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    DRUG:

    IKS03

    i
    Other names: IKS03, LCB73, NI-2201, CD19-pPBD
    Company:
    Iksuda Therap, LigaChem Biosci, Light Chain Biosci
    Drug class:
    DNA replication inhibitor, CD19-targeted antibody-drug conjugate
    Related drugs:
    1year
    A Phase 1 Cohort Dose Escalation and Expansion Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS03 in Patients with Advanced B-Cell Non-Hodgkin Lymphomas (NHL) (ASH 2023)
    IKS03 demonstrated greater activity than the clinical benchmark ADC loncastuximab tesirine. Secondary objectives include further evaluation of safety, tolerability, immunogenicity and PK profile of IKS03 as well as confirmation of the RP2D. Clinical trial information: NCT05365659.
    Clinical • P1 data • Metastases
    |
    CD19 (CD19 Molecule)
    |
    CD19 positive • CD19 expression
    |
    Zynlonta (loncastuximab tesirine-lpyl) • IKS03
    1year
    IKS03, a Novel CD19-Targeted Antibody Drug Conjugate, Induces Target Dependent In Vivo Cell Killing of B-Cell Lymphoma Xenografts By DNA Crosslinking (ASH 2023)
    IKS03 demonstrated greater in vivo efficacy than the clinical benchmark ADCs polatuzumab vedotin and loncastuximab tesirine approved for the treatment of patients with B-cell non-Hodgkin lymphomas. This is consistent with the proposed mechanism of action of CD19-mediated delivery of a PBD payload specifically to B-cell tumors. Clinical investigation in patients with advanced B-Cell Non-Hodgkin Lymphomas is being initiated (NCT05365659).
    Preclinical
    |
    CD19 (CD19 Molecule)
    |
    CD19 positive • CD19 expression
    |
    Zynlonta (loncastuximab tesirine-lpyl) • Polivy (polatuzumab vedotin-piiq) • IKS03
    2years
    IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas (clinicaltrials.gov)
    P1, N=140, Not yet recruiting, Iksuda Therapeutics Ltd. | Trial completion date: Jul 2026 --> Jul 2027 | Initiation date: Jul 2022 --> Jun 2023 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    CD19 (CD19 Molecule)
    |
    CD19 positive
    |
    IKS03
    2years
    IKS03, a Next Generation CD19-Targeted Antibody Drug Conjugate, Shows Potent Activity in Preclinical Models of Aggressive B-Cell Lymphomas (ASH 2022)
    Post tumor collection, this patient was refractory to R-CHOP therapy with disease progression within 2 months. In conclusion, IKS03 is highly effective in preclinical MCL and DLBCL xenograft models that contain some of the genetic alterations commonly found in relapsed/refractory NHL patients in need of treatment. Preclinical data further demonstrates that IKS03's advanced ADC design results in specific target-dependent in vitro activity, excellent plasma stability and allows for effective targeting of B-cell tumors while sparing normal CD19-negative cells.
    Preclinical • IO biomarker
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • CD19 (CD19 Molecule) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
    |
    MYC amplification • CD19 positive • CD19 expression
    |
    Rituxan (rituximab) • IKS03
    over2years
    IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas (clinicaltrials.gov)
    P1, N=140, Not yet recruiting, Iksuda Therapeutics Ltd.
    New P1 trial
    |
    CD19 (CD19 Molecule)
    |
    CD19 positive
    |
    IKS03