Lisata Therapeutics announced encouraging preliminary data from the pancreatic ductal adenocarcinoma cohort of its Phase 1/2a CENDIFOX trial, showing that its investigational drug certepetide enhanced the effectiveness of standard chemotherapy in patients with resectable and borderline resectable pancreatic cancer. The investigator-initiated trial, led by Dr. Anup Kasi at The University of Kansas Cancer Center, evaluated certepetide in combination with FOLFIRINOX-based therapies.
Clinical Outcomes Show Promise
Among 35 patients enrolled in the pancreatic cancer cohort, 10 completed the protocol-prescribed pre-surgical courses of therapy and were eligible for pancreatic cancer resection. In these 10 patients, the combination achieved a 50% R0 resection rate, meaning no residual cancer remained at surgical margins, while 70% experienced a pathologic partial response.
The treatment demonstrated promising early survival data, with a 60% two-year overall survival rate and 12-month median disease-free survival. Importantly, the combination of certepetide with FOLFIRINOX was safe and feasible, with no serious adverse events attributed to certepetide.
"The initial results from the CENDIFOX trial are very encouraging, showing that certepetide can enhance the effectiveness of standard-of-care chemotherapy in pancreatic cancer," stated Dr. Kristen K. Buck, Executive Vice President of Research and Development and Chief Medical Officer of Lisata. "We believe these findings are a significant step forward in a disease with few beneficial treatment options."
Immune System Activation
Analysis of tumor tissue revealed enhanced immune cell infiltration along with increased expression of immune markers including CD68, PD-1, and PD-L1. These findings support the potential of certepetide to transform pancreatic tumors from "immune-cold" to "immune-hot," which may make them more responsive to immunotherapies.
"The ability of certepetide to improve drug delivery and influence the tumor microenvironment may offer a potential new and exciting treatment approach for pancreatic cancer," stated Dr. Anup Kasi, the trial's principal investigator. "We are optimistic studies like CENDIFOX will pave the way for more effective combination therapies for difficult-to-treat solid tumor cancers."
Addressing Critical Medical Need
Pancreatic cancer ranks as the 6th leading cause of cancer mortality worldwide, with a five-year survival rate of just 13%. This underscores the aggressive nature of the disease and the limited efficacy of existing treatments, highlighting the significant need for new therapeutic approaches.
About Certepetide
Certepetide is an investigational internalizing RGD cyclic peptide designed to activate a novel uptake pathway that allows co-administered anti-cancer drugs to target and penetrate solid tumors more effectively. The drug actuates this active transport system in a tumor-specific manner, resulting in more efficient penetration and accumulation of systemically administered anti-cancer drugs in tumors.
The compound has received multiple regulatory designations including Fast Track designation and Orphan Drug Designation for pancreatic cancer in both the U.S. and E.U., as well as Orphan Drug Designation for glioma and osteosarcoma in the U.S. Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma.
The preliminary results were presented at the American Association for Cancer Research Special Conference in Cancer Research: Advances in Pancreatic Cancer Research in Boston, Massachusetts.
