On September 10, 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 that the Examining Division of the European Patent Office has issued an intention to grant a European Patent for Application No. 20168234.1, titled ‘Combinations of IRS/STAT3 Dual Modulators and Anti-Cancer Agents for Treating Cancer’ (Press release, Purple Biotech, SEP 10, 2025, View Source [SID1234655925]).
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This application, if granted, is expected to provide broad protection for NT219 combinations with leading immunotherapies, such as anti-PD-1, PD-L1, CTLA-4, and CD20 antibodies, which are designed to enhance responsiveness in resistant cancers. It further covers combinations of NT219 with MEK inhibitors that may expand treatment sensitivity for resistant tumors. Finally, the application includes claims for combinations of NT219 with selected chemotherapies or targeted agents to address cancers that develop resistance driven by KRAS amplification or mutation. The patent term, excluding extensions, runs through 2036.
"NT219 covalently binds to Insulin Receptor Substrate (IRS1/2), leads to IRS1/2 degradation, and blocks STAT3; both targets are key drivers of drug resistance and tumor immune evasion. We believe that combining NT219 with leading immunotherapies could represent a significant opportunity to thwart cancer’s natural ability to develop resistance mechanisms," said Gil Efron, CEO of Purple Biotech. "A Phase 2 study in squamous cell carcinoma of the head and neck (SCCHN) was initiated, evaluating NT219 in combination with either pembrolizumab as proof of concept for the combination with immunotherapy, or in combination with cetuximab where we observed activity in a Phase 1 study."
A comprehensive preclinical package supports the Phase 2 clinical study, demonstrated the synergistic activity of NT219 with immunotherapy in suppressing refractory tumors across multiple indications, showing conversion of the tumor microenvironment from immunosuppressive to immunoreactive (as reported at AACR (Free AACR Whitepaper) 2023 and AACR (Free AACR Whitepaper) 2025).