^
    6d
    REACtiVe-2: phase I evaluation of dendritic cell vaccination and agonistic CD40 therapy following (m)FOLFIRINOX in metastatic pancreatic cancer. (PubMed, Nat Commun)
    In conclusion, MesoPher/mitazalimab combination therapy is safe and tolerable in patients with metastatic PDAC and enhances systemic immune activation and local immune responses. Future research should evaluate the efficacy of this promising approach as maintenance therapy shortly after completing chemotherapy.
    P1 data • Journal
    |
    CD40 (CD40 Molecule)
    |
    5-fluorouracil • irinotecan • leucovorin calcium • MesoPher (autologous dendritic cell vaccine) • mitazalimab (ADC-1013)
    2ms
    CD40 agonist mitazalimab with mFOLFIRINOX in untreated metastatic pancreatic cancer: Biomarkers associated with outcomes from OPTIMIZE-1. (PubMed, Cell Rep Med)
    These results may inform future patient stratification strategies supporting a planned randomized confirmatory trial of mitazalimab with mFOLFIRINOX in mPDAC. This study was registered at ClinicalTrials.gov (NCT04888312).
    Journal • IO biomarker
    |
    CD40 (CD40 Molecule)
    |
    5-fluorouracil • irinotecan • leucovorin calcium • mitazalimab (ADC-1013)
    2ms
    OPTIMIZE-1: Safety and Efficacy of Mitazalimab in Combination With Chemotherapy in Pancreatic Cancer Patients (clinicaltrials.gov)
    P1/2, N=94, Active, not recruiting, Alligator Bioscience AB | Trial primary completion date: Jan 2024 --> Jun 2026
    Trial primary completion date
    |
    5-fluorouracil • irinotecan • mitazalimab (ADC-1013)
    2ms
    IGNITE: Maintenance Combinatorial Myeloid Immunotherapy for Unresectable Pancreatic Cancer (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, University of Pennsylvania
    New P2 trial
    |
    Imprime PGG (odetiglucan) • mitazalimab (ADC-1013)
    11ms
    OPTIMIZE-1: Safety and Efficacy of Mitazalimab in Combination with Chemotherapy in Pancreatic Cancer Patients (clinicaltrials.gov)
    P1/2, N=94, Active, not recruiting, Alligator Bioscience AB | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Feb 2025 --> Jan 2024
    Trial completion date • Trial primary completion date
    |
    5-fluorouracil • irinotecan • mitazalimab (ADC-1013)
    1year
    CD40 agonist mitazalimab combined with mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): updated efficacy and correlative biomarkers from the OPTIMIZE-1 trial (SITC 2024)
    These encouraging results from OPTIMIZE-1 form the basis of a future randomized confirmatory trial of mitazalimab in combination with mFOLFIRINOX in mPDAC. Ethics Approval The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines as defined by the International Conference on Harmonisation, in 14 European University Hospitals according to the study protocol and amendments, approved by local Institutional Review Boards and independent ethics committees: France:Comité de protection des personnes Est I, Centre hospitalier la Chartreuse - 1 Bld Chanoine Kir, BP 23314 21033 DIJON France Belgium: CHU UCL Namur, site Godinne, Comité d'éthique, Avenue Docteur G. Thérasse 1, 5530 YVOIR Spain: The CEIm of the Ramón y Cajal University Hospital, Madrid, Spain Patients provided written informed consent before enrolment.Download figure Open in new tab Download powerpoint Abstract 592 Figure 1 OPTIMIZE-1 dosing regimen and biomarker planView this table:View inline View popup Download powerpoint Abstract 592 Table 1 OPTIMIZE-1 outcomes
    Clinical • IO biomarker • Metastases
    |
    IFNG (Interferon, gamma) • CD40 (CD40 Molecule)
    |
    TruSight Oncology 500 Assay
    |
    5-fluorouracil • irinotecan • leucovorin calcium • mitazalimab (ADC-1013)
    over1year
    OPTIMIZE-1: Safety and Efficacy of Mitazalimab in Combination With Chemotherapy in Pancreatic Cancer Patients (clinicaltrials.gov)
    P1/2, N=94, Active, not recruiting, Alligator Bioscience AB | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    5-fluorouracil • irinotecan • mitazalimab (ADC-1013)
    over1year
    Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer (clinicaltrials.gov)
    P1, N=18, Recruiting, University of California, San Diego | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    mitazalimab (ADC-1013)
    over1year
    Combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study. (PubMed, Lancet Oncol)
    Mitazalimab with mFOLFIRINOX demonstrated manageable safety and encouraging activity, warranting continued development in a phase 3, randomised, controlled trial. The results from OPTIMIZE-1 pave the way for further exploration and confirmation of a novel immunotherapy treatment regimen for metastatic pancreatic ductal adenocarcinoma, which is a complex and aggressive cancer with very low survival rates and restricted treatment options.
    P1/2 data • Journal • Metastases
    |
    CD40 (CD40 Molecule)
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • mitazalimab (ADC-1013)
    over1year
    Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, University of California, San Diego | Initiation date: Feb 2024 --> Jun 2024
    Trial initiation date • Metastases
    |
    mitazalimab (ADC-1013)
    over1year
    OPTIMIZE-1: Safety and Efficacy of Mitazalimab in Combination With Chemotherapy in Pancreatic Cancer Patients (clinicaltrials.gov)
    P1/2, N=90, Recruiting, Alligator Bioscience AB | Active, not recruiting --> Recruiting | Phase classification: P1b/2 --> P1/2 | Trial primary completion date: Feb 2024 --> Feb 2025
    Enrollment open • Phase classification • Trial primary completion date • Combination therapy • Metastases
    |
    5-fluorouracil • irinotecan • mitazalimab (ADC-1013)
    almost2years
    Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, University of California, San Diego
    New P1 trial • Metastases
    |
    mitazalimab (ADC-1013)