Investing.com --BioNTech (NASDAQ: BNTX) shares fell 5% on Tuesday after the company announced that a mid-to-late-stage clinical trial for its experimental mRNA cancer drug, BNT113, missed its first major goal.

The study tested BNT113 in combination with an existing immunotherapy drug (pembrolizumab) as a primary treatment for patients with advanced, HPV-linked head and neck cancer. Researchers found that adding the experimental mRNA drug did not significantly increase the amount of time patients lived without their cancer worsening, compared to using the existing treatment alone. (About one-third of head and neck cancers are associated with human papillomavirus, or HPV).

Despite missing this initial target, independent trial monitors recommended continuing the study to evaluate its second main objective: whether the drug combination improves overall survival time.

Under the trial’s design, if the treatment ultimately extends how long patients live overall, the study will still be considered a success. BioNTech does not have access to the ongoing trial data to ensure the final results remain unbiased.

"The potential of mRNA cancer treatments lies in their ability to trigger immune responses that can provide long-lasting benefits and, ultimately, prolong patients’ lives," said Prof. Özlem Türeci, Co-Founder and Chief Medical Officer at BioNTech. She noted that because the body’s immune response builds over time, evaluating the final overall survival data will be critical to understanding the treatment’s true potential.

BNT113 is designed to specifically seek out and target the HPV virus within tumor cells. Currently, there are no approved cancer treatments that specifically target HPV

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