On December 14, 2023 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 it has completed patient enrollment in a Phase 2 study of CM24, a multi-functional immune checkpoint inhibitor, for the treatment of pancreatic ductal adenocarcinoma (PDAC) (Press release, Purple Biotech, DEC 14, 2023, View Source [SID1234638572]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 2 study (NCT04731467), in collaboration with Bristol Myers Squibb (BMS), is evaluating CM24 in combination with BMS’s nivolumab plus chemotherapy in PDAC patients as a 2nd line treatment as compared to chemotherapy alone. The primary endpoint is overall survival (OS). Approximately 60 patients have been enrolled through 18 centers in the U.S., Spain and Israel.

The trial was fully enrolled in advance of the anticipated 2024 timeline. An interim analysis of overall survival, the primary endpoint of the study is expected during 1H 2024 and topline analysis is expected in 2H 2024.

"Having completed patient enrollment, we now look forward to reporting overall survival results in 2024. We thank the patients and their families for participating in this important and promising study, which may advance CM24 toward a pivotal study for a population in dire need of an effective alternative. Survival rates in pancreatic cancer are unfortunately very low and with CM24’s novel CEACAM1 target, we believe we may have a positive impact on extending survival," stated Purple Biotech CEO, Gil Efron.

An estimated 60,000 people are diagnosed with pancreatic cancer in the U.S. alone with a 5-year survival rate of only 12%. In patients treated with chemotherapy as a 2nd line treatment, the 5-year survival drops to 3%.