Phase I study evaluating high dose ADXS11-001 treatment in women with carcinoma of the cervix.

Immune responses to the facultative intracellular bacterium Listeria monocytogenes (Lm) are robust and well characterized. Utilized for decades as a model of host-disease immunology, Lm is well suited for use as an immunotherapeutic bacterial vector for the delivery of foreign antigen. Genetic modification of Lm has been undertaken to create an attenuated organism that is deficient in its master transcriptional regulator, protein-related factor A, and incorporates a truncated, nonhemolytic version of the listeriolysin O (LLO) molecule to ensure its adjuvant properties while also preventing escape of the live organism from the phagolysosome. Delivery of a vaccine construct (Lm-LLO-E7; axalimogene filolisbac [AXAL] or ADXS11-001) in which the modified LLO molecule is fused with the E7 oncoprotein of human papillomavirus type 16 (HPV-16) consistently stimulates strong innate and E7 antigen-specific adaptive immune responses, resulting in reduction of tumor burden in animal cancer models. In the clinical setting, AXAL has shown early promise in phase I/II trials of women with cervical cancer, and several more trials are currently underway to assess the efficacy and safety of this antitumor vaccine in patients with HPV-positive head and neck and anal cancers.

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Therapeutic options for treatment of human papillomavirus-associated cancers - novel immunologic vaccines: ADXS11–001

Miles

Safran

Monk

2017

gynaecol oncol res pract

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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.

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Phase I study evaluating high dose ADXS11-001 treatment in women with carcinoma of the cervix.

Cited by 3 publications

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ADXS11-001 LM-LLO as specific immunotherapy in cervical cancer

ADXS11-001 LM-LLO as specific immunotherapy in cervical cancer

Mechanistic insights into ADXS11-001 human papillomavirus-associated cancer immunotherapy

Therapeutic options for treatment of human papillomavirus-associated cancers - novel immunologic vaccines: ADXS11–001

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