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Bintrafusp alfa - EMD Serono/Merck

Drug Profile

Bintrafusp alfa - EMD Serono/Merck

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

Latest Information Update: 14 Jan 2023

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At a glance

  • Originator EMD Serono; Merck KGaA
  • Developer Bergonie Institute; 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; 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 Biliary cancer; Breast cancer; Cervical cancer; Non-small cell lung cancer
  • Phase II Anal cancer; Nasopharyngeal cancer; Oropharyngeal cancer; Penile cancer; Prostate cancer; Rectal cancer; Recurrent respiratory papillomatosis; Soft tissue sarcoma; Solid tumours; Squamous cell cancer; Vulvovaginal cancer
  • Phase I/II Brain metastases; Colorectal cancer; Pancreatic cancer; Small cell lung cancer
  • Phase I Urogenital cancer
  • No development reported HER2 negative breast cancer

Most Recent Events

  • 10 Nov 2022 Merck Biopharma completes a phase-II/III clinical trial in Biliary cancer (Combination therapy, First-line therapy, Late-stage disease, Metastatic disease) in USA, Argentina, Australia, Brazil, Chile, China, France, Germany, Italy, Japan, South Korea, Poland, Spain, Taiwan, UK (NCT04066491) (JapicCTI194961)
  • 30 Sep 2022 Merck KGaA and EMD Serono completes a phase II trial in Biliary tract cancer (Late-stage disease; Metastatic disease; Monotherapy; Second-line therapy or greater) in USA, China, France, Italy, Japan, Spain, South Korea, Taiwan and the UK (IV) (NCT03833661) (EudraCT2018-003707-19)
  • 09 Sep 2022 Initial adverse events, efficacy and pharmacokinetics data from a phase I trial in Solid tumours presented at the 47th European Society for Medical Oncology Congress (ESMO-2022)
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