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: 11 Mar 2025

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At a glance

Originator EMD Serono; Merck KGaA
Developer Bergonie Institute; EMD Serono; EMD Serono Research & Development Institute; GSK; M. D. Anderson Cancer Center; Merck KGaA; National Cancer Institute (USA); Precigen Inc; University of Hong Kong; Yonsei University
Class Antineoplastics; Immunotherapies; Monoclonal antibodies; 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.

No
New Molecular Entity Yes

Discontinued Anal cancer; Biliary cancer; Brain metastases; Breast cancer; Cervical cancer; Colorectal cancer; Gastric cancer; HER2 negative breast cancer; Malignant-mesothelioma; Nasopharyngeal cancer; Non-small cell lung cancer; Oropharyngeal cancer; Pancreatic cancer; Penile cancer; Prostate cancer; Rectal cancer; Recurrent respiratory papillomatosis; Small cell lung cancer; Soft tissue sarcoma; Solid tumours; Squamous cell cancer; Triple negative breast cancer; Urogenital cancer; Vulvovaginal cancer

26 Feb 2025 Updated efficacy and adverse events data from a phase II trial in Cancer released by PDS Biotech
18 Oct 2024 EMD Serono in collaboration with MD Anderson Cancer Center completes a phase-I clinical trials in HER2 positive cancer (First-line therapy, Neoadjuvant therapy) in USA (IV) (NCT03620201)
08 Oct 2024 National Cancer Institute completes a QuEST1 phase-I/II clinical trial in Prostate cancer (Combination therapy, Hormone-refractory, Late-stage disease) in the USA (PO) (NCT03493945)

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