Wybiologics Reveals Interim Results of 'YBL-006' Phase 1 Clinical Trial at European Society for Medical Oncology

[Asia Economy Reporter Jihee Kim] Y-Biologics announced on the 17th that it plans to present the interim results of the dose escalation cohort of the Phase 1 clinical trial of YBL-006 at the European Society for Medical Oncology (ESMO) 2021.

Y-Biologics received approval for the Phase 1 clinical trial of YBL-006 in South Korea and Australia in May last year and has been conducting the dose escalation clinical trial. The first dosing in Australia began on July 1. At the American Society of Clinical Oncology (ASCO) held in June, interim results of the Phase 1 clinical trial of YBL-006 targeting solid tumors were presented.

YBL-006 is an immuno-oncology drug candidate independently developed by Y-Biologics. Immuno-oncology drugs work by inducing the body's immune response to attack cancer cells. YBL-006 targets ‘PD-1’, an immune checkpoint inhibitory protein on the surface of cancer cells. Notably, at this ESMO presentation, Y-Biologics attracted attention by utilizing Lunit’s AI-based tissue analysis biomarker ‘Lunit Scope IO’, from the leading medical AI company, in the Phase 1 clinical trial.

According to the ESMO poster presented by Y-Biologics, YBL-006 was administered intravenously starting with 0.5 mpk to the first patient, followed by dose escalation to 2, 5, and 10 mpk. In the dose escalation cohort, safety, pharmacokinetics (PK), receptor occupancy (RO) of PD-1, blood levels of IFN-γ (Interferon-gamma), and tumor response were investigated. A total of 11 patients with advanced solid tumors were enrolled in the dose escalation cohort.

YBL-006 showed a linear PK profile in the area under the blood concentration-time curve (AUC) evaluation as the dose increased. PD-1 RO and blood IFN-γ increased 3 to 4 times 8 hours after the first dose. No dose-limiting toxicity (DLT) or death related to YBL-006 administration occurred. Common adverse effects related to drug administration such as rash, fatigue, fever, and hypothyroidism were observed.

Among 10 patients evaluated for tumor response, one patient with penile squamous cell carcinoma showed a complete response (CR) at 2 mpk dosing, and one patient with anal squamous cell carcinoma showed a partial response (PR) at 2 mpk dosing. Tumor responses lasted for more than 30 weeks and 14 weeks, respectively. Two patients showed stable disease (SD).

Biomarker analysis of patients who responded showed high tumor mutation burden and tumor-infiltrating lymphocyte analysis results using Lunit Scope IO. The clinical objective response rate was highest at 2 mpk. A Y-Biologics official stated, "No dose-limiting toxicity (DLT) occurred even when the drug dose was increased to 10 mpk, and the maximum tolerated dose (MTD) was not reached. Based on these results, we observed that YBL-006 has sufficient tolerability and adverse reactions caused by the drug are manageable."

Meanwhile, Y-Biologics plans to conduct a dose expansion cohort using a fixed-dose administration method for YBL-006 and aims to proceed with a Phase 2 clinical trial next year.

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