vixtimotamab (AMV564) / Affimed 
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 0 Diseases   3 Trials   3 Trials   108 News 
  • ||||||||||  vixtimotamab (AMV564) / Affimed
    Preclinical, Journal:  Control of acute myeloid leukemia and generation of immune memory in vivo using AMV564, a bivalent bispecific CD33 x CD3 T cell engager. (Pubmed Central) -  May 2, 2024   
    In addition to the anti-tumor effects of AMV564 on the clearance of MOLM13CG cells in vivo, similar effects were seen when primary CD33+ human AML cells were engrafted in NSG mice even when the human T cells made up only 2% of the peripheral blood cells and AML cells made up 98%. These studies suggest that AMV564 is a novel and effective bispecific diabody for the targeting of CD33+ AML that may provide long-term survival advantages in the clinic.
  • ||||||||||  vixtimotamab (AMV564) / Affimed
    Preclinical, Journal, Myeloid-derived suppressor cells:  Immunodepletion of MDSC by AMV564, a Novel Bivalent Bispecific CD33/CD3 T-Cell Engager ex vivo in MDS and melanoma. (Pubmed Central) -  Jun 8, 2022   
    P1
    AMV564 was active in vivo in a leukemia xenograft model when co-administered with healthy donor PBMC. Our findings provide a strong rationale for clinical investigation of AMV564 as both a single agent or in combination with anti-PD1 antibody, and in particular, for the treatment of cancers resistant to checkpoint inhibitors.
  • ||||||||||  Review, Journal:  CD33-Targeted Therapies: Beating the Disease or Beaten to Death? (Pubmed Central) -  Dec 16, 2021   
    Gemtuzumab ozogamicin was the first and only CD33-directed antibody-drug conjugate to be US Food and Drug Administration approved for AML...Promising new strategies include cellular therapy mechanisms and linker molecules. This is an exciting target that requires a considerable amount of precision to yield clinical benefit.
  • ||||||||||  vixtimotamab (AMV564) / Affimed
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases:  Study of AMV564 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) -  Oct 19, 2021   
    P1,  N=65, Active, not recruiting, 
    doi: https://doi.org/10.1182/blood-2019-131041 Recruiting --> Active, not recruiting | N=116 --> 65 | Trial completion date: Sep 2022 --> Dec 2021 | Trial primary completion date: Sep 2021 --> Dec 2021
  • ||||||||||  vixtimotamab (AMV564) / Affimed
    Trial completion, Trial completion date:  Study of AMV564 in Patients With AML (clinicaltrials.gov) -  Oct 12, 2021   
    P1,  N=53, Completed, 
    Recruiting --> Active, not recruiting | N=116 --> 65 | Trial completion date: Sep 2022 --> Dec 2021 | Trial primary completion date: Sep 2021 --> Dec 2021 Active, not recruiting --> Completed | Trial completion date: Dec 2021 --> Nov 2020
  • ||||||||||  AMV-564 / Affimed
    Repolarization of T cells by AMV564 in patients progressing on checkpoint blockade (Poster Hall) -  Oct 1, 2021 - Abstract #SITC2021SITC_622;    
    P1
    Extremely elevated levels of regulatory T cells were often observed: after treatment with AMV564, a Th-1-like repolarization of these cells was apparent, often associated with reduction in CD25 (figure 3). Conclusions Treatment with AMV564 yielded substantial reductions in MDSC and favorable polarization of CD8 and CD4 T cells, including Th1-like polarization of Treg. This signature was apparent in patients previously treated with checkpoint inhibitors, despite strong induction of MDSC in response to T cell activation, and high baseline levels (>20%) of Treg. Trial Registration NCT04128423
  • ||||||||||  AMV-564 / Affimed
    ReSTORE T cell engager platform depletes MDSC in parallel with antigen-specific solid tumor cytotoxicity (Poster Hall) -  Oct 1, 2021 - Abstract #SITC2021SITC_604;    
    P1
    The core function of this platform utilizes AMV564, a clinically active molecule that has been shown in a phase 1 study to selectively deplete myeloid-derived suppressor cells (MDSC) and produce clinical responses in cancer patients (NCT04128423).1 Increased levels of MDSC in cancer patients correlate with reduced overall survival, as MDSC suppressive factors impair T cell activation and anti-tumor immunity...Conclusions The clinically validated MDSC-depleting core of the ReSTORE platform molecules allow targeting of specific antigens associated with a variety of solid and hematologic tumor indications. This antigen-specific cytotoxicity of cancer cells occurs in parallel with control of the immunosuppressive MDSC.
  • ||||||||||  AMV-564 / Affimed, Keytruda (pembrolizumab) / Merck (MSD)
    [VIRTUAL] MDSC suppress the T cell repertoire and contribute to a pathologic cytokine milieu in cancer patients () -  Mar 13, 2021 - Abstract #AACR2021AACR_4668;    
    Repertoire expansion correlated with increases in effector memory CD8 T cells. These findings in patients treated with AMV564 support the role of MDSC in both limiting the priming and activation of anti-tumor T cells as well as contributing to an immune suppressive and pathologic cytokine response to T cell activation.
  • ||||||||||  AMV-564 / J&J, Affimed
    [VIRTUAL] Selectivity of T Cell Engager AMV564 Against Different Leukemic Blast Populations and Potential Application for Patient Selection (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_2439;    
    Furthermore, significant differences in potency across AML blasts were observed, which could be further impacted by the available T cells. While AMV564 has demonstrated anti-leukemic activity across an unselected relapsed/refractory AML population, this novel assay could be used to select patients in whom blasts are expressing CD33 in a predominantly clustered configuration, and thus identify patients most likely to experience deeper and more durable responses with AMV564 monotherapy.
  • ||||||||||  vixtimotamab (AMV564) / Affimed
    Enrollment closed, Enrollment change:  Study of AMV564 in Patients With AML (clinicaltrials.gov) -  May 26, 2020   
    P1,  N=53, Active, not recruiting, 
    Single-agent anti-tumor activity was observed in an ovarian cancer patient. N=148 --> 53 | Recruiting --> Active, not recruiting
  • ||||||||||  vixtimotamab (AMV564) / Affimed
    Enrollment closed, Trial primary completion date:  A Phase 1 Study of AMV564 in Patients With Intermediate or High-Risk Myelodysplastic Syndromes (clinicaltrials.gov) -  Oct 17, 2019   
    P1,  N=80, Active, not recruiting, 
    AMV564 is well-tolerated and demonstrates anti-leukemic activity through T-cell engagement. Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2019 --> Mar 2020
  • ||||||||||  vixtimotamab (AMV564) / Affimed
    Trial completion date, Trial primary completion date:  Study of AMV564 in Patients With AML (clinicaltrials.gov) -  Oct 8, 2019   
    P1,  N=148, Recruiting, 
    Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2019 --> Mar 2020 Trial completion date: Jun 2020 --> Dec 2021 | Trial primary completion date: Jun 2020 --> Dec 2021
  • ||||||||||  AMV-564 / J&J, Affimed
    AMV564, a novel bivalent, bispecific T-cell engager, targets myeloid-derived suppressor cells (Potomac Ballroom CD) -  Oct 2, 2019 - Abstract #SITC2019SITC_356;    
    Treatment with AMV564 selectively depletes MDSCs in a dose-dependent fashion both ex vivo and in patients. The ability of AMV564 to deplete MDSCs while activating T cells should lower the threshold necessary for a patient to respond to immunotherapy, and these results indicate potential for benefit in solid tumor indications where elevated MDSCs are associated with poor outcomes including inadequate response to immunotherapy.
  • ||||||||||  AMV-564 / J&J, Affimed, flotetuzumab (MGD006) / Servier, MacroGenics, JNJ-63709178 / J&J, Genmab
    Review, Journal:  Bispecific Antibodies for the Treatment of Acute Myeloid Leukemia. (Pubmed Central) -  Jun 15, 2019   
    Bispecific antibodies represent a promising immunotherapeutic approach for the treatment of cancer. The results of ongoing studies in AML will elucidate the potential for these agents in AML.
  • ||||||||||  vixtimotamab (AMV564) / Affimed
    Enrollment change, Trial completion date, Trial primary completion date:  A Phase 1 Study of AMV564 in Patients With Intermediate or High-Risk Myelodysplastic Syndromes (clinicaltrials.gov) -  Jan 23, 2019   
    P1,  N=80, Recruiting, 
    The results of ongoing studies in AML will elucidate the potential for these agents in AML. N=56 --> 80 | Trial completion date: Jul 2019 --> May 2020 | Trial primary completion date: Mar 2019 --> Aug 2019
  • ||||||||||  vixtimotamab (AMV564) / Affimed
    Enrollment change, Trial completion date, Trial primary completion date:  Study of AMV564 in Patients With AML (clinicaltrials.gov) -  Jan 22, 2019   
    P1,  N=148, Recruiting, 
    N=56 --> 80 | Trial completion date: Jul 2019 --> May 2020 | Trial primary completion date: Mar 2019 --> Aug 2019 N=50 --> 148 | Trial completion date: Feb 2020 --> Jun 2020 | Trial primary completion date: Feb 2020 --> Jun 2020
  • ||||||||||  vixtimotamab (AMV564) / Affimed
    New P1 trial:  Study of AMV564 in Patients With AML (clinicaltrials.gov) -  May 8, 2017   
    P1,  N=50, Recruiting,