BioNTech CEO Ugur Sahin cited extensive evidence supporting the clinical benefit of COVID-19 vaccines, highlighting a recent real-world study from France of about 27 million adults. The company said the study, which compared roughly 22 million vaccinated adults with 5 million unvaccinated adults, found reduced overall mortality and more than a 70% reduction in COVID-associated mortality, including in adults aged 18 to 50.
Looking ahead to 2026, Sahin outlined three priorities: accelerate late-stage development of the initial wave of oncology assets, build momentum through multiple combination strategies, and shift from a platform-centric to a tumor-centric clinical development approach.
BioNTech described its oncology strategy as synergy-driven across three modalities: next-generation immunomodulators, targeted therapies with a focus on antibody-drug conjugates (ADCs), and mRNA cancer immunotherapies, including fixed combinations and personalized mRNA vaccines. The company said combining these modalities could help prevent or overcome resistance, enable more durable responses, and reduce execution risk through diversification and partnerships.
Prometimic, a PD-L1/VEGF Fc-silenced bispecific developed with Bristol Myers Squibb, is designed to deliver dual blockade of VEGF and PD-L1. BioNTech said preclinical data suggest the molecule increases PD-L1 internalization and has shown efficacy signals across indications regardless of PD-L1 expression. The company expects eight pivotal studies with BMS to be ongoing by the end of 2026. In a recent global phase II program, Prometimic reportedly achieved an 85% objective response rate in first-line small cell lung cancer and a 70% objective response rate in triple-negative breast cancer. BioNTech also cited data reproducing results from a China study showing a progression-free survival of 13 months and overall survival in the 20+ month range in low PD-L1 triple-negative breast cancer, and said clinical benefit rates of 80%–100% were seen in more than 10 indications combining Prometimic with chemotherapy.
Gotistobart, a CTLA-4–targeting program partnered with OncoC4, is designed to selectively deplete regulatory T cells in the tumor microenvironment. BioNTech reported data from more than 1,000 patients and said Gotistobart is in pivotal development for second-line squamous non-small cell lung cancer and recently received FDA orphan drug designation. An unblinded stage 1 analysis from a phase III study reportedly showed a 54% reduction in the risk of death versus docetaxel. The first interim efficacy readout is expected in 2026.
BNT324/DB-1311, a B7-H3 ADC developed with Duality, has shown pan-tumor activity and a favorable safety profile in early studies. BioNTech said the program is being evaluated in more than 10 indications, with low single-digit rates of grade 3 treatment-related adverse events and low rates of ILD pneumonitis; some patients have been treated for a year or longer. The company highlighted metastatic castration-resistant prostate cancer as an area of interest and said a phase III first-line trial in mCRPC is planned, with an IND cleared and recruitment expected to start in the coming months.
BioNTech expects about 15 phase III readouts across 2026 and 2027 and described 2026 as “packed” with catalysts. Five late-stage readouts expected in 2026 include a HER2 ADC program (TPAM), Gotistobart, BNT113 (an HPV vaccine candidate for head and neck cancer), Prometimic data from a Chinese triple-negative breast cancer study, and a personalized vaccine trial in high-risk colorectal cancer. The company also anticipates more than 15 total data readouts when early-stage combination data are included.
Chief Financial Officer Ramón Zapata said BioNTech’s primary use of cash will be to continue developing its internal pipeline and grow organically until there is greater visibility on future revenues from late-stage assets and combinations. A secondary priority is inorganic acquisitions or collaborations, with other potential uses of cash to be considered as launch timing and opportunity size become clearer.
BioNTech SE, founded in 2008 and headquartered in Mainz, Germany, develops immunotherapies and vaccines with a primary focus on mRNA technology. The publicly traded company (NASDAQ: BNTX) became widely known for its rapid development and global deployment of an mRNA-based COVID-19 vaccine in collaboration with Pfizer. BioNTech’s core activities include discovery research, clinical development and manufacturing of mRNA-based medicines, personalized cancer immunotherapies, engineered cell therapies, and antibody- and protein-based therapeutics.
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