Lisata Therapeutics Announces Full Enrollment of Pancreatic Cancer Cohort of CENDIFOX Trial

Lisata Therapeutics, Inc. recently announced the successful completion of patient enrollment for the pancreatic cancer cohort in the Phase 1b/2a CENDIFOX trial. This investigator-initiated trial, led by Dr. Anup Kasi at The University of Kansas (KU) Cancer Center, is evaluating the safety and efficacy of certepetide (formerly LSTA1) in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers.

“The successful enrollment of the pancreatic cancer cohort represents another significant step forward in the clinical development of certepetide,” said Dr. Kristen K. Buck, Lisata’s Executive Vice President of Research and Development and Chief Medical Officer. “We are encouraged by the progress of the CENDIFOX trial and look forward to both the completion of enrollment in the remaining two cohorts and the reporting of results.”

The open-label 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. The study, conducted solely at the KU Cancer Center, aims to enroll a total of 51 patients (21 resectable and borderline resectable pancreatic cancer patients, 15 high-grade colon and appendiceal cancer patients with peritoneal metastasis, and 15 colon cancer patients with oligo-metastatic disease). It will provide Lisata with valuable pre- and post-treatment tumor tissue data for immune profiling, along with long-term patient outcome information. The trial is funded by the KU Cancer Center and Lisata is supplying certepetide.

“We are excited to collaborate with Lisata and encouraged by certepetide’s potentially diverse applicability,” said Dr. Anup Kasi, the study’s Principal Investigator at the KU Cancer Center. “We are eager to finish enrolling participants in the remaining study cohorts and to analyze the findings of each group to determine its efficacy.”

For more information on the CENDIFOX trial, please visit https://www.clinicaltrials.gov/study/NCT05121038.

Certepetide (formerly LSTA1) is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Certepetide also has the potential to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. Certepetide has been awarded Fast Track designation (US) and Orphan Drug Designation for pancreatic cancer (US and EU) as well as Orphan Drug Designation for glioma (US) and osteosarcoma (US). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (US).

Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s lead product candidate, certepetide (formerly LSTA1), is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform technology. The company expects to announce numerous milestones over the next two years and believes that its projected capital will fund operations into early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. For more information, visit www.lisata.com.