Purple Biotech has entered a Phase II trial with its small molecule drug, NT219, focusing on patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
This study aims to evaluate the safety and efficacy of the drug as a combo therapy to explore its capacity to overcome tumour resistance to standard-of-care immune checkpoint inhibitors and epidermal growth factor receptors (EGFR) blockers.
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It is structured with two single-arm cohorts, each following a Simon 2-stage approach.
In the first arm, the drug will be tested in combination with pembrolizumab, while the second will pair NT219 with cetuximab.
An initial group of 10 subjects will be enrolled per arm and will be followed by an expansion cohort of 19 additional subjects in the next stage.
Potential biomarkers from previous clinical research on NT219 will also be assessed during this study.
The trial is led by Dr Antonio Jimeno, the University of Colorado Anschutz Medical Campus’ Head and Neck Cancer Program director and professor.
Dr Antonio’s research has highlighted the significance of signal transducer and activator of transcription 3 (STAT3) in tumour resistance to various treatments.
His insights are foundational to the Phase II study, which builds on the dose determination and observed anti-tumour activity of the drug from the company’s Phase I studies.
Purple Biotech CEO Gil Efron said: “We are pleased and honoured to collaborate with Dr Jimeno and the University of Colorado Anschutz Medical Campus in support of this important study, which aims to address a significant unmet medical need in SCCHN patients who, despite encouraging results in recent mid-stage clinical studies, still have limited treatment options due to the emergence of tumour resistance to current therapies.”
In February 2023, Purple Biotech dosed the first subject in the randomised stage of a Phase II trial of CM24 in treating advanced metastatic pancreatic cancer.
