Bizaxofusp
Also known as: EGF-PE38, IL-4(38-37)-PE38KDEL, MDNA55
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Summary
Bizaxofusp (formerly MDNA55) is an investigational EGF-targeted immunotoxin designed for convection-enhanced delivery (CED) directly into brain tumors, particularly glioblastoma multiforme (GBM). It selectively targets EGFR-overexpressing tumor cells and delivers a potent cytotoxic payload. It is in late-stage clinical development for recurrent GBM.
Mechanism of Action
Bizaxofusp is a recombinant fusion protein consisting of human epidermal growth factor (EGF) fused to a truncated form of Pseudomonas exotoxin A (PE38). It binds to EGF receptor (EGFR/ErbB1) overexpressed on tumor cells, is internalized, and the exotoxin moiety inhibits protein synthesis via ADP-ribosylation of elongation factor 2 (EF-2), leading to tumor cell apoptosis.
Routes of Administration
Goals & Uses
- Targeting EGFR-overexpressing solid tumorsOncologyLow
- Treatment of recurrent glioblastoma multiforme (GBM)OncologyModerate
- Tumor debulking prior to additional therapyOncology Combination StrategyLow
Contraindications
- Hypersensitivity to Pseudomonas exotoxin componentsImmunologicHigh
- Coagulopathy or bleeding diathesisHematologicModerate
- Active systemic infectionInfectiousHigh
- Poor performance status precluding neurosurgeryClinicalModerate
Adverse Effects
- HeadacheNeurologicCommonPain in the head or upper neck
- SeizuresNeurologicalUncommon
- FatigueGeneralCommonLow energy or tiredness
- Intracranial hemorrhageNeurologicalRare
- Cerebral edemaNeurologicalCommon
- Neurological deficits (focal)NeurologicalCommon
Drug Interactions
- Immunosuppressive agentsLow
- Corticosteroids (e.g., dexamethasone)Low
Population Constraints
- EGFR-negative tumor patientsBiomarker / Tumor BiologyRelative
- Pediatric patientsAgeRelative
- Pregnant or breastfeeding womenReproductiveRelative
- Patients with prior severe neurological compromiseClinicalRelative
Regulatory Status
- European UnionInvestigationalNot approved in the European Union; investigational use only.
- United StatesInvestigationalFDA Breakthrough Therapy Designation granted for recurrent glioblastoma. Not approved; Phase 2/3 clinical trials conducted.
- United KingdomInvestigationalNot approved by MHRA; investigational status only.
Bizaxofusp received FDA Breakthrough Therapy Designation for recurrent glioblastoma. It is not currently approved in any jurisdiction. Phase 2/3 trials have been conducted. Previously developed by Medicenna Therapeutics.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Bizaxofusp?
Bizaxofusp (formerly MDNA55) is an investigational EGF-targeted immunotoxin designed for convection-enhanced delivery (CED) directly into brain tumors, particularly glioblastoma multiforme (GBM). It selectively targets EGFR-overexpressing tumor cells and delivers a potent cytotoxic payload. It is in late-stage clinical development for recurrent GBM.
What is Bizaxofusp used for?
Bizaxofusp is educationally associated with: Targeting EGFR-overexpressing solid tumors, Treatment of recurrent glioblastoma multiforme (GBM), Tumor debulking prior to additional therapy. Educational only — not medical advice.
How is Bizaxofusp administered?
Recorded routes of administration: Intratumoral.
What are the potential side effects of Bizaxofusp?
Reported adverse effects include: Headache, Seizures, Fatigue, Intracranial hemorrhage, Cerebral edema, Neurological deficits (focal). This list is not exhaustive — consult a qualified clinician.
Who should avoid Bizaxofusp?
Recorded contraindications: Hypersensitivity to Pseudomonas exotoxin components, Coagulopathy or bleeding diathesis, Active systemic infection, Poor performance status precluding neurosurgery. Consult a qualified clinician before use.