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Flysyn (4G8-SDIEM)
i
Other names: 4G8-SDIEM
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News alerts, weekly reports and conference planners
Company:
Veraxa Biotech
Drug class:
FLT3 inhibitor
Related drugs:
9ms
Phase I study evaluating the Fc-optimized FLT3 antibody FLYSYN in AML patients with measurable residual disease. (PubMed, J Hematol Oncol)
FLYSYN monotherapy is safe and well-tolerated in AML patients with MRD. Early efficacy data are promising and warrant further evaluation in an up-coming phase II trial. Trial registration This clinical is registered on clinicaltrials.gov (NCT02789254).
P1 data • Journal
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FLT3 (Fms-related tyrosine kinase 3)
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Flysyn (4G8-SDIEM)
over2years
FLYSYN-101: FLYSYN in MRD Positive AML (clinicaltrials.gov)
P1/2, N=31, Completed, Synimmune GmbH | Active, not recruiting --> Completed
Clinical • Trial completion • Minimal residual disease
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FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1) • CD69 (CD69 Molecule)
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FLT3-ITD mutation • FLT3 expression
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Flysyn (4G8-SDIEM)
over3years
[VIRTUAL] First-in-Human Phase I Dose Escalation and Expansion Study Evaluating the Fc Optimized FLT3 Antibody Flysyn in Acute Myeloid Leukemia Patients with Minimal Residual Disease (ASH 2020)
Together, the results of our phase I trial demonstrate that FLYSYN is safe and very well tolerated as monotherapy in AML patients with molecular MRD. Early efficacy data are promising and warrant further evaluation in an up-coming phase II clinical trial.
Clinical • P1 data • IO biomarker
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FLT3 (Fms-related tyrosine kinase 3) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1) • RUNX1 (RUNX Family Transcription Factor 1) • RUNX1T1 (RUNX1 Partner Transcriptional Co-Repressor 1)
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IDH2 mutation • NPM1 mutation
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Flysyn (4G8-SDIEM)
over3years
[VIRTUAL] FLYSYN: Results of the first application study of the Fc-optimized FLT3 antibody FLYSYN for the treatment of acute myeloid leukemia with minimal residual disease (DGHO 2020)
The results of our phase I trial demonstrate that FLYSYN is safe and very well tolerated as monotherapy in AML patients with molecular MRD. Early efficacy data are promising and warrant further evaluation in an up-coming phase II clinical trial.
IO biomarker
|
FLT3 (Fms-related tyrosine kinase 3) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1) • RUNX1 (RUNX Family Transcription Factor 1)
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IDH2 mutation • NPM1 mutation
|
Flysyn (4G8-SDIEM)
over3years
[VIRTUAL] FLYSYN: Results of the first application study of the Fc-optimized FLT3 antibody FLYSYN for the treatment of acute myeloid leukemia with minimal residual disease (DGHO 2020)
The results of our phase I trial demonstrate that FLYSYN is safe and very well tolerated as monotherapy in AML patients with molecular MRD. Early efficacy data are promising and warrant further evaluation in an up-coming phase II clinical trial.
IO biomarker
|
FLT3 (Fms-related tyrosine kinase 3) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1) • RUNX1 (RUNX Family Transcription Factor 1)
|
IDH2 mutation • NPM1 mutation
|
Flysyn (4G8-SDIEM)
over3years
[VIRTUAL] FLYSYN: Results of the first application study of the Fc-optimized FLT3 antibody FLYSYN for the treatment of acute myeloid leukemia with minimal residual disease (DGHO 2020)
The results of our phase I trial demonstrate that FLYSYN is safe and very well tolerated as monotherapy in AML patients with molecular MRD. Early efficacy data are promising and warrant further evaluation in an up-coming phase II clinical trial.
IO biomarker
|
FLT3 (Fms-related tyrosine kinase 3) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1) • RUNX1 (RUNX Family Transcription Factor 1)
|
IDH2 mutation • NPM1 mutation
|
Flysyn (4G8-SDIEM)
over3years
[VIRTUAL] FLYSYN: Results of the first application study of the Fc-optimized FLT3 antibody FLYSYN for the treatment of acute myeloid leukemia with minimal residual disease (DGHO 2020)
The results of our phase I trial demonstrate that FLYSYN is safe and very well tolerated as monotherapy in AML patients with molecular MRD. Early efficacy data are promising and warrant further evaluation in an up-coming phase II clinical trial.
IO biomarker
|
FLT3 (Fms-related tyrosine kinase 3) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1) • RUNX1 (RUNX Family Transcription Factor 1)
|
IDH2 mutation • NPM1 mutation
|
Flysyn (4G8-SDIEM)
4years
FLYSYN-101: FLYSYN in MRD Positive AML (clinicaltrials.gov)
P1/2, N=31, Active, not recruiting, Synimmune GmbH | Recruiting --> Active, not recruiting
Clinical • Enrollment closed • Minimal residual disease
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FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1)
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FLT3-ITD mutation • FLT3 expression
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Flysyn (4G8-SDIEM)
over4years
Induction of NK Cell Reactivity against B-Cell Acute Lymphoblastic Leukemia by an Fc-Optimized FLT3 Antibody. (PubMed, Cancers (Basel))
At present, we evaluate an Fc-optimized (amino acid substitutions S239D/I332E) FLT3 antibody termed 4G8-SDIEM (FLYSYN) in patients with acute myeloid leukemia (NCT02789254)...FLT3 expression did not correlate with that of CD20, which is targeted by Rituximab, a therapeutic monoclonal antibody (mAb) employed in B-ALL treatment regimens...This was mirrored by potent 4G8-SDIE mediated NK cell ADCC in experiments with FLT3-transfectants, the cell line SEM and primary cells as target cells. Taken together, the findings presented in this study provide evidence that 4G8-SDIE may be a promising agent for the treatment of B-ALL, particularly in CD20-negative cases.
Journal
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FLT3 (Fms-related tyrosine kinase 3)
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Rituxan (rituximab) • Flysyn (4G8-SDIEM)
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