BioNTech’s investigational mRNA immunotherapy BNT113 receives FDA Fast Track designation for first-line treatment of PD-L1–expressing HPV16-positive head and neck squamous cell carcinoma.
Written By: Pharmacally Medical News Desk
BioNTech SE’s investigational mRNA cancer immunotherapy BNT113 has received Fast Track designation from the U.S. Food and Drug Administration (FDA), marking an important regulatory milestone for patients with HPV16-positive head and neck squamous cell carcinoma (HNSCC). The designation applies to patients with unresectable recurrent or metastatic disease whose tumors express PD-L1, a population with limited effective treatment options.
Addressing a clear unmet need in HPV16-positive HNSCC
HNSCC is the seventh most common cancer worldwide, and its global incidence continues to rise. Roughly one third of cases are linked to human papillomavirus infection, with HPV16 responsible for the majority, particularly in oropharyngeal cancers. Despite the distinct biology of HPV-driven tumors, there are currently no approved therapies that directly target HPV16 in this setting. Many patients progress on standard treatments, with reported median overall survival of just under two years, underscoring the need for new, more effective approaches.
What is BNT113?
BNT113 is an investigational mRNA-based cancer immunotherapy designed to target the viral drivers of disease. It encodes the HPV16 E6 and E7 oncoproteins, which are commonly expressed in HPV16-positive solid tumors and play a central role in tumor growth and survival. By delivering mRNA instructions for these antigens, BNT113 aims to stimulate a targeted immune response against HPV16-expressing cancer cells.
The therapy is intended to work alongside immune checkpoint inhibition. By priming HPV16-specific T-cell responses, BNT113 may enhance the effectiveness of standard PD-1 blockade and improve anti-tumor activity without adding traditional chemotherapy.
Clinical development and FDA Fast Track status
The FDA’s Fast Track designation is based on preliminary safety and efficacy data from the ongoing pivotal Phase 2/3 AHEAD-MERIT trial (NCT04534205). This study is evaluating BNT113 in combination with pembrolizumab compared with pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic HPV16-positive, PD-L1–expressing HNSCC.
Fast Track status is intended for therapies that treat serious conditions and have the potential to address unmet medical needs. It allows for more frequent interactions with the FDA, rolling review of regulatory submissions, and the possibility of an expedited review pathway if clinical results continue to support benefit.
Strategic importance for BioNTech
Head and neck cancer is one of BioNTech’s core oncology focus areas. The Fast Track designation for BNT113 strengthens the company’s mRNA oncology portfolio and highlights the broader potential of mRNA platforms beyond infectious diseases. If successful, BNT113 could become the first HPV-targeted, chemotherapy-free immunotherapy option for patients with HPV16-positive HNSCC.
References
BioNTech Receives FDA Fast Track Designation for mRNA Cancer Immunotherapy Candidate BNT113 in HPV16+ Head and Neck Cancer, 21 January 2026, BioNTech Receives FDA Fast Track Designation for mRNA Cancer Immunotherapy Candidate BNT113 in HPV16+ Head and Neck Cancer | BioNTech
A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 (AHEAD-MERIT), ClinicalTrials.gov ID NCT04534205, https://clinicaltrials.gov/study/NCT04534205