Lisata Therapeutics and WARPNINE Announce Encouraging Preliminary Results from the Phase 1b/2a iLSTA Trial Evaluating Certepetide in Locally Advanced Non-Resectable Pancreatic Ductal Adenocarcinoma
Lisata Therapeutics (NASDAQ: LSTA) and WARPNINE announced encouraging preliminary results from their Phase 1b/2a iLSTA trial evaluating certepetide in combination with standard-of-care (SoC) chemotherapy and immunotherapy for locally advanced non-resectable pancreatic ductal adenocarcinoma (PDAC).
The trial, conducted at St John of God Subiaco Hospital, involved 30 patients in three cohorts. Key preliminary results from 17 patients showed:
- 9 of 16 patients achieved partial response after 4 treatment cycles
- 1 patient exhibited complete response
- 14 of 17 patients showed decreased CA19-9 levels, with 6 patients showing >90% reduction
- All 5 analyzed patients showed significant immune cell infiltration (15% to 50%)
The data suggests certepetide's potential to enhance the effectiveness of various cancer treatments when combined with SoC chemotherapy and immunotherapy.
Lisata Therapeutics (NASDAQ: LSTA) e WARPNINE hanno annunciato risultati preliminari incoraggianti dal loro trial di Fase 1b/2a iLSTA che valuta certepetide in combinazione con la chemioterapia e l'immunoterapia standard (SoC) per l'adencarcinoma duttale pancreatico non resecabile localmente (PDAC).
Il trial, condotto presso l'ospedale St John of God a Subiaco, ha coinvolto 30 pazienti suddivisi in tre coorti. I principali risultati preliminari provenienti da 17 pazienti hanno mostrato:
- 9 dei 16 pazienti hanno raggiunto una risposta parziale dopo 4 cicli di trattamento
- 1 paziente ha mostrato una risposta completa
- 14 dei 17 pazienti hanno mostrato una diminuzione dei livelli di CA19-9, con 6 pazienti che hanno mostrato una riduzione superiore al 90%
- Tutti e 5 i pazienti analizzati hanno mostrato un'infiltrazione significativa di cellule immunitarie (dal 15% al 50%)
I dati suggeriscono il potenziale di certepetide di migliorare l'efficacia di vari trattamenti oncologici quando combinato con la chemioterapia e l'immunoterapia standard (SoC).
Lisata Therapeutics (NASDAQ: LSTA) y WARPNINE anunciaron resultados preliminares alentadores de su ensayo de Fase 1b/2a iLSTA que evalúa certepetide en combinación con la quimioterapia y la inmunoterapia estándar (SoC) para el adenocarcinoma ductal pancreático no resecable localmente (PDAC).
El ensayo, realizado en el hospital St John of God en Subiaco, involucró a 30 pacientes en tres cohortes. Los resultados preliminares clave de 17 pacientes mostraron:
- 9 de 16 pacientes alcanzaron una respuesta parcial después de 4 ciclos de tratamiento
- 1 paciente mostró respuesta completa
- 14 de 17 pacientes mostraron niveles disminuidos de CA19-9, con 6 pacientes mostrando una reducción >90%
- Los 5 pacientes analizados mostraron una infiltración significativa de células inmunitarias (15% a 50%)
Los datos sugieren el potencial de certepetide para mejorar la efectividad de varios tratamientos contra el cáncer cuando se combina con la quimioterapia y la inmunoterapia estándar (SoC).
리사타 테라퓨틱스 (NASDAQ: LSTA)와 WARPNINE은 세르테페타이드와 표준 치료(SoC) 화학요법 및 면역요법을 병용하여 국소 진행성 절제 불가능한 췌장 관세포선암(PDAC)을 평가하는 1b/2a 임상 시험인 iLSTA의 초기 결과를 발표했습니다.
이번 시험은 수비아코의 St John of God 병원에서 실시되었으며, 30명의 환자가 3개 코호트로 나뉘어 포함되었습니다. 17명의 환자로부터 나온 주요 초기 결과는 다음과 같습니다:
- 16명 중 9명이 4번의 치료 주기 후 부분 반응을 보였습니다
- 1명은 완전 반응을 보였습니다
- 17명 중 14명의 환자가 CA19-9 수치가 감소했으며, 6명은 90% 이상 감소를 보였습니다
- 분석된 5명의 환자 모두 면역 세포 침윤이 유의미하게 나타났습니다 (15%에서 50%까지)
이 데이터는 세르테페타이드가 SoC 화학요법 및 면역요법과 결합할 때 여러 암 치료의 효과를 높일 수 있는 가능성을 시사합니다.
Lisata Therapeutics (NASDAQ: LSTA) et WARPNINE ont annoncé des résultats préliminaires encourageants de leur essai de phase 1b/2a iLSTA évaluant certepetide en combinaison avec la chimiothérapie de référence (SoC) et l'immunothérapie pour l'adénocarcinome canalaire pancréatique avancé non résécable (PDAC).
L'essai, mené à l'hôpital St John of God à Subiaco, a impliqué 30 patients répartis en trois cohortes. Les résultats préliminaires clés de 17 patients ont montré:
- 9 des 16 patients ont atteint une réponse partielle après 4 cycles de traitement
- 1 patient a présenté une réponse complète
- 14 des 17 patients ont montré une diminution des niveaux de CA19-9, dont 6 patients affichant une réduction >90%
- Les 5 patients analysés ont montré une infiltration cellulaire immunitaire significative (de 15% à 50%)
Les données suggèrent que certepetide a le potentiel d'améliorer l'efficacité de divers traitements contre le cancer lorsqu'il est combiné avec la chimiothérapie et l'immunothérapie standard (SoC).
Lisata Therapeutics (NASDAQ: LSTA) und WARPNINE haben ermutigende vorläufige Ergebnisse aus ihrer Phase 1b/2a iLSTA-Studie bekannt gegeben, die certepetide in Kombination mit der Standardtherapie (SoC) Chemotherapie und Immuntherapie bei lokal fortgeschrittenem, nicht resezierbarem duktalem Pankreasadenokarzinom (PDAC) bewertet.
Die Studie, die im St John of God Krankenhaus in Subiaco durchgeführt wurde, umfasste 30 Patienten in drei Kohorten. Die wichtigsten vorläufigen Ergebnisse von 17 Patienten zeigten:
- 9 von 16 Patienten erreichten nach 4 Behandlungszyklen eine partielle Reaktion
- 1 Patient zeigte eine vollständige Reaktion
- 14 von 17 Patienten zeigten gesunkene CA19-9-Spiegel, wobei 6 Patienten eine Reduktion von >90% zeigten
- Alle 5 analysierten Patienten zeigten eine signifikante Infiltration von Immunzellen (15% bis 50%)
Die Daten deuten darauf hin, dass certepetide das Potenzial hat, die Wirksamkeit verschiedener Krebsbehandlungen zu verbessern, wenn es mit der SoC-Chemotherapie und Immuntherapie kombiniert wird.
- High response rate with 9 of 16 patients achieving partial response and 1 complete response
- Strong CA19-9 level reduction in 14 of 17 patients, with 6 showing >90% decrease
- Significant immune cell infiltration observed in all analyzed patients
- Preliminary data validates certepetide's mechanism of action
- None.
Insights
The preliminary results from the iLSTA trial represent a potentially significant breakthrough in PDAC treatment, a notoriously aggressive cancer with historically poor outcomes. The data is particularly noteworthy for several reasons:
Key Clinical Outcomes:
- The 56.25% partial response rate (9/16 patients) after 4 cycles represents a marked improvement over typical response rates for standard treatments
- The observation of one complete response is especially significant given PDAC's resistance to most therapies
- The CA19-9 biomarker reductions (>90% in 6 patients, >50% in 8 patients) suggest robust anti-tumor activity
The increased tumor-infiltrating lymphocytes (15-50% stroma infiltration) are particularly significant as PDAC typically presents with an immunosuppressive microenvironment that limits immunotherapy effectiveness. This suggests certepetide may be successfully modifying the tumor microenvironment to enable better treatment penetration.
While these results are preliminary, they indicate potential for certepetide to address one of PDAC's fundamental challenges - the dense stroma that typically blocks drug delivery. The consistent positive results in Cohort 3 (full combination therapy) suggest synergistic effects that could lead to improved treatment paradigms for this difficult-to-treat cancer.
These preliminary results could substantially strengthen Lisata's position in the $4+ billion pancreatic cancer treatment market. The data is particularly valuable for several reasons:
- The combination therapy approach with standard-of-care treatments could accelerate market adoption if approved
- Strong efficacy signals in locally advanced non-resectable PDAC could position certepetide as a key component of first-line treatment
- The collaboration with WARPNINE demonstrates efficient clinical development strategy, potentially reducing development costs
The biomarker data and response rates exceed typical expectations for PDAC treatments, which could support accelerated development pathways. For a company with a market cap of
The trial's progression and positive preliminary results may attract attention from larger pharmaceutical companies, potentially leading to partnership opportunities or licensing deals. The data's quality and the targeted approach to a difficult-to-treat cancer type position Lisata favorably for future development stages.
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 >
“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, M.D., 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,” stated 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.”
About Certepetide
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.).
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 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 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.
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 metastatic pancreatic ductal adenocarcinoma and other 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 a single patient case study 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 29, 2024, 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
m: 0406 818 810
e: meg@warpnine.org.au
www.warpnine.org.au
This press release was published by a CLEAR® Verified individual.
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