Lisata Therapeutics & WARPNINE Announce iLSTA Trial Enrollment Completion & Provide Preliminary Data Update
Lisata Therapeutics, Inc. and WARPNINE Incorporated recently announced the successful completion of patient enrollment in the Phase 1b/2a iLSTA trial (ACTRN12623000223639) in Australia. The study is evaluating certepetide (formerly LSTA1), Lisata’s proprietary iRGD cyclic peptide product candidate, in combination with standard-of-care (SoC) chemotherapy and immunotherapy as a first-line treatment in locally advanced non-resectable pancreatic ductal adenocarcinoma (PDAC) and was conducted wholly at St John of God Subiaco Hospital, a tertiary private hospital with one of the busiest clinical trial units in the Southern Hemisphere.
“The completion of patient enrollment in the iLSTA trial marks a pivotal moment for Lisata and WARPNINE, underscoring our shared dedication to advancing breakthrough therapies for gastrointestinal solid tumors,” said Kristen K. Buck, MD, Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “It is especially important to note that this is the first study in which we are evaluating locally advanced non-resectable PDAC, an earlier stage in the disease process than metastatic PDAC. Immunotherapy has largely been ineffective in this patient population, and thus, we were encouraged by the preliminary data presented this year at ASCO-GI, followed by updated preliminary data presented earlier this month at ESMO-GI. We are hopeful that final data from the study will be equally encouraging.”
The Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic iLSTA trial is being conducted at St John of God Subiaco Hospital in Western Australia, a leading center for clinical research and innovation with a proven track record in early drug development research. The study is evaluating certepetide in combination with SoC chemotherapy (nab-paclitaxel and gemcitabine) plus SoC immunotherapy (durvalumab), compared to SoC alone, in patients with locally advanced, unresectable PDAC. This collaboration exemplifies the power of uniting global expertise with local excellence to meet the urgent needs of people with pancreatic cancer. It brings together drug supply and clinical strategy from Lisata, drug supply from AstraZeneca, and operational execution and funding support from WARPNINE. Participants in the iLSTA trial were divided into three treatment cohorts (1:1:4 ratio): Cohort 1 (n=5) received SoC chemotherapy in combination with placebo durvalumab and placebo certepetide. Cohort 2 (n=5) received SoC chemotherapy plus certepetide and placebo durvalumab. Cohort 3 (n=20) received SoC chemotherapy plus durvalumab and certepetide.
The updated preliminary data from the iLSTA trial, presented at the 2025 ESMO Gastrointestinal Cancers (ESMO-GI) Congress on July 3, 2025, demonstrated an overall response rate of 60% and an overall disease control rate of 100%. After 4 treatment cycles, 13/20 participants showed a RECIST partial response (11 patients in Cohort 3), and 1 participant (Cohort 2) exhibited a RECIST complete response. The remaining 6 participants demonstrated stable disease (<22.0% decrease in tumor size). No participant showed an increase in tumor size. Additionally, 16/20 participants experienced a decrease in CA19-9 levels, with 7 participants showing a >90% reduction (5 patients in Cohort 3) and 9 participants showing a >50% reduction in CA19-9 levels (6 patients in Cohort 3). For a detailed summary of the poster presentation, please see the abstract available on the ESMO-GI website: https://cslide.ctimeetingtech.com/coasis_21393/attendee/confcal_1/presentation/list?q=lsta-1.
“We are delighted to have completed enrollment in the iLSTA trial. This achievement not only reflects the dedication of our team and collaborators at St John of God Subiaco Hospital, but also brings us closer to potentially offering a new, much-needed treatment option for patients battling locally advanced PDAC,” said Meg Croucher, Chief Executive Officer of WARPNINE. “Given the highly promising preliminary data presented at ESMO-GI, which highlighted a 60% overall response rate and 100% overall disease control rate, we are even more optimistic about the potential impact of this therapy. We look forward to analyzing the final data from the study and continuing our work to bring more effective treatments to those who need them most.”
Certepetide (formerly LSTA1), an internalizing RGD (arginyl-glycyl-aspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and 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 been shown 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 cyclic peptide product candidate, certepetide, 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 1.5 years and believes that its projected capital will fund operations into the fourth quarter of 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. For a comprehensive overview of certepetide’s mechanism of action, please view our informative short film. For more information, visit www.lisata.com.
WARPNINE is Western Australia’s research into pancreatic, gastro-intestinal, and rare cancers. Established by a group of leading cancer specialists, WARPNINE seeks to address the inequity in cancer outcomes for what are essentially underfunded and under-researched malignancies. We are committed to providing real and meaningful benefit to patients, while building on Western Australia’s best-in-the-world outcomes for these cancers. For more information, visit www.warpnine.org.au.
St John of God Subiaco Hospital was founded in 1898 by the Sisters of St John of God during the Western Australian Gold Rush of the 1890’s. The hospital is one the leading private hospitals in Australia providing oncology, surgery, obstetrics and gynecology services. The clinical trials unit is one of the busiest in the country currently with 58 open trials and numerous publications from the extensive research carried out at the hospital. The hospital has 578 beds and 20 operating theatres.
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