Lisata Therapeutics, Inc. (Nasdaq: LSTA) has announced the completion of patient enrollment in all three cohorts of the Phase 1b/2a CENDIFOX trial. This open-label, investigator-initiated trial, led by Dr. Anup Kasi at The University of Kansas (KU) Cancer Center, is evaluating the safety and efficacy of Lisata’s iRGD cyclic peptide product candidate, certepetide, in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers. The company expects to report results from this study in 2025.
Trial Design and Patient Population
The CENDIFOX trial is designed to assess the safety and therapeutic effects of combining certepetide with neoadjuvant FOLFIRINOX regimens, with or without panitumumab, across pancreatic, colon, and appendiceal cancers. Conducted solely at the KU Cancer Center, the study enrolled a total of 66 patients, comprising 35 with resectable and borderline resectable pancreatic cancer, 18 with high-grade colon and appendiceal cancer with peritoneal metastasis, and 13 with colon cancer with oligo-metastatic disease. The trial will provide Lisata with valuable pre- and post-treatment tumor tissue data for immune profiling, along with long-term patient outcomes information. The trial is funded by the KU Cancer Center, with Lisata supplying certepetide.
Certepetide's Mechanism of Action
Certepetide, an internalizing RGD (iRGD) cyclic peptide product, is an investigational drug designed to selectively activate the C-end rule active transport mechanism in a tissue-specific manner. This results in systemically co-administered agents more efficiently penetrating and accumulating in the tissue. Certepetide has demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing oncology clinical trials, showing its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer, as well as the combination of chemotherapy and immunotherapy in a variety of solid tumors.
Management Commentary
"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," stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. "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, added, "We are delighted to complete enrollment in all three cohorts in the CENDIFOX study and are encouraged by certepetide’s potential to improve outcomes for patients with advanced solid tumors. We are eager to analyze the data from each cohort to determine the efficacy of this novel therapy."
