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Data corroborate previously reported preclinical data demonstrating certepetide's ability to enhance the effectiveness of immunotherapy
Preliminary results to be presented at the 2025 ASCO Gastrointestinal Cancers Symposium
BASKING RIDGE, N.J. and SUBIACO, Australia, Jan. 23, 2025 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (NASDAQ:LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, and WARPNINE Incorporated ("WARPNINE"), Western Australia's first not-for-profit clinical research organization for pancreatic, gastro-intestinal and rare cancers, today 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, entitled, "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.
Posted In: LSTA
