Lisata Therapeutics Inc (NASDAQ:LSTA) announced that it has completed patient enrollment in all three cohorts of its Phase 1b/2a CENDIFOX trial evaluating the safety and efficacy of Lisata’s investigational drug certepetide in combination with FOLFIRINOX-based therapies for pancreatic, colon and appendiceal cancers.
Certepetide is a cyclic peptide designed to enhance the delivery of anti-cancer drugs by activating a unique pathway that helps them target and penetrate solid tumors more effectively.
The CENDIFOX trial has enrolled 66 patients, including 35 with resectable or borderline resectable pancreatic cancer, 18 with high-grade colon and appendiceal cancer with peritoneal metastasis, and 13 with colon cancer and oligo-metastatic disease.
It will provide Lisata with pre- and post-tumor tissue information for immune profiling as well as long-term patient outcome data.
The investigator-initiated trial is being funded by the University of Kansas (KU) Cancer Center with Lisata supplying certepetide.
“The successful enrollment of all three cohorts in the CENDIFOX trial is another significant milestone, bringing us closer to validating certepetide’s potential as a transformative treatment for advanced solid tumors,” Lisata chief medical officer Dr Kristen Buck said.
“By addressing the unmet medical needs of patients with solid tumors, we aim to improve patient outcomes and augment the standard-of-care paradigm. We are excited about the progress of the CENDIFOX trial and eagerly anticipate reporting the results from this important study in 2025.”
Dr Anup Kasi, the study’s principal investigator at the KU Cancer Center, expressed excitement about the enrollment milestone.
“[We] are encouraged by certepetide’s potential to improve outcomes for patients with advanced solid tumors,” Dr Kasi said. “We are eager to analyze the data from each cohort to determine the efficacy of this novel therapy.”