Company Overview of Advaxis, Inc.
Advaxis, Inc., a clinical stage biotechnology company, focuses on the discovery, development, and commercialization of Lm-LLO cancer immunotherapies in the United States. The Lm-LLO immunotherapy platform technology stimulates the immune system to induce antigen-specific anti-tumor immune responses involving innate and adaptive arms of the immune system by inhibiting the T-cells, tregs, and myeloid-derived suppressor cells, and MDSC to promote immunologic tolerance of cancer cells in the tumor. Its lead product ADXS-HPV, an Lm-LLO immunotherapy product candidate used for the treatment of human papilloma virus (HPV) associated cancers, completed its Phase II study. The company is also develop...
305 College Road East
Princeton, NJ 08540
Founded in 2002
Key Executives for Advaxis, Inc.
Chief Executive Officer, President and Director
Total Annual Compensation: $398.8K
Chief Operating Officer and Executive Vice President
Total Annual Compensation: $285.0K
Chief Scientific Officer and Executive Vice President
Total Annual Compensation: $331.2K
Compensation as of Fiscal Year 2014.
Advaxis, Inc. Key Developments
Advaxis, Inc. Announces Phase 1b Dose-Escalation Clinical Study of ADXS-HER2
Sep 28 15
Advaxis, Inc. 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 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. 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. 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).
Advaxis, Inc. - Special Call
Sep 17 15
To review the Stage 1 clinical data from the GOG-0265 study presented at AGOS 2015
Advaxis, Inc. and Gynecologic Oncology Group Announce Clinical Data from Stage 1 of an Ongoing Two-Stage Phase 2 Study (Gog-0265) of Advaxis's Lm Technology™ Immunotherapy
Sep 17 15
Advaxis, Inc. and Gynecologic Oncology Group announced clinical data from Stage 1 of an ongoing two-stage Phase 2 study (GOG-0265) of Advaxis's Lm Technology™ immunotherapy, axalimogene filolisbac (ADXS-HPV), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) who have progressed on at least one prior line of systemic therapy. The Stage 1 data showed that treatment with axalimogene filolisbac resulted in a 38.5% 12-month overall survival rate in 26 patients. Evaluation of safety data showed that Grade 1 or 2 adverse events occurred in 19 out of 26 patients (73%), with fatigue, chills and fever being the most common. Four patients (15%) experienced a Grade 3 adverse event (hypotension and cytokine release syndrome) and one patient (4%) experienced a Grade 4 adverse event (lung infection and sepsis).
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