Purple Biotech Granted New Patent for NT219 in Combination With EGFR Antibody Therapy, Enhancing Global IP Protection in Major Markets

Purple Biotech Ltd. recently announced the U.S. Patent and Trademark Office has issued a patent for NT219 used in combination with epidermal growth factor receptor (EGFR) antibodies for treating cancer patients who have acquired resistance to EGFR therapies. The patent, titled “Combinations of IRS/STAT3 dual modulators and anti-cancer agents for treating cancer” addresses NT219 in combination with cetuximab (Erbitux) as well as other EGFR antibodies such as panitumumab (Vectibix) and necitumumab (Portrazza) in treating tumors resistant to EGFR therapy and in preventing or delaying cancer tumor recurrence following cessation of treatment with an EGFR therapy.

Purple Biotech’s NT219 is a first-in-class small molecule drug designed to target key cancer resistance mechanisms by degrading IRS1/2 and blocking IGF1R/IRS1 and STAT3 survival pathways.

NT219 recently advanced into a Phase 2 study in second-line patients with recurrent and/or metastatic head and neck cancer to evaluate the drug in combination with standard-of-care head and neck cancer therapies, including cetuximab and pembrolizumab. The head and neck cancer treatment market is forecast to reach $5 billion by 2030.

“This latest U.S. patent completes geographic patent protection of NT219 used in combination with cetuximab in major markets such as the United States, Europe, China and Japan,” stated Gil Efron, Purple Biotech CEO. “We believe this additional patent strongly positions us for the potential future commercialization of our novel NT219 therapy.”

Purple Biotech’s growing intellectual property portfolio for NT219 in combination with anti-cancer standard-of-care therapies includes a previously issued U.S. patent that covers the pharmaceutical combinations of NT219 with small molecule EGFR inhibitors. This patent has also been granted or allowed in major markets.

About Purple Biotech

Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance. The Company’s oncology pipeline includes CM24, NT219, and CAPTN-3. CM24 is a humanized monoclonal antibody that blocks CEACAM1, which supports tumor immune evasion and survival through multiple pathways. CEACAM1 on tumor cells, immune cells and neutrophil extracellular traps is a novel target for the treatment of multiple cancer indications. As proof of concept of these novel pathways, the Company completed a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma (PDAC) with CM24 as a combination therapy with the anti-PD-1 checkpoint inhibitor nivolumab and chemotherapy, demonstrating clear and consistent improvement across all efficacy endpoints and the identification of two potential serum biomarkers. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. A Phase 1 dose escalation study was concluded as a monotherapy and in combination with cetuximab, in which NT219 demonstrated anti-tumor activity in combination with cetuximab in second-line patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). The Company is advancing NT219 into a Phase 2 study in collaboration with the University of Colorado, to treat R/M SCCHN patients in combination with cetuximab or pembrolizumab. The Company is advancing CAPTN-3, a preclinical platform of conditionally activated tri-specific antibodies, which engage both T cells and NK cells to induce a strong, localized immune response within the tumor microenvironment. The cleavable capping technology confines the compound’s therapeutic activity to the local tumor microenvironment, thereby potentially increasing the anticipated therapeutic window in patients. The third arm specifically targets the Tumor Associated Antigen (TAA). The technology presents a novel mechanism of action by unleashing both innate and adaptive immune systems to mount an optimal anti-tumoral immune response. IM1240 is the first tri-specific antibody in development that targets the 5T4 antigen, which is expressed in a variety of solid tumors and is associated with advanced disease, increased invasiveness, and poor clinical outcomes. The Company’s corporate headquarters are located in Rehovot, Israel. For more information, please visit https://purple-biotech.com/.