Clinical study data of Advaxis' Lm-LLO immunotherapies to be presented at SITC Annual Meeting

Nov 5 2014

Advaxis, Inc. (NASDAQ:ADXS), a cancer immunotherapy company, today announced the abstracts of three preclinical and clinical studies highlighting the survival outcomes and anti-tumor effects of its proprietary Lm-LLO cancer immunotherapy technology at the Society for Immunotherapy of Cancer (SITC) 29^th Annual Meeting, November 6-9, 2014 at the Gaylord National Hotel and Convention Center in National Harbor, Maryland.

Daniel J. O’Connor, Chief Executive Officer of Advaxis, stated:

The studies being presented at SITC demonstrate the potential that our Lm-LLO immunotherapies offer in the treatment of a wide range of cancers and, collectively, the value that Advaxis is continuing to build as a company.

O’Connor continued:

Of note, the data from Dr. Mason’s research in canine osteosarcoma supports our rational to pursue a clinical development program with ADXS-cHER2 in pediatric osteosarcoma, based on the known similarities between canine and human osteosarcoma, as well as other HER2 overexpressing cancers, such as breast, gastric, and esophageal cancers. Meanwhile, the Phase 2 data with ADXS-HPV supports further development of this Lm-LLO immunotherapy. Additionally, Advaxis’s preclinical research with bivalent constructs demonstrates the ability of the platform to address multiple targets within the same Lm-LLO cancer immunotherapy and lays the groundwork to potentially expand our pipeline.

On Friday, November 7, Nicola J. Mason, BVetMed, Ph.D., DACVIM, and Pamela Cole, Chair in Companion Animal Medicine, Assistant Professor of Medicine, University of Pennsylvania's School of Veterinary Medicine, will present the preliminary data from an ongoing Phase 1 clinical study in dogs with osteosarcoma (poster #69). The data indicates that ADXS-cHER2 is able to delay or prevent metastatic disease, with all 17 treated dogs failing to develop lung metastasis. Additionally, ADXS-cHER2 has been found to significantly prolong overall survival following standard of care (amputation and follow-up chemotherapy). 14 of the treated dogs remain alive with median survival having not yet been reached; median survival in control dogs (n=13) was 316 days.

Anu Wallecha, Ph.D., Director Research and Development at Advaxis, will be also be delivering a poster presentation on Friday, November 7, on a preclinical study evaluating the therapeutic efficacy of two bivalent Lm-LLO immunotherapies (HER2/HMW-MAA and HER2/CA9) in comparison to monovalent Lm-LLO immunotherapies (poster #77). The poster will also provide possible mechanisms of action that could be responsible for the observed anti-tumor effects.

On Saturday, November 8, Robert Petit, Ph.D., Chief Scientific Officer of Advaxis, will present data that was previously reported at ASCO 2014 on the final results from the randomized Phase 2 clinical study of 110 patients with recurrent cervical cancer treated with a single cycle (three doses) of ADXS-HPV (poster #106). Long-term survival was 18% >24 months, 18 month survival was 22%, and 12 month survival was 32%. The overall tumor response rate was 11% (complete and partial responses), with a median duration of response of 9.5 months. A disease control rate (≥ three months) was observed for 38% of patients. ADXSHPV was well-tolerated with 62% of patients reporting no adverse events (AE) and 38% of patients reporting mild transient adverse events (Grade 1 or 2) that occurred on the day of infusion. One Grade 3 fever was reported and there were no Grade 4 or Grade 5 AE.