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Acasunlimab - BioNTech/Genmab

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Drug Profile

Acasunlimab - BioNTech/Genmab

Alternative Names: BNT-311; DuoBody-PD-L1x4-1BB; GEN-1046; PD-L1x4-1BB

Latest Information Update: 16 Jan 2026

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At a glance

  • Originator BioNTech; Genmab
  • Class Antineoplastics; Bispecific antibodies; Immunotherapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; CD137 antigen agonists; Programmed cell death-1 ligand-1 inhibitors; T lymphocyte stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Discontinued Endometrial cancer; Malignant melanoma; Non-small cell lung cancer; Solid tumours

Most Recent Events

  • 16 Jan 2026 Discontinued - Phase-II for Malignant melanoma (Late-stage disease, Inoperable/Unresectable, Second-line therapy or greater, Monotherapy, Metastatic disease) in USA (IV)
  • 16 Jan 2026 Discontinued - Phase-II for Malignant melanoma (Second-line therapy or greater, Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in USA (IV)
  • 12 Jan 2026 Phase-II clinical trials in Malignant melanoma (Late-stage disease, Metastatic disease, Combination therapy, Inoperable/Unresectable, Second-line therapy or greater) in USA (IV) (NCT06984328)

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