Vobarilizumab
Also known as: ALX-0061, anti-IL-6R Nanobody
Summary
Vobarilizumab (ALX-0061) is a bispecific Nanobody developed by Ablynx targeting IL-6 receptor and albumin. It was investigated for rheumatoid arthritis and systemic lupus erythematosus (SLE). The albumin-binding domain extends its half-life. Clinical development was discontinued after Phase II results did not support further advancement in SLE.
Mechanism of Action
Bispecific nanobody that simultaneously targets IL-6 receptor (IL-6R) and human serum albumin (HSA); blocks IL-6 signaling by competitively inhibiting IL-6 binding to IL-6R, thereby suppressing downstream JAK/STAT3 inflammatory pathways
Routes of Administration
Goals & Uses
- Reduction of rheumatoid arthritis disease activityAnti Inflammatory / AutoimmuneModerate
- Suppression of IL-6 mediated inflammationImmunomodulationModerate
- Reduction of systemic lupus erythematosus (SLE) disease activityAnti Inflammatory / AutoimmuneLow
Contraindications
- Known hypersensitivity to vobarilizumab or Nanobody componentsImmunologicHigh
- Active serious infectionsInfectiousHigh
- Active tuberculosisInfectiousHigh
Adverse Effects
- Injection site reactionsLocalCommon
- Elevated liver enzymes (ALT/AST)HepaticUncommon
- NeutropeniaHematologicUncommonLow neutrophil count
- Infections (upper respiratory tract, urinary tract)InfectiousCommon
- HyperlipidemiaMetabolicUncommon
Drug Interactions
- Live vaccinesHigh
- CYP450 substrates with narrow therapeutic indexModerate
- Other immunosuppressants (e.g., methotrexate, azathioprine)Moderate
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patientsAgeRelative
- Patients with history of diverticulitis or GI perforationGastrointestinalRelative
- Patients with latent tuberculosisInfectious DiseaseRelative
Regulatory Status
- European UnionInvestigationalPhase II trials conducted in EU; no marketing authorization application submitted
- United StatesInvestigationalInvestigated under IND; no NDA filed; development discontinued
- United KingdomUnknownNo regulatory submission or approval known
No regulatory approvals obtained in any jurisdiction. Phase II trials conducted in RA and SLE; Ablynx was acquired by Sanofi in 2018. Development in SLE was discontinued following Phase II results.
Evidence & Sources
No sources recorded yet.