BioNTech Reports AHEAD-MERIT Phase 2/3 Clinical Trial Did Not Meet First Dual Primary Endpoint Of Progression-Free Survival For mRNA Cancer Immunotherapy Candidate BNT113 Plus Pembrolizumab Compared With Pembrolizumab Alone

• AHEAD-MERIT Phase 2/3 clinical trial did not meet its first dual primary endpoint of progression-free survival for the mRNA cancer immunotherapy candidate BNT113 plus pembrolizumab compared with pembrolizumab alone 
• The trial will continue to evaluate the second dual primary endpoint of overall survival completing the assessment with the potential of this treatment approach to help patients live longer
• Under the trial’s pre-specified statistical design, a statistically significant improvement in overall survival would establish a positive trial outcome, even if the progression-free survival dual primary endpoint was not met
• mRNA cancer immunotherapies are a key pillar of BioNTech’s oncology strategy, which includes novel treatment combinations to maximize the potential of its diversified oncology pipeline and elevate treatment outcomes for patients

MAINZ, Germany, October 13, 2026 – BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) today announced the first topline results from the AHEAD-MERIT Phase 2/3 clinical trial (NCT04534205) for its investigational mRNA cancer immunotherapy BNT113 (tenumomeran/raplemomeran or "tenu-ra").

The clinical trial is evaluating BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy as a first-line treatment for patients with unresectable recurrent or metastatic human papillomavirus 16-positive ("HPV16+") head and neck squamous cell carcinoma ("HNSCC") expressing PD-L1. Approximately one third of HNSCC cases are associated with HPV infection. The majority are linked to HPV16, one of the most common, high-risk HPV types associated with cancer. 

The Phase 3 part of AHEAD-MERIT has dual primary endpoints, progression-free survival ("PFS") and overall survival ("OS"), providing complementary measures of clinical benefit. At the analysis for PFS, BNT113 in combination with pembrolizumab did not demonstrate a statistically significant improvement in PFS versus pembrolizumab alone. The Independent Data Monitoring Committee ("IDMC") has recommended that the clinical trial continues as planned to evaluate the second primary endpoint of OS to complete the assessment of the potential of this approach to help patients live longer. Under the trial’s pre-specified statistical design, a statistically significant improvement in overall survival would establish a positive trial outcome, even if the PFS dual primary endpoint was not met. BioNTech remains blinded to ongoing trial data in accordance with the trial’s governance procedures.

Despite the distinct characteristics of HPV-positive tumors, there are currently no HPV-targeted treatments approved. Many patients with HPV16+ HNSCC experience disease progression with current standard-of-care treatments, underscoring the continued need for novel HPV-targeted options that improve long-term survival. The investigational mRNA cancer immunotherapy BNT113 encodes a fixed set of antigens to specifically target two HPV16-derived antigens that are frequently expressed on HPV16+ tumor cells.

BioNTech’s mRNA-based cancer immunotherapies are a key pillar of its oncology strategy, which includes novel treatment combinations to maximize the potential of its diversified oncology pipeline and elevate treatment outcomes for patients.