Abstract
Survival of patients with advanced, recurrent, or metastatic human papillomavirus (HPV)-associated cancer is suboptimal despite the availability of various treatment modalities. The recently developed bacterial vector
Listeria monocytogenes
(
Lm
) activates innate and adaptive immune responses and is expected to offer immunologic advantages. Axalimogene filolisbac (AXAL or ADXS11–001) is a novel immunotherapeutic based on the live, irreversibly attenuated
Lm
fused to the nonhemolytic fragment of listeriolysin O (
Lm
-LLO) and secretes the
Lm
-LLO-HPV E7 fusion protein targeting HPV-positive tumors. Herein are reported the development and recent results of various clinical trials in patients with HPV-associated cervical, head and neck, and anal cancers.