First Human Patient Treated in Phase 1b Study of Advaxis's ADXS-HER2 in HER2 Expressing Solid Tumors

Dose escalation portion of study will investigate safety and tolerability of ADXS-HER2 as monotherapy
Maximum tolerated dose may translate into pivotal trial in pediatric osteosarcoma
PRINCETON, NJ, USA I September 28, 2015 I Advaxis, Inc. (ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced that the first patient was treated in a Phase 1b dose-escalation clinical study of ADXS-HER2 for the treatment of patients with metastatic HER2 expressing solid tumors.

The Phase 1b clinical trial is the first-in-human study of Advaxis's lead Lm Technology(TM) immunotherapy product for HER2 expressing cancers. The dose escalation portion of the study will investigate the safety and tolerability of ADXS-HER2 as a monotherapy in approximately 18 patients diagnosed with metastatic HER2 expressing solid tumors, which include breast, gastric, esophageal and osteosarcoma. Once the maximum tolerated dose (MTD) and recommended Phase 2 dose have been identified, up to 80 patients may be enrolled in up to four HER2 expressing tumor specific cohorts in the expansion phase of the study.

"We are pleased to enroll our first patient in the dose escalation portion of this Phase 1b study of ADXS-HER2 in HER2 expressing solid tumors," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "With the initiation of this study, we now have three clinical constructs in development and seven ongoing clinical trials, which reinforce our long-term commitment to evaluate the potential of our immunotherapy platform across different tumor types."

Advaxis plans to establish the MTD from the Phase 1b study in pediatric patients and work with Children's Oncology Group (COG) to potentially launch a pivotal trial in pediatric osteosarcoma in 2016. The COG, a National Cancer Institute supported clinical trials group, is the world's largest organization devoted exclusively to childhood and adolescent cancer research.

This Phase 1b study builds upon efficacy and safety data from Phase 1 clinical studies of ADXS-HER2 conducted in dogs with osteosarcoma, which may have important translational relevance for human patients with osteosarcoma and other HER2 expressing cancers. Preliminary data from a Phase 1 clinical trial in canine osteosarcoma presented at the 2014 American College of Veterinary Internal Medicine (ACVIM) Forum suggested ADXS-HER2 safely delayed or prevented the development of metastatic disease and prolonged overall survival in pet dogs with osteosarcoma when administered after amputation and chemotherapy. Results from this trial led to ADXS-HER2 being considered by the U.S. Department of Agriculture (USDA) for expedited approval to treat canine osteosarcoma. Furthermore, preliminary data from a second ongoing canine Phase 1/2 trial presented at the 2015 American Association for Cancer Research (AACR) Annual Meeting suggested that ADXS-HER2 in combination with palliative radiation delayed tumor progression and prolonged overall survival in pet dogs with spontaneous osteosarcoma that are not candidates for primary tumor removal (amputation).

"The Phase 1 safety and efficacy data with ADXS-HER2 in canine osteosarcoma supports our clinical development of ADXS-HER2 in HER2 expressing solid tumors," said David J. Mauro, M.D., Ph.D., Executive Vice President and Chief Medical Officer of Advaxis. "We look forward to translating this canine evidence into the first human trial of ADXS-HER2 in metastatic HER2 expressing solid tumors."

About HER2 Expressing Solid Tumor Cancers

Human epidermal growth factor receptor 2 (HER2) is overexpressed in a percentage of solid tumors such as breast, gastric, bladder, brain, pancreatic, ovarian and bone cancer (osteosarcoma). The American Cancer Society estimates that in 2015 in the United States alone there will be 231,840 new cases of invasive breast cancer; 24,590 new cases of gastric cancer; 74,000 new cases of bladder cancer; 22,850 new cases of brain/spinal cancer; 48,960 new cases of pancreatic cancer; 21,290 new cases of ovarian cancer; and 800 new cases of osteosarcoma. HER2 expression is associated with more aggressive disease, increased risk of relapse and decreased overall survival, and is an important target for immunotherapy.


ADXS-HER2 is an Lm Technology(TM) immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal-health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology(TM). The Lm Technology(TM), using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology(TM) immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products, ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. For additional information on Advaxis, visit and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

SOURCE: Advaxis