Lisata Therapeutics Announces Encouraging Preliminary Results from the Pancreatic Cancer Cohort of the CENDIFOX Trial
Lisata Therapeutics (Nasdaq: LSTA) reported encouraging preliminary results from the pancreatic cancer (PDAC) cohort of its Phase 1/2a CENDIFOX trial, evaluating certepetide in combination with FOLFIRINOX-based therapies. The trial, led by Dr. Anup Kasi at KU Cancer Center, showed promising outcomes in treating resectable and borderline resectable PDAC.
Key findings from the 35-patient PDAC cohort include: 50% R0 resection rate and 70% pathologic partial response among the 10 patients who completed pre-surgical therapy. The study demonstrated a 60% two-year overall survival rate and 12-month median disease-free survival. Importantly, the combination therapy showed enhanced immune cell infiltration and increased expression of immune markers, suggesting potential transformation of pancreatic tumors from "immune-cold" to "immune-hot."
Lisata Therapeutics (Nasdaq: LSTA) ha riportato risultati preliminari incoraggianti dalla coorte PDAC dello studio di fase 1/2a CENDIFOX, che valuta certepetide in combinazione con terapie basate su FOLFIRINOX. Il trial, guidato dal Dr. Anup Kasi presso il KU Cancer Center, ha mostrato esiti promettenti nel trattamento di PDAC resecabile e borderline resecabile.
I principali risultati della coorte PDAC di 35 pazienti includono: tasso di resezione R0 del 50% e risposta patologica parziale del 70% tra i 10 pazienti che hanno completato la terapia pre-operatoria. Lo studio ha evidenziato una survival globale a due anni del 60% e una mediana di disease-free survival di 12 mesi. Importante, la terapia combinata ha mostrato una maggiore infiltrazione delle cellule immunitarie e un aumento dell’espressione di marcatori immunitari, suggerendo una potenziale trasformazione dei tumori pancreatici da “immune-cold” a “immune-hot”.
Lisata Therapeutics (Nasdaq: LSTA) informó resultados preliminares alentadores de la cohorte de cáncer de páncreas (PDAC) del ensayo CENDIFOX de fase 1/2a, que evalúa certepetide en combinación con terapias basadas en FOLFIRINOX. El ensayo, dirigido por el Dr. Anup Kasi en el KU Cancer Center, mostró resultados prometedores en PDAC resecable y borderline resecable.
Hallazgos clave de la cohorte PDAC de 35 pacientes incluyen: tasa de resección R0 del 50% y respuesta patológica parcial del 70% entre los 10 pacientes que completaron la terapia prequirúrgica. El estudio mostró una supervivencia global a dos años del 60% y una mediana de disease-free survival de 12 meses. Importante, la terapia combinada mostró una mayor infiltración de células inmunes y mayor expresión de marcadores inmunitarios, lo que sugiere una posible transformación de tumores pancreáticos de “frío” a “caliente” desde el punto de vista inmunológico.
Lisata Therapeutics (Nasdaq: LSTA)는 FOLFIRINOX 기반 치료와 함께 certepetide를 평가하는 1/2a상 CENDIFOX 시험의 췌장암(PDAC) 코호트에서 고무적인 예비 결과를 보고했습니다. KU Cancer Center의 Anup Kasi 박사가 이끄는 이 연구는 재수술 가능성(PDAC 재섹션 가능) 및 경계 재섹션 가능성의 PDAC 치료에서 유망한 결과를 보였습니다.
35명의 PDAC 코호트의 주요 결과에는 50%의 R0 절제율과 절제 전 치료를 완료한 10명 중 70%의 병리학적 부분 반응, 2년 overall survival 60%, 병이 없는 상태의 중앙값 12개월이 포함됩니다. 특히, 병용 요법은 면역 세포 침윤을 증가시키고 면역 마커의 발현을 증가시켜 췌장 종양을 '면역-콜드'에서 '면역-핫'으로 전환시킬 가능성을 시사합니다.
Lisata Therapeutics (Nasdaq : LSTA) a publié des résultats préliminaires encourageants sur la cohorte PDAC (cancer du pancréas) de son essai CENDIFOX de phase 1/2a, évaluant la certepetide en association avec des thérapies à base de FOLFIRINOX. L’essai, dirigé par le Dr Anup Kasi au KU Cancer Center, a montré des résultats prometteurs dans le traitement des PDAC résécables et borderline résécables.
Les résultats clés de la cohorte PDAC de 35 patients comprennent : un taux de résection R0 de 50 % et une réponse pathologique partielle de 70 % chez les 10 patients ayant terminé la thérapie préopératoire. L’étude a démontré une survie globale à deux ans de 60 % et une médiane de disease-free survival de 12 mois. Fait important, la thérapie combinée a montré une infiltration accrue des cellules immunitaires et une expression accrue des marqueurs immunitaires, suggérant une potentielle transformation des tumeurs pancréatiques de « froides » à « chaudes » du point de vue immunitaire.
Lisata Therapeutics (Nasdaq: LSTA) hat ermutigende vorläufige Ergebnisse aus der PDAC-Kohorte des Phase-1/2a-CENDIFOX-Studienprogramms berichtet, in dem Certetipide in Kombination mit auf FOLFIRINOX basierenden Therapien bewertet wird. Die von Dr. Anup Kasi am KU Cancer Center geleitete Studie zeigte vielversprechende Ergebnisse bei resektablen und borderline resektablen PDAC.
Wichtige Befunde der 35-Patienten-PDAC-Kohorte schließen ein: 50%-R0-Resektionsrate und 70%-pathologische Teilansprechen bei den 10 Patienten, die die vorgeschriebene präoperative Therapie abgeschlossen hatten. Die Studie wies eine 60%-Zwei-Jahres-Überlebensrate und eine Median-krankheitsfreier Überleben von 12 Monaten auf. Wichtig ist, dass die Kombinationstherapie eine erhöhte Immunzell-Infiltration und eine gesteigerte Expression von Immunmarkern zeigte, was auf eine potenzielle Umwandlung von pankreatischen Tumoren von „immune-cold“ zu „immune-hot“ hindeutet.
Lisata Therapeutics (Nasdaq: LSTA) أبلغت عن نتائج تمهيدية مشجعة من cohorte PDAC لتجربة CENDIFOX من المرحلة 1/2a، التي تقيم certepetide بالاشتراك مع علاجات قائمة على FOLFIRINOX. التجربة بقيادة الدكتور أنوب كاسي في KU Cancer Center أظهرت نتائج واعدة في علاج PDAC القابل للإزالة وال PDAC الحدودي القابل للإزالة.
تشمل النتائج الرئيسية من كوهرته PDAC المكونة من 35 مريضاً: معدل الاستئصال R0 بنسبة 50% و استجابة مرضية جزئية بنسبة 70% بين 10 مرضى أكملوا العلاج قبل الجراحة. أظهرت الدراسة وجود بقاء على قيد الحياة العام لمدة سنتين بمقدار 60% ومدة بقـاء خالية من المرض بمتوسط 12 شهراً. من المهم أن العلاج المركب أظهر زيادة في اختراق الخلايا المناعية وزيادة في تعبير العلامات المناعية، مما يشير إلى احتمال تحويل أورام البنكرياس من "باردة مناعياً" إلى "حارة مناعياً".
Lisata Therapeutics (Nasdaq: LSTA) 公布其1/2a阶段CENDIFOX试验的胰腺癌（PDAC）队列初步结果，评估 certepetide 与基于 FOLFIRINOX 的治疗联合使用。该试验由 KU Cancer Center 的 Anup Kasi 博士领导，在可切除和边缘可切除的 PDAC 治疗中显示出有希望的结果。
来自35名 PDAC 队列的关键发现包括：R0 切除率 50%，在完成围手术前治疗的 10 名患者中有 病理学部分缓解率 70%。研究显示两年总生存率为 60%，无疾病生存中位数为 12 个月。重要的是，联合治疗显示免疫细胞浸润增加、免疫标志物表达上升，提示胰腺肿瘤可能从“免疫冷”转变为“免疫热”。
- Achieved 50% R0 resection rate and 70% pathologic partial response in eligible patients
- Demonstrated promising 60% two-year overall survival rate
- No serious adverse events attributed to certepetide, showing favorable safety profile
- Enhanced immune cell infiltration and increased immune markers expression, suggesting improved immunotherapy potential
- Only 10 out of 35 enrolled patients completed pre-surgical therapy and were eligible for resection
- Limited sample size may affect statistical significance of results
Insights
Lisata's certepetide shows promising preliminary data in pancreatic cancer with improved surgical outcomes and potential immunomodulatory effects.
The preliminary results from Lisata's CENDIFOX trial represent a meaningful development in the challenging landscape of pancreatic cancer treatment. The trial evaluates certepetide (an iRGD cyclic peptide) in combination with FOLFIRINOX in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma (PDAC).
The data reveals several promising findings: among the 10 evaluable patients who completed pre-surgical therapy, 50% achieved R0 resection (complete removal of cancer with no cancer cells at the surgical margins) and 70% demonstrated pathologic partial response. These are noteworthy outcomes in pancreatic cancer, where complete resections are often difficult to achieve due to the infiltrative nature of the disease.
The early survival data is particularly encouraging with a 60% two-year overall survival rate and 12-month median disease-free survival. For context, pancreatic cancer typically has a dismal prognosis with only 13% five-year survival rate as mentioned in the release.
Perhaps most intriguing is the evidence that certepetide may transform pancreatic tumors from "immune-cold" to "immune-hot" based on increased immune cell infiltration and upregulation of immune markers (CD68, PD-1, PD-L1). This mechanism could potentially overcome one of the major barriers in pancreatic cancer treatment - its notorious resistance to immunotherapies due to an immunosuppressive microenvironment.
The safety profile appears favorable with no serious adverse events attributed to certepetide, which is crucial for a combination therapy approach. While these results are preliminary from a small subset of patients (10 out of 35 enrolled), they provide a signal that certepetide's approach of enhancing drug delivery and modulating the tumor microenvironment may offer a novel strategy in a disease with limited effective options.
Results to be presented at the AACR Special Conference in Cancer Research: Advances in Pancreatic Cancer Research—Emerging Science Driving Transformative Solutions
BASKING RIDGE, N.J., Sept. 29, 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, today announced encouraging preliminary data from the pancreatic ductal adenocarcinoma (“PDAC”) cohort of the Phase 1/2a CENDIFOX trial (NCT05121038). The investigator-initiated trial, led by Anup Kasi, M.D., M.P.H., at The University of Kansas (“KU”) Cancer Center, is evaluating Lisata's proprietary investigational iRGD cyclic peptide product candidate, certepetide, in combination with FOLFIRINOX-based therapies for the treatment of pancreatic, colon, and appendiceal cancers.
The preliminary data will be presented in poster A070, titled “CENDIFOX: Phase I/II Trial of CEND-1 (LSTA1, certepetide) with Neoadjuvant mFOLFIRINOX in Resectable and Borderline Resectable PDAC,” at the American Association for Cancer Research (“AACR”) Special Conference in Cancer Research: Advances in Pancreatic Cancer Research—Emerging Science Driving Transformative Solutions on September 29, 2025, from 4:30 p.m. - 7:00 p.m. in Boston, Massachusetts. The poster presentation will highlight findings from patients with resectable and borderline resectable PDAC, with the full abstract available on the AACR website.
“The preliminary trial data has been very promising, and we’re excited to share these findings with the broader oncology community,” stated Dr. Anup Kasi. “The ability of certepetide to improve drug delivery and influence the tumor microenvironment may offer a potential new and exciting treatment approach for pancreatic cancer. We are optimistic studies like CENDIFOX will pave the way for more effective combination therapies for difficult-to-treat solid tumor cancers.”
“The initial results from the CENDIFOX trial are very encouraging, showing that certepetide can enhance the effectiveness of standard-of-care chemotherapy in pancreatic cancer,” stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “We believe these findings are a significant step forward in a disease with few beneficial treatment options. By improving drug delivery and modulating the tumor microenvironment to re-engage the immune system, we see a path forward for this program and the potential to change the outlook for patients.”
The abstract highlights that the combination of certepetide with FOLFIRINOX was safe and feasible in patients with resectable and borderline resectable PDAC, with no serious adverse events attributed to certepetide. Among the 35 patients enrolled in the PDAC cohort, 10 completed the protocol-prescribed pre-surgical courses of therapy and were eligible to undergo pancreatic cancer resection. Based on these 10 patients, the R0 resection rate (no residual cancer at the surgical margins) was
Pancreatic cancer has one of the poorest prognoses among cancers, ranking as the 6th leading cause of cancer mortality worldwide1. With a five-year survival rate of just
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 The University of Kansas Cancer Center
The University of Kansas Cancer Center is transforming cancer research and clinical care by linking an innovative approach to drug discovery, delivery and development to a nationally accredited patient care program. Our consortium center includes cancer research and health care professionals associated with the University of Kansas Medical Center and The University of Kansas Health System; the University of Kansas, Lawrence; The Stowers Institute for Medical Research; Children’s Mercy; and in partnership with members of the Masonic Cancer Alliance.
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; the potential of the collaboration with Catalent to develop new treatment options; the expected expiration of our patents for certepetide; our ability to obtain patent term extension on our U.S. composition of matter patent; 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
University of Kansas Cancer Center Contact:
Media:
Kay Hawes
Associate Director of News and Media Relations
khawes@kumc.edu
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1 Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229–63.
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