On June 17, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported the initiation of a Phase 2 clinical study evaluating NT219 in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) (Press release, Purple Biotech, JUN 17, 2025, View Source [SID1234653952]).
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NT219 is a novel small molecule designed to target two key oncogenic pathways: IRS1/2 (Insulin Receptor Substrates 1 and 2) and STAT3 (Signal Transducer and Activator of Transcription 3). NT219 induces the degradation of IRS1/2 and inhibits the phosphorylation of STAT3, thereby, blocking their respective signaling pathways. The Phase 2 study will evaluate NT219 in combination with either pembrolizumab (KEYTRUDA) or cetuximab, both of which are standard-of-care treatments in R/M SCCHN patients. Additionally, the study aims to evaluate potential biomarkers identified in a previous clinical study of NT219.
The investigator-initiated study is being conducted in collaboration with the University of Colorado Anschutz Medical Campus, and is led by Dr. Antonio Jimeno, Director of the Head and Neck Cancer Program, and the Principal Investigator, Dr. Alice Weaver. The study is structured into two single-arm cohorts: one evaluating NT219 in combination with pembrolizumab, and the other evaluating NT219 in combination with cetuximab. Each cohort will follow a Simon 2-stage design, beginning with 10 patients per arm and potentially expanding to a total of 29 patients per arm.
"We are excited to initiate this Phase 2 study evaluating NT219 in combination with standard-of-care therapies and to deliver on our milestones for this year," said Gil Efron, Chief Executive Officer of Purple Biotech. "This study marks an important milestone in our clinical development of NT219 and reflects our commitment to advancing therapies that may potentially overcome resistance and improve outcomes for the vast majority of patients with recurrent and/or metastatic head and neck cancer, who do not respond to current treatments."
This Phase 2 study builds upon encouraging results from our Phase 1 study, that demonstrated the safety and anti-tumor activity of NT219 in combination with cetuximab, as evidenced by two partial responses and five patients with stable disease. In preclinical models, NT219 has also been shown to reverse resistance to PD-1 inhibition and restore immune activity within the tumor microenvironment.
The SCCHN treatment market is projected to reach $5 billion by 2030. It is believed that the development of more effective treatments for R/M SCCHN is primarily hindered by tumor heterogeneity, therapeutic resistance, and a lack of reliable biomarkers.