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    DRUG:

    certepetide (LSTA1)

    i
    Other names: LSTA1, CEND-1, Irgd, CEND1, QLC12102, Internalised-arginylglycylaspartic acid cyclic peptide
    Company:
    Lisata Therap, Qilu Pharma
    Drug class:
    Capillary permeability modulator, NRP1 modulator
    Related drugs:
    2ms
    FORTIFIDE: LSTA1 Phase 1b/2a Continuous Infusion Trial in MPDAC (clinicaltrials.gov)
    P1/2, N=30, Not yet recruiting, Lisata Therapeutics, Inc.
    New P1/2 trial • Metastases
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • certepetide (LSTA1)
    2ms
    CEND-1 Injection (QLC12102) in Patients With Advanced Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=50, Completed, Qilu Pharmaceutical Co., Ltd. | Recruiting --> Completed | Phase classification: P1b/2 --> P1/2 | Trial completion date: May 2023 --> Jun 2024 | Trial primary completion date: May 2023 --> Jun 2024
    Trial completion • Phase classification • Trial completion date • Trial primary completion date • Metastases
    |
    paclitaxel • certepetide (LSTA1)
    2ms
    CEND1-202: A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P2, N=120, Recruiting, Qilu Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • certepetide (LSTA1)
    3ms
    Intraperitoneal LSTA1 in CRS-HIPEC (clinicaltrials.gov)
    P1, N=0, Withdrawn, University of California, San Diego | N=21 --> 0 | Trial completion date: Dec 2029 --> Jun 2024 | Recruiting --> Withdrawn | Trial primary completion date: Dec 2028 --> Jun 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Surgery
    |
    certepetide (LSTA1)
    4ms
    Haystack Oncology and Lisata Therapeutics Initiate Research Collaboration to Use the Haystack MRD Technology to Evaluate Efficacy of Pancreatic Cancer Therapy (GlobeNewswire)
    "Haystack Oncology...and Lisata Therapeutics...announced a research collaboration. Lisata will deploy the highly sensitive Haystack MRD technology for the detection of circulating tumor DNA (ctDNA) in a clinical study evaluating certepetide plus chemotherapy as an investigational treatment for metastatic pancreatic cancer. In the FORTIFIDE study, Lisata is investigating the safety, tolerability, and efficacy of its lead product candidate, certepetide...in subjects with metastatic pancreatic ductal adenocarcinoma (mPDAC) who have progressed on FOLFIRINOX, a treatment for pancreatic cancer. As part of this research, Lisata has engaged Haystack to use its MRD technology to measure serum ctDNA levels at multiple timepoints in patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of certepetide."
    Licensing / partnership
    |
    certepetide (LSTA1)
    9ms
    A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
    New P2 trial • Combination therapy • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • certepetide (LSTA1)
    10ms
    A Randomised, double-blinded phase II study of gemcitabine and nab-paclitaxel with CEND-1 or placebo in patients with untreated metastatic pancreatic ductal adenocarcinoma (ACTRN12621001290886)
    P2, N=155, Active, not recruiting, Australasian Gastro-Intestinal Cancer Trials Group | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • certepetide (LSTA1)
    11ms
    BOLSTER: A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=80, Recruiting, Lisata Therapeutics, Inc. | N=120 --> 80
    Enrollment change • Metastases
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • paclitaxel • certepetide (LSTA1)
    12ms
    BOLSTER: A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=120, Recruiting, Lisata Therapeutics, Inc.
    Trial completion date • Trial primary completion date • Metastases
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • paclitaxel • docetaxel • certepetide (LSTA1)
    12ms
    BOLSTER: A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=120, Recruiting, Lisata Therapeutics, Inc. | Phase classification: P2a --> P2
    Phase classification • Metastases
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • paclitaxel • docetaxel • certepetide (LSTA1)
    over1year
    BOLSTER: A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P2a, N=120, Recruiting, Lisata Therapeutics, Inc. | Trial completion date: May 2026 --> Dec 2025 | Trial primary completion date: May 2026 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • paclitaxel • docetaxel • certepetide (LSTA1)
    over1year
    A phase Ib/II, open-label, multicenter study to evaluate the safety, efficacy, and pharmacokinetics/pharmacodynamics of αvβ3/5 integrin and neuropilin-1 targeting peptide LSTA1 in patients with metastatic pancreatic ductal adenocarcinoma. (ASCO 2023)
    Here we report the safety and efficacy results from a Phase Ib/II, multicenter study of LSTA1 plus (SoC) gemcitabine and locally produced nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). LSTA1 combined with SoC showed an acceptable safety profile in patients with mPDAC. Compared with historical SoC data, LSTA1 plus SoC numerically improved ORR and PFS. Higher NRP1 expression is associated with better ORR and PFS, suggesting NRP1 may be a potential biomarker of LSTA1 plus chemotherapy for mPDAC treatment.
    Clinical • P1/2 data • PK/PD data • Metastases
    |
    NRP1 (Neuropilin 1)
    |
    gemcitabine • albumin-bound paclitaxel • certepetide (LSTA1)
    over2years
    Preclinical assessment of the pharmacokinetics, disposition, and duration of action of the dual alphav-integrin and neuropilin-1 targeting peptide CEND-1 (ESMO 2022)
    The duration of the tumor-penetrating effect of CEND-1 was evaluated by assessing tumor accumulation of Evans Blue and Doxorubicin in two different models of hepatocellular carcinoma (HCC): TGFα/c-myc-double transgenic mice and HepG2 xenografted mice. Conclusions These results indicate a favourable in vivo PK profile of CEND-1 after intravenous administration and demonstrate a specific and long-lasting tumour homing and tumor penetrability. Therefore, even single injections of CEND-1 may elicit long-lasting tumor PK improvements for co-administered anti-cancer agents.
    PK/PD data • Preclinical
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • NRP1 (Neuropilin 1) • TGFA (Transforming Growth Factor Alpha)
    |
    doxorubicin hydrochloride • certepetide (LSTA1)
    over2years
    iRGD mediated delivery of neoantigens to enable immunotherapy in integrin b5-rich tumors (AACR 2022)
    Our recent data shows that KrasLSL-G12D/+ Trp53LSL-R172H/+ Pdx1-Cre (KPC) mice treated with iRGD co-administered with Gemcitabine increased survival compared to drug alone. Our preliminary data showed tumor regression in 70%, and complete response in 42% of the mice treated with iRGD plus OVA1. We are now working on adapting this strategy to pancreatic cancer.
    Tumor Mutational Burden • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • NRP1 (Neuropilin 1) • PDX1 (Pancreatic And Duodenal Homeobox 1)
    |
    KRAS G12D • TMB-L • KRAS G12
    |
    gemcitabine • certepetide (LSTA1)
    almost3years
    CENDIFOX: CEND-1 in Combination With Neoadjuvant FOLFIRINOX With or Without Panitumumab (clinicaltrials.gov)
    P1b/2a, N=50, Recruiting, Anup Kasi | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    BRAF (B-raf proto-oncogene)
    |
    5-fluorouracil • Vectibix (panitumumab) • oxaliplatin • irinotecan • leucovorin calcium • certepetide (LSTA1)
    over3years
    iRGD-liposomes enhance tumor delivery and therapeutic efficacy of antisense oligonucleotide drugs against primary prostate cancer and bone metastasis. (PubMed, Adv Funct Mater)
    Overall, we provide here a delivery system that can significantly increase ASO accumulation and efficacy in solid tumors. These benefits are achieved without significant side effects, providing a way to increase the antitumor efficacy of ASOs.
    Clinical • Journal
    |
    AR (Androgen receptor)
    |
    AR expression
    |
    certepetide (LSTA1)
    4years
    CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P1, N=30, Completed, DrugCendR Inc. | Active, not recruiting --> Completed | Trial completion date: Dec 2020 --> Jun 2020 | Trial primary completion date: Nov 2019 --> Jun 2020
    Clinical • Trial completion • Trial completion date • Trial primary completion date • Combination therapy
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    gemcitabine • albumin-bound paclitaxel • certepetide (LSTA1)