BioNTech SE announced that the FDA has granted Fast Track designation to BNT113, an investigational mRNA cancer immunotherapy, for the treatment of patients with human papillomavirus type 16 positive (“HPV16+”) head and neck squamous cell carcinoma (“HNSCC”) expressing PD-L1, a distinct cancer type associated by infection with high-risk human papillomavirus.
The designation has been granted based on preliminary safety and efficacy data from the ongoing pivotal Phase 2/3 AHEAD-MERIT clinical trial (NCT04534205) evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1.
HNSCC is the seventh most common cancer type worldwide with increasing global incidence, mainly driven by a rise in HPV16-related oropharyngeal tumors, the most common subtype of HNSCC. About one third of HNSCC cases are HPV-positive following a HPV infection, with a rising trend, of which about 90% of oropharyngeal cancers are driven by the subtype HPV16. Despite the distinct characteristics of HPV-positive tumors, there are currently no HPV-targeted treatments approved. Many patients with HPV16+ HNSCC experience disease progression under current standard of care treatments with a median overall survival of 20.7 months, underlining the unmet medical need for novel HPV-targeted chemotherapy-free treatment options that improve long-term survival. HNSCC is among BioNTech's key tumor areas.
BNT113 is an investigational mRNA cancer immunotherapy encoding the E6 and E7 proteins of HPV16, that are frequently found in HPV16+ solid tumors. This mRNA cancer immunotherapy approach is designed to induce HPV16-specific anti-tumor immune responses, thereby aiming to enhance clinical responses in patients being treated with checkpoint inhibitor standard of care treatment.
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