November 24, 2014 12:39 AM ET

Biotechnology

Company Overview of Advaxis, Inc.

Company Overview

Advaxis, Inc., a clinical development stage biotechnology company, focuses on developing immunotherapies for cancer and infectious diseases. The company’s 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, myeloid-derived suppressor cells, and MDSC to promote immunologic tolerance of cancer cells in the tumor. Its platform technology also facilitates the immune response by altering the tumor microenvironment to reduce immunologic tolerance in the tumors that makes the tumor more susceptible to immune attack. The company has appro...

305 College Road East

Princeton, NJ 08540

United States

Founded in 2002

17 Employees

Phone:

609-452-9813

Fax:

609-452-9818

Key Executives for Advaxis, Inc.

Chief Executive Officer
Age: 49
Total Annual Compensation: $312.5K
Chief Scientific Officer and Executive Vice President
Age: 54
Total Annual Compensation: $371.7K
Compensation as of Fiscal Year 2013.

Advaxis, Inc. Key Developments

Advaxis Submits IND for Phase I/II Trial of ADXS-HPV and MEDI4736 in HPV-Associated Cancers

Advaxis has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for its Lm-LLO immunotherapy ADXS-HPV (ADXS11-001) in combination with MEDI4736 to treat human papillomavirus (HPV) associated cancers. Following approval for the IND application, the company will conduct a Phase I/II trial of ADXS-HPV alone or in combination with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, to treat advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer. Scheduled to start in early 2015, the trial will evaluate the safety and efficacy of ADXS-HPV as monotherapy and in combination with MEDI4736. The Phase I part of the trial is expected to establish a recommended dose regimen of ADXS-HPV with MEDI4736, while the Phase II portion will evaluate the safety and efficacy of the combination.

Advaxis, Inc.'s ADXS-cHER2 Immunotherapy Demonstrates T-Cell Immune Response in Data Analysis from Canine Osteosarcoma Study

Advaxis, Inc. announced that a data analysis of its ongoing Phase 1 clinical study of ADXS-cHER2 in canine osteosarcoma indicates that the immunotherapy breaks peripheral tolerance to HER2/Neu and induces HER2-specific T cell responses in dogs. Additionally, the data suggest that immune responses induced by ADXS-cHER2 target micrometastases and prevent the development of metastatic disease in this spontaneous and clinically relevant model of human osteosarcoma. This data analysis was performed as an extension of the Phase 1 canine osteosarcoma clinical trial being conducted at the University of Pennsylvania School of Veterinary Medicine. According to the data analysis 50% of the dogs vaccinated with ADXS-cHER2 generated immunological responses against HER2 within four months of treatment. Clear immunological responses were detected against the intracellular component (IC1) of HER2, the high conserved component between human and canine HER2. Preliminary findings of the Phase 1 clinical trial in dogs with osteosarcoma were presented during the 2014 American College of Veterinary Internal Medicine (ACVIM) Forum by principal investigator, Nicola Mason, B.Vet.Med, PhD. The data suggest that ADXS-cHER2 is safe and well tolerated at doses up to 3 x 109 CFU with no evidence of cardiac, hematological, or other systemic toxicities. The study determined that ADXS-cHER2 is able to delay or prevent metastatic disease and significantly prolong overall survival in dogs with osteosarcoma that had minimal residual disease following standard of care (amputation and follow-up chemotherapy). At this time two-thirds of the treated dogs are still alive and median survival has not been reached. Conversely, dogs undergoing standard of care that did not receive ADXS-cHER2 had a median survival time of 316 days.

Advaxis, Inc. Appoints David J. Mauro as Executive Vice President and Chief Medical Officer

Advaxis, Inc. announced that it has appointed David J. Mauro, M.D., Ph.D., as Executive Vice President, Chief Medical Officer of Advaxis. Dr. Mauro brings to Advaxis more than 14 years of experience in oncology drug development, clinical research, and medical affairs. In his role as Chief Medical Officer, Dr. Mauro will oversee the company's clinical immuno-oncology programs that utilize bioengineered live attenuated bacteria, Listeria monocytogenes (Lm), to actively suppress key components in the tumor microenvironment that contribute to the tumors growth and protection from immunologic attack. Dr. Mauro most recently served as Executive Director, Section Head Oncology Clinical Development at Merck & Co., Inc. Dr. Mauro will oversee the company's clinical programs, including the planned Phase 3 clinical trial in cervical cancer, the Phase I/II study with ADXS-HPV in combination with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer, and the Phase I/II study with ADXS-PSA in combination with Merck's approved PD-1 inhibitor, Keytruda, in metastatic, castration-resistant prostate cancer.

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Recent Private Companies Transactions

Type
Date
Target
Merger/Acquisition
March 20, 2014
Advaxis, Inc., Worldwide License For Adxs-Cher2 and Three Additional Cancer Immunotherapy Products
 

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