BI-836858

Monoclonal Antibody (fully Human Anti CD33 Antibody)Rx: ResearchCompound: Investigational

Also known as: anti-CD33 mAb BI-836858, BI 836858

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

BI-836858 is a fully human, Fc-optimized anti-CD33 monoclonal antibody developed by Boehringer Ingelheim for treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). It binds CD33 on leukemic blasts and utilizes enhanced ADCC/ADCP activity due to its engineered Fc region. Clinical trials have investigated it as monotherapy and in combination regimens in relapsed/refractory AML and MDS.

Mechanism of Action

Fully human IgG1 monoclonal antibody targeting CD33 (Siglec-3) expressed on myeloid leukemia cells. Mediates antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) against CD33-positive malignant cells, leveraging enhanced Fc-mediated effector functions.

Routes of Administration

Intravenous

Goals & Uses

  • Combination therapy in AMLOncologyLow
  • Treatment of relapsed/refractory acute myeloid leukemia (AML)OncologyLow
  • Treatment of myelodysplastic syndromes (MDS)OncologyLow

Contraindications

  • Hypersensitivity to BI-836858 or excipientsAllergy/ImmunologyHigh
  • Severe uncontrolled infectionInfectionHigh

Adverse Effects

  • ThrombocytopeniaHematologicCommonLow platelet count
  • Febrile neutropeniaHematologic/InfectiousUncommon
  • NeutropeniaHematologicCommonLow neutrophil count
  • FatigueGeneralCommonLow energy or tiredness
  • Infusion-related reactionsHypersensitivityCommon

Drug Interactions

  • Live vaccinesHigh
  • CytarabineModerate

Population Constraints

  • Pediatric patientsAgeRelative
  • Pregnant or breastfeeding womenReproductiveRelative
  • Severe hepatic impairmentOrgan ImpairmentRelative

Regulatory Status

  • European UnionInvestigationalEvaluated in European clinical trial sites; no EMA approval granted.
  • United StatesInvestigationalInvestigated under IND; no FDA approval granted as of knowledge cutoff.

BI-836858 has not received regulatory approval in any jurisdiction as of the knowledge cutoff. It has been evaluated in Phase I/II clinical trials (e.g., NCT02240706 in AML/MDS). Development status beyond early-phase trials is uncertain.

Evidence & Sources

No sources recorded yet.

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