Lisata Therapeutics and WARPNINE Announce iLSTA Trial Enrollment Completion and Provide Preliminary Data Update
Lisata Therapeutics (Nasdaq: LSTA) announced the completion of patient enrollment in their Phase 1b/2a iLSTA trial, evaluating certepetide in combination with standard-of-care chemotherapy and immunotherapy for locally advanced non-resectable pancreatic ductal adenocarcinoma (PDAC).
The trial's preliminary data, presented at ESMO-GI 2025, showed remarkable results: an overall response rate of 60% and a disease control rate of 100%. Of the 20 participants, 13 showed partial response, 1 exhibited complete response, and 6 demonstrated stable disease. Additionally, 16 out of 20 participants experienced decreased CA19-9 levels, with 7 showing >90% reduction.
The study, conducted at St John of God Subiaco Hospital in Australia, divided participants into three cohorts, with the largest group (Cohort 3, n=20) receiving the full combination therapy of chemotherapy, durvalumab, and certepetide.
Lisata Therapeutics (Nasdaq: LSTA) ha annunciato il completamento del reclutamento dei pazienti nello studio di Fase 1b/2a iLSTA, che valuta certepetide in combinazione con la chemioterapia standard e l'immunoterapia per l'adenocarcinoma duttale pancreatico localmente avanzato non resecabile (PDAC).
I dati preliminari dello studio, presentati all'ESMO-GI 2025, hanno mostrato risultati straordinari: un tasso di risposta globale del 60% e un tasso di controllo della malattia del 100%. Dei 20 partecipanti, 13 hanno mostrato una risposta parziale, 1 una risposta completa e 6 una malattia stabile. Inoltre, 16 su 20 partecipanti hanno registrato una diminuzione dei livelli di CA19-9, con 7 che hanno mostrato una riduzione superiore al 90%.
Lo studio, condotto presso l'Ospedale St John of God Subiaco in Australia, ha suddiviso i partecipanti in tre coorti, con il gruppo più numeroso (Coorte 3, n=20) che ha ricevuto la terapia combinata completa di chemioterapia, durvalumab e certepetide.
Lisata Therapeutics (Nasdaq: LSTA) anunció la finalización de la inscripción de pacientes en su ensayo de Fase 1b/2a iLSTA, que evalúa certepetide en combinación con quimioterapia estándar e inmunoterapia para el adenocarcinoma ductal pancreático localmente avanzado no resecable (PDAC).
Los datos preliminares del ensayo, presentados en ESMO-GI 2025, mostraron resultados notables: una tasa de respuesta global del 60% y una tasa de control de la enfermedad del 100%. De los 20 participantes, 13 mostraron respuesta parcial, 1 respuesta completa y 6 enfermedad estable. Además, 16 de los 20 participantes experimentaron una disminución en los niveles de CA19-9, con 7 mostrando una reducción superior al 90%.
El estudio, realizado en el Hospital St John of God Subiaco en Australia, dividió a los participantes en tres cohortes, siendo el grupo más grande (Cohorte 3, n=20) el que recibió la terapia combinada completa de quimioterapia, durvalumab y certepetide.
Lisata Therapeutics (나스닥: LSTA)가 국소 진행성 절제 불가능 췌장관 선암(PDAC)에 대해 표준 치료 화학요법 및 면역요법과 병용한 certepetide의 평가를 위한 1b/2a상 iLSTA 임상시험 환자 등록을 완료했다고 발표했습니다.
ESMO-GI 2025에서 발표된 예비 데이터는 놀라운 결과를 보여주었습니다: 전체 반응률 60% 및 질병 조절률 100%. 20명의 참가자 중 13명은 부분 반응, 1명은 완전 반응, 6명은 안정 질환을 나타냈습니다. 또한 20명 중 16명은 CA19-9 수치가 감소했으며, 7명은 90% 이상의 감소를 보였습니다.
호주 St John of God Subiaco 병원에서 진행된 본 연구는 참가자들을 세 개의 코호트로 나누었으며, 가장 큰 그룹인 코호트 3 (n=20)은 화학요법, durvalumab, 그리고 certepetide의 완전 병용 치료를 받았습니다.
Lisata Therapeutics (Nasdaq : LSTA) a annoncé la fin du recrutement des patients dans leur essai de phase 1b/2a iLSTA, évaluant certepetide en combinaison avec la chimiothérapie standard et l'immunothérapie pour l'adénocarcinome canalaire pancréatique localement avancé non résécable (PDAC).
Les données préliminaires de l'essai, présentées à l'ESMO-GI 2025, ont montré des résultats remarquables : un taux de réponse globale de 60% et un taux de contrôle de la maladie de 100%. Sur les 20 participants, 13 ont présenté une réponse partielle, 1 une réponse complète et 6 une maladie stable. De plus, 16 des 20 participants ont connu une diminution des niveaux de CA19-9, dont 7 avec une réduction supérieure à 90%.
L'étude, menée à l'hôpital St John of God Subiaco en Australie, a divisé les participants en trois cohortes, le groupe le plus important (Cohorte 3, n=20) recevant la thérapie combinée complète de chimiothérapie, durvalumab et certepetide.
Lisata Therapeutics (Nasdaq: LSTA) gab den Abschluss der Patienteneinschreibung in ihrer Phase 1b/2a iLSTA-Studie bekannt, die certepetide in Kombination mit Standard-Chemotherapie und Immuntherapie bei lokal fortgeschrittenem, nicht resezierbarem Pankreas duktalem Adenokarzinom (PDAC) untersucht.
Die vorläufigen Studiendaten, präsentiert auf der ESMO-GI 2025, zeigten bemerkenswerte Ergebnisse: eine Gesamtansprechrate von 60% und eine Krankheitskontrollrate von 100%. Von 20 Teilnehmern zeigten 13 eine partielle Remission, 1 eine komplette Remission und 6 eine stabile Erkrankung. Zudem erfuhren 16 von 20 Teilnehmern eine Abnahme der CA19-9-Werte, wobei 7 eine Reduktion von über 90% zeigten.
Die Studie, durchgeführt im St John of God Subiaco Hospital in Australien, teilte die Teilnehmer in drei Kohorten auf, wobei die größte Gruppe (Kohorte 3, n=20) die vollständige Kombinationstherapie aus Chemotherapie, Durvalumab und Certepetide erhielt.
- Strong preliminary efficacy with 60% overall response rate and 100% disease control rate
- 16 out of 20 participants showed decreased CA19-9 cancer markers
- No participants showed tumor size increase during treatment
- First study evaluating treatment for earlier-stage locally advanced PDAC
- Small trial size with only 30 total participants across all cohorts
- Results are preliminary and final data analysis is still pending
Insights
Lisata's pancreatic cancer trial shows promising 60% response rate with certepetide combination therapy, potentially addressing a significant treatment gap.
The completion of enrollment in Lisata's Phase 1b/2a iLSTA trial represents a significant milestone in the development of certepetide (formerly LSTA1) for locally advanced non-resectable pancreatic ductal adenocarcinoma (PDAC). This is particularly noteworthy as it targets an earlier disease stage than metastatic PDAC, where treatment options remain limited and survival rates are dismal.
The preliminary data is genuinely encouraging. The trial showed an overall response rate of 60% and a disease control rate of 100%, which are impressive metrics for pancreatic cancer. Breaking this down: 13 participants demonstrated partial responses, 1 achieved a complete response, and 6 showed stable disease. Most significantly, no patients exhibited tumor growth during the evaluation period.
The CA19-9 biomarker reductions provide further evidence of biological activity - 7 patients showing >90% reduction and 9 patients with >50% reduction. CA19-9 is an important serum marker in pancreatic cancer that correlates with tumor burden and treatment response.
Looking at the trial design, the 1:1:4 randomization ratio appropriately emphasizes the triple combination arm (Cohort 3: chemotherapy + durvalumab + certepetide), which showed the strongest signals with 11/20 partial responses. This suggests potential synergy between certepetide and immunotherapy, which aligns with the mechanistic hypothesis that certepetide may enhance drug delivery and immune cell infiltration into the tumor microenvironment.
While these results are promising, several questions remain: durability of response, progression-free survival, and overall survival data will be critical. Additionally, the sample size is small (30 patients total), and single-center studies can sometimes show stronger results than multi-center trials. A larger Phase 2/3 study will be necessary to confirm these findings.
Compelling new preliminary data consistent with previously reported preclinical findings demonstrating certepetide’s potential ability to enhance the effectiveness of immunotherapy
BASKING RIDGE, N.J. and SUBIACO, Australia, July 17, 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 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,” stated Kristen K. Buck, M.D., 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
“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,” stated Meg Croucher, Chief Executive Officer of WARPNINE. “Given the highly promising preliminary data presented at ESMO-GI, which highlighted a
About Certepetide
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 (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.).
About Lisata Therapeutics
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 on the Company, please visit www.lisata.com.
About WARPNINE Incorporated
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 on WARPNINE, please visit www.warpnine.org.au.
About St John of God Subiaco Hospital
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.
Forward-Looking Statements
This communication contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding the Company’s clinical development programs are forward-looking statements. In addition, when or if used in this communication, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Lisata or its management, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the potential efficacy of certepetide as a treatment for patients with solid tumors; our beliefs about the potential uses and benefits of certepetide; statements relating to Lisata’s continued listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of Lisata; the approach Lisata is taking to discover and develop novel therapeutics; the adequacy of Lisata’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; and the difficulty in predicting the time and cost of development of Lisata’s product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: results observed from preliminary data are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the safety and efficacy of Lisata’s product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in Lisata’s clinical programs, Lisata’s ability to finance its operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of Lisata’s scientific studies, Lisata’s ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in Lisata’s markets, the ability of Lisata to protect its intellectual property rights; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Lisata’s Annual Report on Form 10-K filed with the SEC on February 27, 2025, and in other documents filed by Lisata with the Securities and Exchange Commission. Except as required by applicable law, Lisata undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events, or otherwise.
Lisata Therapeutics Contact:
Investors:
Lisata Therapeutics
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@lisata.com
Media:
ICR Healthcare
Elizabeth Coleman
Account Supervisor
Phone: 203-682-4783
Email: elizabeth.coleman@icrhealthcare.com
WARPNINE Contact:
WARPNINE Incorporated:
Meg Croucher
Chief Executive Officer
Phone: 0406 818 810
Email: meg@warpnine.org.au
www.warpnine.org.au
This press release was published by a CLEAR® Verified individual.
FAQ
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