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    DRUG CLASS:

    APC activator

    Related drugs:
    15d
    Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, George Washington University | Initiation date: Jan 2026 --> May 2026
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 expression
    |
    docetaxel • doxorubicin hydrochloride • albumin-bound paclitaxel • cyclophosphamide • ImmuFact (eftilagimod alpha)
    16d
    INSIGHT: Feasibility and Safety of IMP321 (Eftilagimod Alpha) for Advanced Stage Solid Tumors (clinicaltrials.gov)
    P1, N=83, Active, not recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Bavencio (avelumab) • ImmuFact (eftilagimod alpha)
    1m
    LAG-3 in (auto)immunity and cancer - Emphasising its role in antigen presenting cells. (PubMed, Autoimmun Rev)
    So far, studies show that both approaches may be safe and effective anti-cancer treatment options. This review summarises the role of LAG-3 in immune response and emphasises the role of this IC molecule and its soluble form on APCs function, while also noting the primary physiological function of LAG-3 in autoimmunity and providing a dual perspective of the pros and cons of this novel anti-cancer therapy.
    Review • Journal
    |
    LAG3 (Lymphocyte Activating 3)
    |
    ImmuFact (eftilagimod alpha)
    1m
    INSIGHT: Feasibility and Safety of IMP321 (Eftilagimod Alpha) for Advanced Stage Solid Tumors (clinicaltrials.gov)
    P1, N=110, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2025 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    Bavencio (avelumab) • ImmuFact (eftilagimod alpha)
    3ms
    A phase III placebo-controlled study of eftilagimod alfa plus pembrolizumab and chemotherapy in metastatic non-small cell lung cancer. (PubMed, Future Oncol)
    TACTI-004 will evaluate whether efti can mitigate resistance to ICIs when added to SoC in NSCLC, irrespective of PD-L1 tumor status. www.clinicaltrials.gov identifier is NCT06726265.
    P3 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • PD-L1 underexpression
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    3ms
    KEYNOTE-C34: Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC (clinicaltrials.gov)
    P2, N=171, Completed, Immutep S.A.S. | Active, not recruiting --> Completed
    Trial completion
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    7ms
    Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, George Washington University
    New P2 trial
    |
    docetaxel • doxorubicin hydrochloride • albumin-bound paclitaxel • cyclophosphamide • ImmuFact (eftilagimod alpha)
    10ms
    The inhibitory receptor Siglec-E controls antigen-presenting cell activation and T cell-mediated transplant rejection. (PubMed, Sci Transl Med)
    The human homologs Siglecs-7 and -9 were up-regulated in rejecting allograft biopsies, and their higher expression correlated with improved allograft survival. Thus, SigE/7/9 is a crucial inhibitory receptor controlling antigen-presenting cell activation and T cell-mediated transplant rejection, offering therapeutic potential.
    Review • Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha)
    11ms
    KEYNOTE-F91: Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004) (clinicaltrials.gov)
    P3, N=756, Recruiting, Immutep S.A.S. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • pemetrexed • ImmuFact (eftilagimod alpha)
    1year
    KEYNOTE-C34: Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC (clinicaltrials.gov)
    P2, N=171, Active, not recruiting, Immutep S.A.S. | Trial completion date: Mar 2025 --> Oct 2025
    Trial completion date • IO biomarker
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    1year
    Pembrolizumab in Combination with Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients with Soft Tissue Sarcoma - EFTISARC-NEO Trial (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, Maria Sklodowska-Curie National Research Institute of Oncology | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    1year
    TACTI 002: Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC (clinicaltrials.gov)
    P2, N=187, Completed, Immutep S.A.S. | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)