Lisata Therapeutics & WARPNINE Announce Encouraging Preliminary Results From Phase 1b/2a iLSTA Trial

Lisata Therapeutics, Inc. and WARPNINE Incorporated recently announced encouraging preliminary results from the Phase 1b/2a iLSTA trial (ACTRN12623000223639) evaluating certepetide (formerly LSTA1), Lisata’s proprietary investigational 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). The preliminary data will be presented in a poster session titled Immunotherapy combined with a novel iRGD peptide plus nab-paclitaxel and gemcitabine for locally advanced pancreatic ductal adenocarcinoma: A prospective study, at the 2025 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium on Friday, January 24, 2025 at 11:30 a.m. – 1:00 p.m. (PST) in San Franscisco, California. For a detailed summary of the poster presentation, please see the abstract available on the ASCO GI website: https://meetings.asco.org/abstracts-presentations/241611.

The Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic iLSTA trial, being conducted at St John of God Subiaco Hospital in Western Australia, a leading center for clinical research and innovation, is evaluating certepetide in combination with SoC chemotherapy (nab-paclitaxel and gemcitabine) plus SoC immunotherapy (durvalumab) versus SoC alone in patients with locally advanced non-resectable PDAC. This collaboration highlights the strength of combining global expertise with local excellence to address the urgent needs of patients with pancreatic cancer. 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 preliminary results, representing an interim analysis of the first 17 of 30 targeted patients of the iLSTA trial are as follows:

Five of 16 patients evaluable by RECIST criteria experienced a partial response after 2 cycles of treatment (4 patients were in cohort 3), with the remaining 11 patients presenting with stable disease. After 4 cycles of treatment, 9 of 16 patients demonstrated partial response (8 patients were in cohort 3). Of the remaining 7 patients, 6 demonstrated stable disease, and 1 patient (cohort 2) exhibited a complete response. Fourteen of 17 patients who completed 4 treatment cycles showed a decrease in CA19-9 levels. Six patients demonstrated >90% reduction in CA19-9 (5 of whom in cohort 3), with the remaining 8 patients showing a >50% reduction in CA19-9 levels (6 of whom in cohort 3). Five patients had their repeat biopsies analyzed for tumor infiltrating lymphocytes (4 of whom from cohort 3), with all patients showing significant immune cell infiltration (15% to 50% stroma infiltration). These results demonstrate the potential value of adding certepetide to the SoC regimen consisting of gemcitabine, nab-paclitaxel, and durvalumab in this patient population.

“These initial results from the iLSTA trial suggest that certepetide, when combined with SoC chemotherapy and immunotherapy, can positively impact treatment outcomes for patients with locally advanced non-resectable PDAC,” stated Kristen K. Buck, MD, Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “This patient population has historically demonstrated limited response to immunotherapy alone. These encouraging findings not only validate certepetide’s unique mechanism of action but also support our hypothesis that it can enhance the effectiveness of various cancer treatments, regardless of the modality of the co-administered therapies. The results also reinforce certepetide’s potential to impact patients across the spectrum of pancreatic cancer.”

“The preliminary results from the iLSTA trial underscore the importance of collaborative efforts in addressing the unmet needs of patients with pancreatic cancer,” added Meg Croucher, Chief Executive Officer of WARPNINE. “At WARPNINE, we are dedicated to supporting innovative trials like iLSTA that push the boundaries of treatment possibilities and offer hope to those battling these aggressive malignancies. We look forward to continuing our work with Lisata Therapeutics to advance outcomes for patients.”

Certepetide (formerly LSTA1), an internalizing RGD (arginylglycylaspartic 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 (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).

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 early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. Learn more about certepetide’s mechanism of action in our 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.