Advaxis Presents Lm-LLO Cancer Immunotherapy Data at the 2015 American Association for Cancer Research Meeting

Advaxis, Inc.

, a cancer immunotherapy company, today announced the data of one clinical and two preclinical studies highlighting the survival outcomes and anti-tumor effects of its proprietary Lm-LLO cancer immunotherapy technology at the American Association for Cancer Research (AACR) Annual Meeting 2015, held April 18 – 22 in Philadelphia, Pennsylvania. On Tuesday, April 21, Samir Khleif, M.D., Director of the State of Georgia Cancer Center, Georgia Regents University Cancer Center (GRU), presented on a preclinical study evaluating the therapeutic potential of ADXS-HPV in combination with anti-OX40 and anti-GITR antibodies (Poster Board #13; Abstract #LB-229). The data demonstrated that the combination of therapies led to significant inhibition of tumor growth and prolonged survival in tumor bearing mice. Complete regression of established tumors occurred in 40% and 60% of animals treated with ADXS-HPV in combination with anti-OX40 and anti-GITR antibodies, respectively. On Monday, April 20, Nicola J. Mason, BVetMed, Ph.D., DACVIM, Assistant Professor of Medicine, University of Pennsylvania's School of Veterinary Medicine, presented preliminary data from an ongoing Phase 1 clinical study of 10 companion dogs with osteosarcoma (Poster Board #7; Abstract #LB-113). The data suggests that ADXS-HER2 in combination with palliative radiation delayed tumor progression and prolonged overall survival in pet dogs with spontaneous osteosarcoma that were not candidates for primary tumor removal (amputation). Repeat doses of ADXS-HER2 were well tolerated with no systemic or cardiac toxicity. Additionally, the combination treatment was found to maintain or improve limb function and quality of life over the study period. Five of the treated dogs remain alive, with a median survival, to date, of all 10 study dogs reported at 285 days, which compares favorably to historical median survival time of 136 days in dogs treated with palliative radiation only. Poonam Molli, Ph.D., Senior Scientist, Advaxis, Inc., also presented on Monday, April 20, on a preclinical study evaluating the therapeutic potential of ADXS-HPV in combination with anti-PD-L1 antibody in mice (Poster Board #25 Abstract #2513). The data indicated that co-administration of ADXS-HPV with anti-PD-L1 antibody demonstrated an improved ability to control tumor growth compared with anti-PD-L1 antibody therapy alone. The combination was well tolerated with no added toxicities. Daniel J. O'Connor, Chief Executive Officer of Advaxis, stated, "The studies presented at AACR showcase the diverse range of Advaxis's novel immunotherapies and the abundance of potential that our Lm-LLO technology platform enables in combination with complimentary technologies, including anti-PD-L1 immune checkpoint inhibitors and anti-OX40 and anti-GITR antibodies. Advaxis believes that it is at the forefront of innovation in the immunotherapy space, and the data presented at AACR suggest that our Lm-LLO technology platform offers significant opportunity to address a number of cancer needs and indications." Robert Petit, Ph.D., Chief Scientific Officer of Advaxis, stated, "Dr. Mkrtichyan and Dr. Khleif's data on the combination of agnostic co-stimulatory antibodies OX40 and GITR with our Lm-LLO immunotherapy reflects the potential for promising improvements in survival in this model. We believe these findings may be directly translatable to clinical investigations in patients. The Phase 1 safety and efficacy data with ADXS-HER2 in canine osteosarcoma supports and informs our clinical development program for ADXS-HER2 in HER2 expressing cancers, such as osteosarcoma, breast, gastric and esophageal cancers. It is the first clinical demonstration of the preclinical synergy between hypofractionated radiation therapy and Advaxis Lm-LLO immunotherapy. These data also support further development of a potential treatment option for osteosarcoma in dogs that does not include amputation or chemotherapy. Lastly, Advaxis's preclinical research with ADXS-HPV in combination with anti-PD-L1 antibodies highlights the potential that we foresee in our combination studies with MedImmune's MEDI4736." The three poster presentations are available on Advaxis's corporate website: http://www.advaxis.com/technology/scientific-presentations. Additionally the posters will be showcased during Advaxis's Research Reception at the AACR Annual Meeting 2015 being held at The Ritz-Carlton, Philadelphia, at 6:30 p.m., EDT. Details about the event and registration information are available via Advaxis's corporate website: http://www.advaxis.com.