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Bintrafusp alfa - EMD Serono/GlaxoSmithKline/Merck KGaA

Drug Profile

Bintrafusp alfa - EMD Serono/GlaxoSmithKline/Merck KGaA

Alternative Names: Anti-PD-L1/TGFbetaRII-fusion-protein; Anti-PDL1/TGFb Trap MSB0011359C; GSK-4045154; M-7824; MSB-0011359C

Latest Information Update: 07 Apr 2021

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At a glance

  • Originator EMD Serono; Merck KGaA
  • Developer EMD Serono; EMD Serono Research & Development Institute; GlaxoSmithKline; M. D. Anderson Cancer Center; Merck KGaA; National Cancer Institute (USA); Precigen Inc; University of Hong Kong
  • Class Antineoplastics; Bispecific antibodies; Immunotherapies; Recombinant fusion proteins
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Cytotoxic T lymphocyte stimulants; Natural killer cell stimulants; Programmed cell death-1 ligand-1 inhibitors; Transforming growth factor beta inhibitors
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Non-small cell lung cancer
  • Phase II/III Biliary cancer
  • Phase II Anal cancer; Breast cancer; Cervical cancer; Nasopharyngeal cancer; Oropharyngeal cancer; Penile cancer; Prostate cancer; Rectal cancer; Recurrent respiratory papillomatosis; Solid tumours; Squamous cell cancer; Vulvovaginal cancer
  • Phase I/II Brain metastases; Colorectal cancer; Pancreatic cancer; Small cell lung cancer
  • Phase I Urogenital cancer

Most Recent Events

  • 07 May 2021 Queen Mary University of London plans the phase II PEBBLE trial for Bladder cancer (Neoadjuvant therapy) in June 2021 (NCT04878250)
  • 05 May 2021 Merck KGaA plans the phase II TRUST trial for Soft tissue sarcoma (Late-stage disease, First-line therapy, Metastatic disease, Combination therapy, Unresectable/Inoperable) in France in December 2021 (IV, Infusion) (NCT04874311)
  • 08 Apr 2021 Yonsei University plans a phase Ib/II trial for Gastric cancer (Combination therapy, Metastatic disease, Late stage disease, Second-line therapy or greater) in South Korea (IV) (NCT04835896)
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