Advaxis, Inc. announced data from the investigator-initiated study evaluating the Company’s proprietary Lm-based antigen delivery product, axalimogene filolisbac (ADXS11-001), in combination with chemoradiation as a treatment for high-risk, locally advanced anal cancer. The Phase 1 study evaluated the safety and preliminary efficacy of the combination of ADXS11-001 with mitomycin, FU and intensity modulated radiation therapy in 10 patients with locally advanced, non-metastatic squamous cell anal cancer. Results showed that 9 patients achieved a complete response, and 8 patients (89%) remained disease free at a median follow-up of 42 months. One patient progressed, approximately 6 months post completion of study treatment and subsequently died from progressive disease, and one patient expired early in the study unrelated to study treatment. Treatment-related adverse events were consistent with the observed safety profile of ADXS11-001, and consisted of mostly grade 1-2 cytokine-release related events such as chills, headache and fever. Two patients experienced grade 3 treatment-related toxicities. There were no grade 4 events and ADXS11-001 did not cause any additive chemoradiation related toxicities. All adverse events occurred within 24 hours of treatment and resolved with standard care. These data show that ADXS11-001 can be safely administered with standard chemoradiation for patients with locally advanced, non-metastatic anal cancer.