation study to evaluate the safety, tolerability, PK and PD of CCX559 in patients with various types of advanced cancer. 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.