European Investor
22 Jan 2026, 10:39
BioNTech announced that the U.S. Food and Drug Administration has granted Fast Track designation to its investigational mRNA cancer immunotherapy candidate BNT113 for the treatment of HPV16-positive head and neck squamous cell carcinoma expressing PD-L1.
The designation is based on early safety and efficacy data from the ongoing Phase 2/3 AHEAD-MERIT trial, which is evaluating BNT113 in combination with pembrolizumab as a first-line therapy for patients with unresectable recurrent or metastatic disease. Fast Track status allows for more frequent interaction with the FDA and is intended to speed up development and regulatory review for therapies addressing serious conditions with unmet medical needs.
BioNTech said BNT113 targets HPV16-related tumors by inducing virus-specific anti-tumor immune responses, an area where no approved targeted treatments currently exist. The company highlighted head and neck cancer as a key focus within its oncology pipeline, as HPV-positive cases continue to rise globally and current treatment options offer limited long-term survival.
The designation is based on early safety and efficacy data from the ongoing Phase 2/3 AHEAD-MERIT trial, which is evaluating BNT113 in combination with pembrolizumab as a first-line therapy for patients with unresectable recurrent or metastatic disease. Fast Track status allows for more frequent interaction with the FDA and is intended to speed up development and regulatory review for therapies addressing serious conditions with unmet medical needs.
BioNTech said BNT113 targets HPV16-related tumors by inducing virus-specific anti-tumor immune responses, an area where no approved targeted treatments currently exist. The company highlighted head and neck cancer as a key focus within its oncology pipeline, as HPV-positive cases continue to rise globally and current treatment options offer limited long-term survival.
