Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ID: DRG0EZVZS)
ADC Name
BYON-4413
Synonyms
BYON-4413; BYON4413
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Organization
Byondis (Originator)
Drug Status
Phase 1
Drug-to-Antibody Ratio
1.9
Structure
Antibody Name
Anti-CD123 IgG1 mAb
  Antibody Info 
Antigen Name
Interleukin-3 receptor subunit alpha (IL3RA)
  Antigen Info 
Payload Name
Seco-DUBA
  Payload Info 
Payload Target
Human deoxyribonucleic acid (hDNA)
  Target Info 
Linker Name
Mal-PEG2-Val-Cit-PABA-Cyclization Spacer
  Linker Info 
Conjugate Type
Reactive Cysteines
Combination Type
duocarmazine
2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
Disease Name Phase 1 Phase 2 Phase 3 Approved
Myelodysplastic syndrome
1 Trials
Clinical trial identifier
NCT06359002; EudraCT2023-507781-13; EUCT2023-507781-13-00
Acute myeloid leukaemia
1 Trials
Clinical trial identifier
NCT06359002; EudraCT2023-507781-13; EUCT2023-507781-13-00
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT06359002
PHASE1
A First-in-human Dose Escalation and Expansion Trial With the Antibody-drug Conjugate BYON4413 to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms.

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Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Eligible patients have R/R AML or high-blast MDS post-HMA failure (&ge;3 cycles) with ECOG 0-2; exclusions comprise prior CD123 therapy, recent HSCT (<100 days), unresolved toxicities (>CTCAE Gr1), APL/CNS involvement, active hepatitis, or significant cardiovascular/pulmonary/ocular comorbidities.
Administration Dosage
BYON4413 will be administered by IV infusion.
Related Clinical Trial
NCT Number NCT06359002  Clinical Status PHASE1
Clinical Description A First-in-human Dose Escalation and Expansion Trial With the Antibody-drug Conjugate BYON4413 to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms.
Primary Endpoint
The study evaluates dose-limiting toxicities during initial 21 days and assesses composite complete remission rates (CR+CRh+CRi per ELN 2022) up to 24 months in dose escalation and expansion phases.
Other Endpoint
Safety parameters include AE monitoring and dose modifications for 24 months, while pharmacokinetics (Cmax, Tmax, AUC) and immunogenicity (anti-drug antibodies) are tracked alongside efficacy measures (ORR, DoR, RFS, EFS, OS) using ELN 2022 criteria throughout the study period.
References
Ref 1 Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms.