Lisata Therapeutics Announces Completion of Enrollment in the CENDIFOX Trial
Lisata Therapeutics (LSTA) announced completion of patient enrollment in all three cohorts of the Phase 1b/2a CENDIFOX trial, evaluating certepetide in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers. The investigator-initiated trial, led by Dr. Anup Kasi at The University of Kansas Cancer Center, enrolled 66 total patients across three cohorts: 35 with resectable/borderline resectable pancreatic cancer, 18 with high-grade colon and appendiceal cancer with peritoneal metastasis, and 13 with colon cancer with oligo-metastatic disease.
The open-label trial aims to assess safety and therapeutic effects of combining certepetide with neoadjuvant FOLFIRINOX regimens. Results are expected in 2025. The study will provide pre- and post-treatment tumor tissue data for immune profiling and long-term patient outcomes information.
Lisata Therapeutics (LSTA) ha annunciato il completamento dell'arruolamento dei pazienti in tutte e tre le coorti dello studio clinico di Fase 1b/2a CENDIFOX, che valuta l'uso del certepetide in combinazione con terapie basate su FOLFIRINOX per i tumori del pancreas, del colon e dell'appendice. Lo studio, avviato dai ricercatori e guidato dal Dr. Anup Kasi presso The University of Kansas Cancer Center, ha arruolato 66 pazienti totali suddivisi in tre coorti: 35 con tumore pancreatico resecabile o borderline, 18 con tumore del colon e dell'appendice di alto grado con metastasi peritoneale, e 13 con tumore del colon con malattia oligo-metastatica.
Lo studio in aperto punta a valutare la sicurezza e gli effetti terapeutici della combinazione di certepetide con i regimi neoadiuvanti FOLFIRINOX. I risultati sono attesi nel 2025. Lo studio fornirà dati sui tessuti tumorali pre e post-trattamento per il profilo immunitario e informazioni sugli esiti a lungo termine dei pazienti.
Lisata Therapeutics (LSTA) anunció la finalización de la inclusión de pacientes en las tres cohortes del ensayo clínico de Fase 1b/2a CENDIFOX, que evalúa el certepetide en combinación con terapias basadas en FOLFIRINOX para cánceres de páncreas, colon y apéndice. El ensayo, iniciado por investigadores y dirigido por el Dr. Anup Kasi en el Centro de Cáncer de la Universidad de Kansas, incluyó 66 pacientes en total distribuidos en tres cohortes: 35 con cáncer de páncreas resecable o borderline, 18 con cáncer de colon y apéndice de alto grado con metástasis peritoneal y 13 con cáncer de colon con enfermedad oligo-metastásica.
El ensayo abierto tiene como objetivo evaluar la seguridad y los efectos terapéuticos de combinar certepetide con regímenes neoadyuvantes de FOLFIRINOX. Se esperan resultados en 2025. El estudio proporcionará datos de tejido tumoral pre y post-tratamiento para el perfil inmunológico y la información sobre los resultados a largo plazo de los pacientes.
리사타 테라퓨틱스 (LSTA)는 췌장, 대장 및 충수암의 FOLFIRINOX 기반 요법과 함께 certepetide를 평가하는 1b/2a 단계 CENDIFOX 시험의 세 가지 코호트에서 환자 등록이 완료되었음을 발표했습니다. 캔자스 대학교 암 센터의 Anup Kasi 박사가 이끄는 연구자 주도 시험은 총 66명의 환자를 세 가지 코호트로 등록했습니다: 절제 가능한/경계 절제 가능한 췌장암 35명, 복막 전이와 함께 고등급 대장 및 충수암 18명, 그리고 병소 전이가 있는 대장암 13명.
이 공개 라벨 시험은 neoadjuvant FOLFIRINOX 요법과 certepetide의 조합의 안전성과 치료 효과를 평가하는 것을 목표로 합니다. 결과는 2025년에 예상됩니다. 이 연구는 면역 프로파일링 및 장기 환자 결과 정보를 위한 치료 전후 종양 조직 데이터를 제공할 것입니다.
Lisata Therapeutics (LSTA) a annoncé l'achèvement de l'inscription des patients dans les trois cohortes de l'essai de Phase 1b/2a CENDIFOX, qui évalue le certepetide en combinaison avec des thérapies basées sur FOLFIRINOX pour les cancers du pancréas, du côlon et de l'appendice. L'essai, initié par des chercheurs et dirigé par le Dr Anup Kasi au Centre du cancer de l'Université du Kansas, a inclus 66 patients au total répartis dans trois cohortes : 35 présentant un cancer du pancréas résécable ou borderline, 18 avec cancer du côlon et de l'appendice de haut grade avec métastases péritonéales, et 13 avec cancer du côlon avec maladie oligo-métastatique.
L'essai en ouvert vise à évaluer la sécurité et les effets thérapeutiques de la combinaison du certepetide avec les régimes néoadjuvants de FOLFIRINOX. Les résultats sont attendus en 2025. L'étude fournira des données sur les tissus tumoraux pré et post-traitement pour le profilage immunitaire et des informations sur les résultats à long terme des patients.
Lisata Therapeutics (LSTA) gab die Vollständigung der Rekrutierung von Patienten in allen drei Kohorten der Phase 1b/2a CENDIFOX-Studie bekannt, die die Wirkung von certepetide in Kombination mit FOLFIRINOX-basierten Therapien bei Bauchspeicheldrüsen-, Dickdarm- und Blinddarmerkrankungen untersucht. Die von Dr. Anup Kasi am University of Kansas Cancer Center geleitete, vom Investigator initiierte Studie umfasste insgesamt 66 Patienten in drei Kohorten: 35 mit resektablem/bgrenzwertig resektablem Bauchspeicheldrüsenkrebs, 18 mit hochgradigem Dickdarm- und Blinddarmkrebs mit Peritonealmetastasen und 13 mit Dickdarmkrebs bei oligo-metastatischer Erkrankung.
Die offene Studie zielt darauf ab, die Sicherheit und therapeutischen Effekte der Kombination von certepetide mit neoadjuvanten FOLFIRINOX-Schemata zu bewerten. Ergebnisse werden für 2025 erwartet. Die Studie wird Daten zu Tumorgeweben vor und nach der Behandlung für das immunologische Profiling und Informationen über die langfristigen Ergebnisse der Patienten bereitstellen.
- Completed enrollment for all three cohorts in Phase 1b/2a trial
- Successfully recruited 66 patients across different cancer types
- Results expected in 2025
- None.
Insights
The successful completion of enrollment in the CENDIFOX trial marks a significant milestone in certepetide's clinical development program. With 66 patients enrolled across three distinct cancer cohorts, the study's scope is substantial enough to generate meaningful data. The trial's design to evaluate certepetide in combination with FOLFIRINOX-based therapies is particularly noteworthy, as it targets aggressive cancers with high unmet medical needs.
The collection of pre- and post-treatment tumor tissue data for immune profiling will provide important insights into certepetide's mechanism of action and potential efficacy. The fact that the trial includes multiple cancer types - pancreatic, colon and appendiceal - could potentially broaden certepetide's market opportunity if positive results are demonstrated. Data readout in 2025 will be a critical catalyst for Lisata's valuation.
For a small-cap biotech with a market cap of
The multi-cohort design targeting three different cancer types provides multiple shots on goal and could significantly expand the commercial potential if successful. Given the company's current market valuation, positive data from any of the cohorts in 2025 could trigger substantial share price appreciation. However, investors should note that as with any early-stage oncology trial, significant risks remain until efficacy data is available.
Phase 1b/2a open-label trial in the U.S. of certepetide in combination with neoadjuvant FOLFIRINOX-based therapies in pancreatic, colon and appendiceal cancers
BASKING RIDGE, N.J., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced the successful completion of patient enrollment in all three cohorts of the Phase 1b/2a CENDIFOX trial. This investigator-initiated trial, led by Dr. Anup Kasi at The University of Kansas (“KU”) Cancer Center, is evaluating the safety and efficacy of Lisata's iRGD cyclic peptide product candidate, certepetide, in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers.
“The successful enrollment of all three cohorts in the CENDIFOX trial is another significant milestone, bringing us closer to validating certepetide’s potential as a transformative treatment for advanced solid tumors,” stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “By addressing the unmet medical needs of patients with solid tumors, we aim to improve patient outcomes and augment the standard-of-care paradigm. We are excited about the progress of the CENDIFOX trial and eagerly anticipate reporting the results from this important study in 2025.”
The open-label CENDIFOX trial is designed to assess the safety and therapeutic effects of combining certepetide with neoadjuvant FOLFIRINOX regimens, with or without panitumumab, across pancreatic, colon, and appendiceal cancers. The study, conducted solely at the KU Cancer Center, enrolled a total of 66 patients (35 resectable and borderline resectable pancreatic cancer patients, 18 high-grade colon and appendiceal cancer patients with peritoneal metastasis, and 13 colon cancer patients with oligo-metastatic disease). The trial will provide Lisata with valuable pre- and post-treatment tumor tissue data for immune profiling, along with long-term patient outcomes information. The trial is funded by the KU Cancer Center and Lisata is supplying certepetide.
“We are delighted to complete enrollment in all three cohorts in the CENDIFOX study and are encouraged by certepetide’s potential to improve outcomes for patients with advanced solid tumors,” stated Dr. Anup Kasi, the study’s Principal Investigator at the KU Cancer Center. “We are eager to analyze the data from each cohort to determine the efficacy of this novel therapy.”
For more information on the CENDIFOX trial, please visit www.clinicaltrials.gov/study/NCT05121038.
About Certepetide
Certepetide, an internalizing RGD, or arginylglycylaspartic acid, (iRGD) cyclic peptide product, is an investigational drug designed to selectively activate the C-end rule active transport mechanism in a tissue-specific manner, resulting in systemically co-administered agents more efficiently penetrating and accumulating in the tissue. To date, certepetide has demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing oncology clinical trials designed to demonstrate its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer, as well as the combination of chemotherapy and immunotherapy in a variety of solid tumors. Beyond its promising applications in oncology, certepetide's unique mechanism of action has the potential to be explored in various non-oncology settings. Its ability to selectively target specific tissues could offer new therapeutic possibilities for a range of diseases. 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, osteosarcoma, and cholangiocarcinoma (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 internalizing RGD, or arginylglycylaspartic acid, (iRGD) 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 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 cholangiocarcinoma and other solid tumors; 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
Senior Associate
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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