January 26, 2018 — Advaxis Inc. (NASDAQ:ADXS), a late-stage biotechnology immunotherapy company announced that data from the investigator-initiated study of the company’s proprietary Lm-based antigen delivery product, in combination with chemoradiation as a treatment for high-risk, locally advanced anal cancer were published in the International Journal of Radiation Oncology. The abstract is available online here.
The Phase 1 study of axalimogene filolisbac (ADXS11-001), led by Howard Safran, M.D., at Brown University, evaluated the safety and preliminary efficacy of the combination of ADXS11-001 with mitomycin, FU and intensity modulated radiation therapy (IMRT) 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 percent) 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.
For more information: www.advaxis.com
May 03, 2025 
