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BioNTech
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Updated Aug 28, 2026
BioNTech terminates Phase 2 CRC trial of autogene cevumeran as monotherapy after OS imbalance detected
BioNTech discontinued the Phase 2 BNT122-01 trial evaluating autogene cevumeran as a monotherapy adjuvant in Stage II-III colorectal cancer (CRC) on August 28, 2026, following a recommendation from the independent Data Safety Monitoring Board. The DSMB identified a numerical overall survival imbalance between treatment arms and concluded further trial continuation was unlikely to change the efficacy outcome, though no new safety signals emerged. The decision reflects the biological and immunological complexity of CRC as a cold tumor type resistant to monotherapy immunotherapy approaches, but does not affect the ongoing IMcode003 trial evaluating autogene cevumeran in combination with checkpoint inhibition and chemotherapy in pancreatic ductal adenocarcinoma (PDAC).
Tone: defensiveRevenue
€2.9B
BNTX 20-F · FY 2025 · EUR
Revenue FY2024
€2.8B
Founded
2008
Headquarters
Mainz, Germany
Profile
BNTX 20-F Item 4.B · Mar 10, 2026BioNTech SE is a global next-generation immunotherapy company focused on developing novel medicines against cancer, infectious diseases, and other serious conditions. The company combines mRNA technology, protein-based therapeutics including antibody-drug conjugates, and cell therapy platforms with integrated GMP manufacturing and AI-driven computational medicine capabilities. Its sole marketed product is Comirnaty, the first-ever approved mRNA vaccine, developed in partnership with Pfizer.
Read filing description ↓ Collapse description ↑
We are a global next-generation immunotherapy company aiming to pioneer novel medicines against cancer, infectious diseases and other serious diseases. Since our founding in 2008, we have focused on harnessing the power of the immune system to address human diseases with unmet medical needs and major global health burdens. Our fully integrated model combines decades of research in immunology with a multi-technology innovation engine, GMP manufacturing, translational drug discovery, clinical development, commercial capabilities, computational medicine, data science and artificial intelligence, or AI, and machine learning, or ML, capabilities to discover, develop and commercialize our marketed product and product candidates. We have built a broad toolkit across multiple technology platforms, including a diverse range of potentially first-in-class therapeutic approaches. This includes investigational messenger ribonucleic acid, or mRNA immunotherapies and protein-based therapeutics (including targeted antibodies such as monoclonal, bispecific and antibody-drug conjugates, or ADCs). Our primary focus is oncology, where we endeavor to address the full continuum of cancer from early to late disease stages. In infectious diseases, our goal is to develop vaccines and therapeutics caused by respiratory viruses, latent viruses, bacteria and parasites. Our approach has generated a robust and diversified product candidate pipeline across a range of technologies in oncology and infectious disease, and has led to the approval of our first marketed pharmaceutical product, Comirnaty.
Primary products
- Comirnaty (BNT162b2) – COVID-19 mRNA vaccine
- Pumitamig (BNT327/BMS986545) – bispecific immunomodulator targeting PD-L1 and VEGF-A
- Autogene cevumeran (RO7198457/BNT122) – individualized neoantigen specific immunotherapy (iNeST)
- Trastuzumab pamirtecan (BNT323/DB-1303) – HER2-directed ADC
- BNT324/DB-1311 – B7H3-directed ADC
- BNT325/DB-1305 – TROP2-directed ADC
End markets
Geographies
Named customers
Named competitors
“We maintained our leadership position in the global COVID-19 vaccine market, achieving a market share of over 50% during the fall 2025 vaccination season.” Competitive position, as stated in the filing
Revenue commentary · FY 2025
Reported in EUR. Total revenues increased from €2,751.1 million in 2024 to €2,869.9 million in 2025, driven by €613.0 million in revenues from out-licensing related to the BMS pumitamig collaboration, partially offset by an €436.8 million decline in COVID-19 vaccine revenues.
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