Purple Biotech Ltd. announced 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) Annual Meeting which will take place on May 31 ? June 4, 2024 in Chicago, Illinois. 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 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.