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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: 21 Jul 2025

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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

  • Phase III Non-small cell lung cancer
  • Phase II Endometrial cancer; Malignant melanoma
  • Phase I/II Solid tumours

Most Recent Events

  • 07 Jul 2025 Phase-II clinical trials in Malignant melanoma (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater, Monotherapy) in Puerto Rico (IV) (NCT06984328) (EUCT2025-520468-1)
  • 07 Jul 2025 Phase-II clinical trials in Malignant melanoma (Second-line therapy or greater, Late-stage disease, Inoperable/Unresectable, Metastatic disease, Combination therapy) in Puerto Rico (IV) (NCT06984328) (EUCT2025-520468-1)
  • 22 May 2025 Genmab plans a phase II ABBIL1TY MELANOMA-07 trial for Melanoma (Monotherapy, Combination therapy, Late-stage disease, Second-line therapy or greater, Inoperable/Unresectable, Metastatic disease) in June 2025 (IV) (NCT06984328)

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