Lorukafusp alfa

Fusion Protein / Bispecific Antibody Cytokine Conjugate (IL 2 Immunocytokine)Rx: InvestigationalCompound: Investigational

Also known as: Anti-CD8/IL-2 immunocytokine, CD8-IL2, RG6279

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

Summary

Lorukafusp alfa (also known as RG6279 or cergutuzumab amunaleukin-related compound) is an investigational IL-2-based immunocytokine being developed by Roche/Genentech. It is designed to selectively activate and expand CD8+ T cells and NK cells for anti-tumor immunity while reducing the systemic toxicity profile seen with conventional recombinant IL-2 (aldesleukin). It is under clinical investigation for solid tumors and hematologic malignancies.

Mechanism of Action

Lorukafusp alfa is a CD8-targeted IL-2 immunocytokine that selectively delivers interleukin-2 (IL-2) signaling to CD8+ T cells and NK cells via a bispecific fusion with an anti-CD8 antibody fragment, promoting selective expansion and activation of cytotoxic T lymphocytes while minimizing IL-2-related toxicities associated with non-targeted IL-2 receptor stimulation.

Routes of Administration

IntravenousSubcutaneous

Goals & Uses

  • T cell memory expansionImmunologyLow
  • Combination immunotherapyOncologyLow
  • Reduction of IL-2 systemic toxicitySafety / TolerabilityModerate
  • Anti-tumor immunity enhancementOncologyModerate

Contraindications

  • Severe autoimmune diseaseImmunologicalHigh
  • Severe organ dysfunctionOrgan FunctionModerate
  • Active severe infectionInfectiousHigh

Adverse Effects

  • Flu-like symptomsSystemic/ImmunologicalCommon
  • Lymphopenia / lymphocyte count changesHematologicalUncommon
  • Injection site reactionsLocalCommon
  • Cytokine release syndrome (CRS)ImmunologicalUncommon
  • Immune-related adverse events (irAEs)ImmunologicalUncommon
  • FatigueGeneralCommonLow energy or tiredness

Drug Interactions

  • Immunosuppressive agentsModerate
  • CorticosteroidsModerate
  • Anti-PD-1 / Anti-PD-L1 agentsModerate

Population Constraints

  • Transplant recipients on immunosuppressionMedical HistoryRelative
  • Pediatric patientsAgeRelative
  • Pregnant or breastfeeding womenReproductiveRelative
  • Patients with prior severe cytokine-mediated toxicityMedical HistoryRelative

Regulatory Status

  • European UnionInvestigationalClinical trials ongoing under EMA oversight; not approved.
  • United StatesInvestigationalUnder IND-enabled clinical trials; no FDA approval as of early 2025.
  • United KingdomInvestigationalNo MHRA approval; clinical investigation stage only.

Not approved by any regulatory authority as of early 2025. Under active clinical investigation (Phase I/II trials). Designated as investigational in the US, EU, and other jurisdictions.

Evidence & Sources

No sources recorded yet.

Browse All PeptidesBuild My Stack