Purple Biotech Reports Biomarker Data from CM24 Phase 1 Dose Escalation Study
Reduction in neutrophil extracellular traps (NETs) markers
Potential association between patient survival and CEACAM1 positive lymphocytes
REHOVOT, Israel, March 16, 2023 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies that harness the power of the tumor microenvironment (TME) to overcome tumor immune evasion and drug resistance, today provided new results from exploratory analyses conducted as part of a Phase 1 dose escalation study that assessed the safety and tolerability of CM24 plus nivolumab (NCT04731467). The study enrolled 14 patients with advanced cancers including 11 patients with pancreatic adenocarcinoma (PDAC), two patients with colorectal adenocarcinoma (CRC) and one patient with papillary thyroid cancer. The analyses conducted in eight evaluable PDAC patients demonstrate clinically meaningful and durable reductions in serum myeloperoxidase, a biomarker for NETs, following treatment with CM24 plus nivolumab, immediately and 15 days after the first administration. In addition, analyses of tumor samples derived from the evaluable PDAC patients suggest that patient survival may be positively associated with higher levels of CEACAM1+ tumor-infiltrating lymphocytes in the TME. These results, along with additional data from this clinical study, are part of the Company’s effort aimed at identifying and evaluating the potential utility of a biomarker to optimize patient selection and treatment. Further study results on this topic will be presented at an upcoming medical conference.
NETs are web-like DNA structures and are covered with cancer-promoting proteins that are released by activated neutrophils and that have been shown to engulf tumors and promote immune evasion, tumor progression and metastases. When CEACAM1 is attached to NETs, it becomes a focal point of adhesion for cancer cells and, therefore, is suggested as a potential therapeutic target for preventing metastatic progression and immune evasion. In preclinical studies, CM24 has been shown to bind directly to NETs and to inhibit NET-induced cancer cell migration.
CM24, a first-in-class monoclonal antibody with the potential to treat multiple cancers, blocks CEACAM1, an immune checkpoint protein that supports tumor immune evasion and survival through multiple pathways. The Company is evaluating CM24 in patients with metastatic pancreatic cancer (PDAC) in combination with the PD-1 inhibitor nivolumab and chemotherapy in a randomized Phase 2 study. The primary endpoint of this Phase 2 study is to evaluate preliminary efficacy through overall survival in second-line PDAC.
"These encouraging biomarker results provide initial evidence of certain mechanistically relevant biomarkers and may enable us to implement a biomarker-driven strategy that could identify patients who will benefit from CM24," said Gil Efron, Chief Executive Officer, Purple Biotech. “We look forward to further data that may establish these findings in our ongoing randomized Phase 2 clinical study evaluating CM24 in combination with nivolumab and chemotherapy for treatment of PDAC."
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 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 and chemotherapy 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 trial 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 of IM1240 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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