Lisata Therapeutics Completes Enrollment for Pancreatic Cancer Cohort in CENDIFOX Trial

Lisata Therapeutics, Inc., a clinical-stage pharmaceutical company focused on innovative treatments for advanced solid tumors and other serious diseases, recently announced the successful completion of patient enrollment for the pancreatic cancer cohort in their Phase 1b/2a CENDIFOX trial. This trial, which is being conducted at the University of Kansas (KU) Cancer Center under the guidance of Dr. Anup Kasi, aims to evaluate the safety and efficacy of certepetide (formerly known as LSTA1) in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers.

Dr. Kristen K. Buck, Lisata’s Executive Vice President of Research and Development and Chief Medical Officer, commented on this milestone, highlighting it as a significant step forward in the clinical development of certepetide. The trial’s progress is encouraging, and there is great anticipation for the completion of enrollment in the remaining cohorts and the subsequent reporting of results.

The CENDIFOX trial is an open-label study designed to assess the safety and therapeutic effects of combining certepetide with neoadjuvant FOLFIRINOX regimens, possibly including panitumumab, across different cancer types. The study is focused on a total of 51 patients, divided into three groups: 21 patients with resectable and borderline resectable pancreatic cancer, 15 patients with high-grade colon and appendiceal cancer with peritoneal metastasis, and 15 patients with oligo-metastatic colon cancer. Conducted exclusively at the KU Cancer Center, the trial will provide valuable data on tumor tissue for immune profiling, along with long-term patient outcomes. The KU Cancer Center is funding the study, while Lisata provides certepetide.

Dr. Anup Kasi, the Principal Investigator of the study, expressed enthusiasm about the collaboration with Lisata and the potential versatility of certepetide in treating various cancers. There is a strong drive to complete participant enrollment for the remaining cohorts and analyze the efficacy results for each group.

Certepetide is an investigational drug designed to activate a novel uptake pathway, allowing co-administered anti-cancer drugs to penetrate solid tumors more effectively. This pathway targets tumors specifically, enhancing the delivery and accumulation of anti-cancer drugs within the tumor. Furthermore, certepetide has the potential to modify the tumor microenvironment, making tumors more susceptible to immunotherapies. The drug has shown promising safety, tolerability, and clinical activity in both completed and ongoing trials focused on enhancing standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring certepetide's potential to improve various treatment modalities for a range of solid tumors.

Certepetide has been awarded multiple designations, including Fast Track and Orphan Drug Designations for pancreatic cancer in the U.S. and E.U., as well as Orphan Drug Designation for glioma and osteosarcoma in the U.S. Additionally, it has received Rare Pediatric Disease Designation for osteosarcoma in the U.S.

Lisata Therapeutics is dedicated to the discovery, development, and commercialization of innovative therapies for advanced solid tumors and other major diseases. Their lead product candidate, certepetide, utilizes the CendR Platform® technology to enhance the delivery of anti-cancer drugs to solid tumors. The company anticipates announcing numerous milestones over the next two years, with projected capital supporting operations into early 2026.

While the future holds promising potential, the company acknowledges the inherent risks and uncertainties in the development of new therapies. Lisata remains committed to navigating these challenges to bring effective treatments to patients in need.