On February 14, 2023 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 to overcome tumor immune evasion and drug resistance, reported that 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) (Press release, Purple Biotech, FEB 14, 2023, View Source;id=254755&p=2258208&I=1206939-c7Z3G6f3m8 [SID1234627190]).
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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."