Purple Biotech Announces First Patient Dosed in Open Label, Randomized Part of CM24 Phase 2 Clinical Trial

Purple Biotech Ltd. recently announced the first patient has been dosed in the randomized part of the open label Phase 2 clinical trial evaluating CM24 in the treatment of advanced metastatic pancreatic cancer (PDAC).

The ongoing Phase 2 trial is investigating CM24, a novel, first-in-class monoclonal antibody that targets CEACAM1, which promotes tumor immune evasion. The study design compares, in a randomized fashion, treatment with CM24 combined with the PD-1 immune checkpoint inhibitor nivolumab and standard of care (SoC) chemotherapy vs. SoC chemotherapy in second line PDAC patients. Purple Biotech has now treated the first patient in this randomized Phase 2 study that is designed to include approximately 30 patients in the experimental cohort and approximately additional 30 patients in the control cohort. The Company has already enrolled 10 patients in the safety run-in part of the trial during which no dose-limiting toxicities (DLTs) have been observed to date. The study is currently being conducted in 11 sites in the United States, Spain and Israel, and Purple Biotech expects to open approximately 10 additional sites in the upcoming months. The primary endpoint of this randomized part of the trial is overall survival. The Company expects to share interim results in the second half of 2023 and a topline report on the overall study by the end of 2024.

“We are excited with the progress made in this study as we start its randomized part,” said Gil Efron, Chief Executive Officer of Purple Biotech. “Patients with metastatic pancreatic cancer such as those we are enrolling in our ongoing trial have very few therapeutic options, with relatively short duration of survival. If this study is successful, it may open a path for a short time to market.”

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 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, visit  https://purple-biotech.com/.