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    DRUG:

    AFM24

    i
    Other names: AFM24, AFM-24, AFM 24
    Company:
    Affimed, Xoma
    Drug class:
    EGFR inhibitor, CD16A agonist
    Related drugs:
    1d
    NK cell-mediated tumor cell killing by bispecific innate cell engagers induces ADCC-mediated activation of primary human dendritic cells. (PubMed, Oncoimmunology)
    Nevertheless, ADCC boosted the capacity of cDC1 and DC2 to prime naïve T cell responses but not of DC3. Thus, our data suggests that the therapy with bispecific antibodies targeting NK cells may have the potential to facilitate adaptive antitumor immune responses via activation of cDC1 and DC2.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    AFM24
    5ms
    AFM24-102: Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers (clinicaltrials.gov)
    P1/2, N=112, Terminated, Affimed GmbH | Trial completion date: Nov 2025 --> Jun 2025 | Recruiting --> Terminated; The trial was prematurely discontinued due to the financial situation of the sponsor and not for safety or efficacy reasons.
    Trial completion date • Trial termination
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M • EGFR wild-type • EGFR positive
    |
    Tecentriq (atezolizumab) • AFM24
    6ms
    Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov)
    P1/2, N=85, Terminated, Affimed GmbH | Completed --> Terminated; Enrollment into expansion cohorts in Phase 2 part was terminated due to sponsor decision
    Trial termination
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS wild-type • RAS wild-type
    |
    AFM24
    12ms
    First-in-Human Phase 1 study of a CD16A bispecific innate cell engager, AFM24, targeting EGFR-expressing solid tumors. (PubMed, Clin Cancer Res)
    AFM24 was well tolerated with 480 mg established as the RP2D. AFM24 could be a novel therapy for patients with EGFR-expressing solid tumors with suitable tolerability and appropriate pharmacokinetic properties for further development in combination with other immuno-oncology therapeutics.
    P1 data • Journal
    |
    EGFR (Epidermal growth factor receptor) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    EGFR expression
    |
    AFM24
    over1year
    AFM24-102: Study to Assess AFM24 in Combination with Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers (clinicaltrials.gov)
    P1/2, N=148, Recruiting, Affimed GmbH | Trial completion date: Jun 2025 --> Nov 2025 | Trial primary completion date: Sep 2024 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M • EGFR wild-type • EGFR positive
    |
    Tecentriq (atezolizumab) • AFM24
    over1year
    Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov)
    P1/2, N=85, Completed, Affimed GmbH | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Jun 2024
    Trial completion • Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    AFM24
    almost2years
    Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing Cancers (clinicaltrials.gov)
    P1/2, N=11, Terminated, NKGen Biotech, Inc. | N=121 --> 11 | Trial completion date: Nov 2025 --> Sep 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Sep 2023; Affimed and NKGen have mutually decided to discontinue the study. Affimed will evaluate the best options to advance this project with an allogeneic off-the-shelf NK cell product while NKGen will focus on CNS with SNK01.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR expression • EGFR wild-type • EGFR positive
    |
    troculeucel (SNK01) • AFM24
    over2years
    Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov)
    P1/2, N=85, Active, not recruiting, Affimed GmbH | Recruiting --> Active, not recruiting | N=155 --> 85 | Trial primary completion date: Apr 2024 --> Jul 2023
    Enrollment closed • Enrollment change • Trial primary completion date • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS wild-type • RAS wild-type
    |
    AFM24
    over2years
    Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers (clinicaltrials.gov)
    P1/2, N=148, Recruiting, Affimed GmbH | N=105 --> 148
    Enrollment change • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M • EGFR wild-type • EGFR positive
    |
    Tecentriq (atezolizumab) • AFM24
    over2years
    Investigating the novel CD16A and epidermal growth factor receptor (EGFR) bispecific innate cell engager, AFM24, to leverage the innate immune system: Interim results from the colorectal cancer (CRC) cohort. (ASCO 2023)
    The novel mechanism of action of AFM24 may provide an alternative treatment approach for patients with EGFR+ solid tumors. In this study, AFM24 monotherapy was adequately tolerated in a heavily pretreated population of patients with EGFR+ CRC. AFM24 is also being investigated in combination with atezolizumab and autologous NK cells in various EGFR+ solid tumors.
    PD(L)-1 Biomarker
    |
    EGFR (Epidermal growth factor receptor) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    EGFR mutation • EGFR expression • EGFR wild-type • RAS wild-type
    |
    Tecentriq (atezolizumab) • AFM24
    over2years
    Leveraging innate immunity with AFM24, a novel CD16A and epidermal growth factor receptor (EGFR) bispecific innate cell engager: Interim results for the non-small cell lung cancer (NSCLC) cohort. (ASCO 2023)
    AFM24 demonstrated clinical activity and acceptable safety in heavily pretreated patients with EGFR mutant NSCLC. The novel mechanism of action of AFM24 could add to the therapeutic options for patients with EGFR expressing tumors and is under clinical evaluation as a single agent and in combination with atezolizumab or autologous NK cells. Clinical trial information: NCT04259450.
    PD(L)-1 Biomarker
    |
    EGFR (Epidermal growth factor receptor) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    EGFR mutation • EGFR positive
    |
    Tecentriq (atezolizumab) • AFM24
    over3years
    AFM24 and atezolizumab combination in patients with advanced epidermal growth factor receptor-expressing (EGFR+) solid tumors: Initial results from the Phase 1 dose-escalation study (SITC 2022)
    Clinical activity was observed in two patients. Dose escalation is proceeding at 480 mg and enrollment has begun.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    EGFR expression
    |
    Tecentriq (atezolizumab) • AFM24