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    6ms
    First-in-Human Dose Escalation Study of AFM28 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=50, Recruiting, Affimed GmbH
    Trial completion date • Trial primary completion date
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    IL3RA (Interleukin 3 Receptor Subunit Alpha)
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    CD123 positive • IL3RA positive
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    AFM28
    8ms
    Novel bispecific innate cell engager AFM28 efficiently directs allogenic NK cells to CD123+ leukemic blasts and stem cells in Acute Myeloid Leukemia and Myelodysplastic Neoplasms (DGHO 2023)
    AFM28 induced NK cell activation at low picomolar concentrations and mediated efficacious and significant depletion of CD123+ blasts and LSCs in primary AML and HR-MDS samples. The ability to eradicate LSCs without seriously affecting normal hematopoiesis promises durable responses and the potential for long-term remission. A phase 1 dose-escalation study of AFM28 monotherapy (NCT05817058) has been initiated and the combination with allogenic NK cells is envisioned.
    IO biomarker
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    KIT (KIT proto-oncogene, receptor tyrosine kinase) • CD123 (Interleukin 3 Receptor Subunit Alpha) • CD34 (CD34 molecule) • FCGR3A (Fc Fragment Of IgG Receptor IIIa) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
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    CD123 expression • IL3RA expression
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    AFM28
    1year
    ENGAGING INNATE IMMUNITY: A PHASE 1 DOSE ESCALATION STUDY TO ASSESS SAFETY AND TOLERABILITY OF AFM28 MONOTHERAPY IN PATIENTS WITH RELAPSED/REFRACTORY CD123-POSITIVE ACUTE MYELOID LEUKEMIA (AML) (EHA 2023)
    N/A ADCC, Acute myeloid leukemia, NK cell, Immune therapy
    Clinical • P1 data
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    FLT3 (Fms-related tyrosine kinase 3) • CD123 (Interleukin 3 Receptor Subunit Alpha) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
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    CD123 positive • CD123 expression
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    AFM28
    over1year
    PRE‑CLINICAL MODELS OF ACUTE MYELOID LEUKEMIA DEMONSTRATE AFM28 EFFICIENTLY DIRECTS ALLOGENEIC NK CELLS TO CD123+ LEUKEMIC BLASTS AND STEM CELLS (EBMT 2023)
    AFM28 induced highly potent and selective lysis of CD123+ leukemic cells, including LSCs and progenitor cells, by allogeneic NK cells. The capacity to eradicate LSCs could increase the frequency and durability of responses, induce long-term remission, and prevent disease relapse after conventional treatment or aSCT in patients with AML. A first-in-human clinical investigation of AFM28 is being initiated.
    Preclinical
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    CD123 (Interleukin 3 Receptor Subunit Alpha) • CD34 (CD34 molecule) • CSF2 (Colony stimulating factor 2) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
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    CD123 expression
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    AFM28
    over2years
    AFM28, a Novel Bispecific Innate Cell Engager (ICE®), Designed to Selectively Re-Direct NK Cell Lysis to CD123+ Leukemic Cells in Acute Myeloid Leukemia and Myelodysplastic Syndrome (ASH 2021)
    AFM28 is currently being prepared for first-in-human clinical investigation. High affinity binding, potent induction of NK cell activation, and extended cell surface retention suggest AFM28 endows NK cells with CAR-like properties and may hold particular promise when combined with allogeneic NK cell therapy, for example within a pre-complexed NK cell product.
    IO biomarker
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    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD123 (Interleukin 3 Receptor Subunit Alpha) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
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    AFM28