ADXS-HPV: A therapeutic Listeria vaccination targeting cervical cancers expressing the HPV E7 antigen

Figures & data

Table 1. Listeria as anti-cancer therapy

Author	Year	Cancer Model	Investigational Agent	Outcomes
Pan et al.^24	1995	Colon, renal	Lm-NP^1	Protection against tumor load; regression of established tumors
Gunn et al.^33	2000	Cervical	Lm-LLO-E7	Recombinant Listeria vaccine secreting LLO-E7 fusion protein leads to tumor regression, while one secreting E7 does not; different immune responses detected between the 2 recombinant vaccines
Lin et al.^23	2002	Cervical	rLm-E7	Oral vaccination leads to immune response with vaccine efficacy
Sewell et al.^50	2004	Head and neck	Lm-ActA-E7	Tumor regression with T cell response
Singh et al.^25	2005	Breast	Lm-LLO-EC1 Lm-LLO-EC2 Lm-LLO-EC3 Lm-LLO-IC1 Lm-LLO-IC2	Efficacious anti-tumor agents, impact of agents abolished by absence of T cells
Kim et al.^26	2008	Breast	Lm-LLO-Mage-b	Reduction in metastatic disease
Sewell et al.^51	2008	Cervical	Lm-LLO-E7	Successful reduction in autochthonous tumor following vaccination
Seavey et al.^29	2009	Breast	Lm-hHer2-neu	Tumor regression; limited metastatic disease
Seavey et al.^27	2009	Breast	Lm-LLO-O-fetal liver kinase-1	Anti-angiogenesis vaccine effective without negatively impacting wound healing
Shahabi et al.^28	2011	Breast	ADXS-164	Highly attenuated recombinant Listeria vaccine without antibiotic selection markers remains efficacious
Wood et al.^31	2011	Breast	Lm-LLO-CD105A Lm-LLO-CD105B	Elicited anti-angiogenesis immune response effective against primary and metastatic cancer
Wood et al.^32	2012	Breast	Lm-LLO-ISG15	Reduction of tumor burden

¹ Influenza nucleoprotein

Table 2. Investigations of ADXS11-001 as anti-cancer therapy

Investigator	Cancer Model	Phase	Dosing Regimen	Enrollment (n)	Results
Maciag et al.^38	Cervical	I	Dose escalation scheme (1 × 10^9, 3.3 × 10^9, 1 × 10^10 CFU)	15	Dose limiting toxicity reached at 1 × 10^10 CFU
GOG^39	Cervical	II	1 × 10^9 CFU	67	Pending
Petit et al.^45	Cervical	II	1 × 10^9 CFU	100	36% 12 month survival, 11% response rate (preliminary)
Jones et al.^46,47	Oropharyngeal	I	Dose escalation scheme (3.3 × 10^8,1 × 10^9, 3.3 × 10^9 CFU)	36	Pending
Safran et al.^48,49	Anal	I/II	1 × 10^9 CFU	25	Pending

Table 3. Most frequent adverse events in Phase I trial assessing safety of ADXS11-011³⁸

Adverse Event (AE)	Reported percentage (%)	Adverse Event (AE)	Reported percentage (%)
Pyrexia	100	Chills	53.3 each
Vomiting	60	Headache
Nausea	46.7 each	Anemia
Tachycardia		MS* pain	56.7

* Musculoskeletal

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