Lisata and WARPNINE Complete First Stage of ILSTA Pancreatic Cancer Trial in Australia

Lisata and WARPNINE Cleared One Stage of their ILSTA trial in Australia

Announcement

The warpnine incorporated, Western Australia’s non-profit clinical research organization for rare, pancreatic, and gastrointestinal cancers, and Lisata Therapeutics Inc., a pharmaceutical company popular for innovative therapies for extreme disease and treatment of solid tumors, completed patient enrollment in the phase 1b/2a ILSTA trial (ACTRN12623000223639) in Australia. The study is currently evaluating certepetide (formerly lsta1), which is one of Lisata’s exclusive IRGD cyclic peptide product candidates. Along with the compilation of immunotherapy and standard of care (SOC) chemotherapy as a primary treatment in a localized non-resectable pancreatic ductal adenocarcinoma (PDAC). This study was organized at St john of God Subiaco Hospital, a private hospital with an excellent clinical trial group in the southern hemisphere.

Trial

The phase 1b/2a safe, single-center ILSTA trial was conducted at a leading center in Western Australia for innovation and clinical research with a successful track record in its past drug development research. The study focuses on practicing and evaluating certepetide in merger with SOC chemotherapy (gemcitabine and nab-paclitaxel) and SOC immunotherapy (durvalumab), in comparison to SOC alone in advanced PDAC patients. This partnership is an example of the strength of the togetherness of global expertise with local professionals to enable medication for the helpless pancreatic cancer patients. The collaboration has combined the clinical strategy and the drug supply of Lisata. The financial support and operational execution from Warp Nine and the drug supply from AstraZeneca are huge contributions to the trial.

Further, under ILSTA trial the participants were classified into three treatment cohorts like (1;1;4 ratio); cohort 1 (n=5) received soc chemotherapy with placebo durvalumab and certepetide. The second cohort includes (n=5) receiving soc chemotherapy + certepetide and placebo durvalumab. The third cohort consist of (n=20) receiving soc chemotherapy along with certepetide and durvalumab.

The updated data was revealed at the ESMO 2025 gastrointestinal cancers (ESMO-GI) congress on 3rd July 2025. The abstract of the data is now on the ESMO-GI website: https://cslide.ctimeetingtech.com/coasis_21393/attendee/confcal_1/presentation/list?q=lsta-1.

Views and Statements

Executive vice president of research and development and chief medical officer of Lisata, MD, Kristen K. Buck, expressed her view, saying, “It is very important to know that the first study, which is under evaluation, is for detecting diseases rather than metastatic PDAC. We expect the final data to be encouraging in the same way as the first stage of the trial was.”

Chief executive officer of WARPNINE, Meg Croucher, said, “We are proud of this achievement that indicates our team's and partners at St John of god Subiaco Hospital’s dedication.”