Purple Biotech Reports Positive Data from Pancreatic Cancer Study
Clinical-stage biotechnology company, Purple Biotech (Nasdaq: PPBT) has reported additional positive interim data from its randomized, controlled, open label, multicenter Phase 2 study of CM24, in combination with nivolumab and standard of care (SoC) chemotherapy, in second-line metastatic pancreatic ductal adenocarcinoma (PDAC). Further data and top line results are expected in the second half of 2024.
“The concordant and consistent improvement in primary and all secondary endpoints including OS, PFS, ORR, DCR and CA19-9 are compelling, and the addition of a potential predictive biomarker provides further support for the potential of CM24 in combination with nivolumab plus the SoC chemotherapy regimen Nal-IRI/5FU/LV to improve clinical outcomes for those with advanced metastatic PDAC,” said Gil Efron, Chief Executive Officer of Purple Biotech.
Purple Biotech’s interim biomarker analysis measured baseline serum myeloperoxidase (MPO) as a potential clinical outcome biomarker for CM24-nivolumab therapy. The results suggest that baseline serum myeloperoxidase (MPO) may be a predictive biomarker for survival in the CM24+Nivolumab + Nal-IRI/5FU/LV arm.
Data reported at the 2024 ASCO annual meeting demonstrated reduced risk of death and cancer progression, prolongation of OS and progression free survival as well as higher objective response rate and disease control rate and decreasing CA19-9 levels in the M24+Nivolumab+Nal-IRI/5FU/LV arm.
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 NT219, CM24 and IM1240. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. A Phase 1 dose escalation study is being concluded and a Phase 2 study of NT219 at its recommended Phase 2 level in combination with cetuximab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN) is planned. CM24 is a humanized monoclonal antibody that blocks CEACAM1, an immune checkpoint protein that supports tumor immune evasion and survival through multiple pathways. The Company is advancing CM24 as a combination therapy with anti-PD-1 checkpoint inhibitors in a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma (PDAC). The Company has entered into a clinical collaboration agreement with Bristol Myers Squibb for the Phase 2 clinical trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab in addition to chemotherapy. The Company is also advancing a preclinical platform of conditionally-activated tri-specific antibodies that 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, and thereby potentially increases the anticipated therapeutic window in patients. The third arm of the antibody specifically targets the Tumor Associated Antigen (TAA). The technology presents a novel mechanism of action by unleashing both innate and adaptive immune systems to induce an optimal anti-tumor immune response. IM1240 is the platform’s lead tribody in development that targets 5T4 expressed in a variety of solid tumors and is correlated 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/.
