On April 25, 2024 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, reported that interim results from its randomized, controlled, open label, multicenter Phase 2 study of CM24, a first in class immune checkpoint inhibitor, for the treatment of pancreatic ductal adenocarcinoma (PDAC), have been selected as late-breaking abstract poster presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting which will take place on May 31 – June 4, 2024 in Chicago, Illinois (Press release, Purple Biotech, APR 25, 2024, View Source [SID1234642351]).
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The Phase 2 study (NCT04731467) is evaluating CM24 in combination with the Bristol Myers Squibb (BMS) PD-1 inhibitor nivolumab plus standard of care (SoC) chemotherapy in second line PDAC patients compared to SoC chemotherapy alone. The primary endpoint of the study is overall survival (OS), with progression free survival (PFS) and objective response rate (ORR) as secondary endpoints. The study was designed as Bayesian to evaluate the potential benefit of the experimental arm vs SoC and is not powered for hypothesis testing. Approximately 60 patients have been enrolled in the randomized study in 18 centers in the U.S., Spain and Israel. The study is in clinical collaboration with BMS. Purple Biotech retains all worldwide rights to CM24.
The interim data in the CM24/nivolumab plus SoC Nal-IRI/5FU/LV arm vs. the SoC Nal-IRI/5FU/LV control arm suggests a reduced risk of progression or death in the experimental arm, as demonstrated by PFS, supported by higher ORR and disease control rate (DCR) and decreasing CA19-9 in the experimental arm. Full data has been submitted to the ASCO (Free ASCO Whitepaper) Meeting.
Data from the gemcitabine/nab-paclitaxel arm is not yet mature, and OS data continues to mature for both the Nal-IRI/5FU/LV and gemcitabine/nab-paclitaxel arms.
"We are honored to be selected by the ASCO (Free ASCO Whitepaper) committee with our late breaking abstract poster presentation and are looking forward to presenting our interim results from our randomized Phase 2 CM24 study at the ASCO (Free ASCO Whitepaper) 2024 annual meeting." stated Gil Efron, Chief Executive Officer of Purple Biotech. "Topline data are expected by the end of this year."
Abstract LBA4143: Interim results of the Randomized Phase 2 Cohort of Study FW-2020-01 Assessing the Efficacy, Safety and Pharmacodynamics of CM24 in combination with Nivolumab and Chemotherapy in Advanced/metastatic Pancreatic Cancer.
● Date & Time: Sunday, June 1, 1:30 – 4:30 PM CDT.
● Lead Author: Teresa Macarulla, MD, PhD, Hospital Universitario Vall d’Hebron, Barcelona, Spain.