On December 09, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported that it will present a poster on Advaxis’s Lm Technology cancer immunotherapy ADXS-HER2 at the 2015 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas during Poster Session 1 on Wednesday, December 9, 2015, from 5-7 p.m. CST (Press release, Advaxis, DEC 9, 2015, View Source [SID:1234508514]).
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"Standard treatments for metastatic HER2-positive breast cancer are effective, but resistance develops and different approaches are needed," said Antoinette R. Tan, M.D., M.H.Sc., Chief of Breast Medical Oncology at Levine Cancer Institute, Carolinas HealthCare System, Charlotte, N.C. "This Phase 1b trial tests the approach of using an attenuated bacteria that has been shown in preclinical studies to disable the tumor’s ability to hide from and resist therapy, potentially offering a novel therapeutic strategy for patients with HER2-positive tumors."
The poster, titled "A multicenter, Phase 1b, first-in-human dose-escalation study of ADXS31-164, a listeria monocytogenes-LLO immunotherapy, in patients with HER2-expressing solid tumors," will be presented by Dr. Tan. As of October 20, 2015, this study has enrolled three patients.
The Phase 1b study in humans 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 companion dogs with spontaneous osteosarcoma showed that administration of ADXS-HER2 following amputation and chemotherapy was safe and induced immune responses against HER2 expressing tumors in 15 out of 18 dogs. Median survival times for ADXS-HER2 treated dogs and a matched historical control group were 956 days and 423 days respectively. Overall survival rates at 1 and 2 years for dogs treated with ADXS-HER2 were 77.8 percent and 67 percent respectively and 55 percent and 28 percent respectively for the historical control group. Based on these encouraging results, ADXS-HER2 is being considered for expedited approval in 2016 by the U.S. Department of Agriculture (USDA) to treat canine osteosarcoma.
Furthermore, preliminary data from a second ongoing canine Phase 1/2 trial suggests that ADXS-HER2 in combination with palliative radiation may delay primary and metastatic tumor progression and prolong overall survival in a subset of pet dogs with spontaneous osteosarcoma that do not undergo amputation or chemotherapy.
The European Medicines Agency (EMA) recently granted Orphan Drug Designation for ADXS-HER2 for the treatment of osteosarcoma in humans.
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 pediatric 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 207 new cases of pediatric osteosarcoma. HER2 expression is associated with more aggressive disease, increased risk of relapse and decreased overall survival, and is an important target for immunotherapy.
About ADXS-HER2
ADXS-HER2 is an Lm Technology 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) and the European Medicines Agency (EMA) 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.
Clinical trials of ADXS-HER2 have been placed on clinical hold by the FDA. Advaxis is working closely with the FDA and expects this clinical hold will be resolved expeditiously.