REHOVOT, Israel, Oct. 06, 2023 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today reported new biomarker data for its lead oncology drug, CM24, a first-in-class anti-CEACAM1 monoclonal antibody. Data were presented at the American Association for Cancer Research (AACR) Special Conference: Pancreatic Cancer in Boston in a scientific poster titled: "Phase 1 Study of CM24 in Combination with Nivolumab in Patients with Advanced Pancreatic Cancer - Survival, Exploratory Biomarkers and Effect on Neutrophil Extracellular Traps (NETs)".
The poster shows that higher pre-treatment levels of tumor infiltrating lymphocytes that express CEACAM1may associated with longer survival in patients treated with CM24 and nivolumab.
In addition, the poster shows high expression of CEACAM1 on neutrophils and NETs , and enhanced levels of serum NETs in PDAC patients, and demonstrates for the first time that CM24 treatment significantly reduced the level of NET marker in patients' serum.
"These encouraging data, demonstrating increased survival of PDAC patients whose biopsies show higher CEACAM1-positive lymphocytes, are consistent with the CM24 Mechanism of Action (MoA) in suppressing the immune evasion and suggest CEACAM1 expressing lymphocytes as a potential biomarker for CM24 therapy" said Purple Biotech VP R&D, Dr. Hadas Reuveni. "In addition, the significant reduction in the levels of NETs in patients' serum following treatment with CM24 suggests a novel MoA that may reduce NET-related complications, especially relevant in PDAC patients, and may be used as a potential pharmacodynamic marker for CM24."
The CM24 and nivolumab combination has shown in phase 1 encouraging initial activity and safety profile in PDAC patients who have progressed after second-line therapy. CM24's novel target is CEACAM1, which is overexpressed on tumor cells and infiltrating immune cells.
CM24 is now being evaluated in a randomized Phase 2 study (NCT04731467) in combination with Bristol Myers Squib's nivolumab plus standard of care (SoC) chemotherapy, as a second line treatment for pancreatic ductal adenocarcinoma (PDAC). The primary endpoint is overall survival of patients treated with CM24 in combination with nivolumab and SoC chemotherapy vs. SoC chemotherapy alone.
"NETs and CEACAM1 will continue to be monitored and investigated in our ongoing randomized Phase 2 study of CM24 in pancreatic cancer patients," stated Purple Biotech CEO, Gil Efron. "We look forward to reporting data from this study in the near term."
The full poster can be viewed on the Purple Biotech website at https://purple-biotech.com/pipeline/#1Publications.
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. In a Phase 1/2 study of NT219, the Company is currently advancing it in a dose escalation as a monotherapy treatment of solid tumors, and in a dose escalation in combination with cetuximab for the treatment of recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN) or colorectal adenocarcinoma (CRC). These studies will be followed by an expansion phase of NT219 at its recommended Phase 2 level in combination with cetuximab in patients with recurrent and metastatic SCCHN. 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. IM1240 is a preclinical, conditionally-activated tri-specific antibody that engages both T cells and NK cells to mount a strong, localized immune response within the tumor microenvironment. The third arm specifically targets the Tumor Associated Antigen (TAA) 5T4 that is expressed in a variety of solid tumors and is correlated with advanced disease, increased invasiveness and poor clinical outcomes. IM1240 has a cleavable capping technology that confines the compound's therapeutic activity to the local tumor microenvironment, and thereby potentially increases the anticipated therapeutic window in patients. The Company's corporate headquarters are located in Rehovot, Israel. For more information, please visit https://purple-biotech.com/.
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