January 29, 2015 1:54 PM ET

Biotechnology

Company Overview of Advaxis, Inc.

Company Overview

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

United States

Founded in 2002

20 Employees

Phone:

609-452-9813

Fax:

609-452-9818

Key Executives for Advaxis, Inc.

Chief Executive Officer
Age: 49
Total Annual Compensation: $398.8K
Chief Operating Officer and Executive Vice President
Age: 45
Total Annual Compensation: $285.0K
Chief Scientific Officer and Executive Vice President
Age: 54
Total Annual Compensation: $331.2K
Compensation as of Fiscal Year 2014.

Advaxis, Inc. Key Developments

Advaxis Announces FDA Acceptance of its Investigational New Drug Application to Commence First-in-Human Clinical Trials of ADXS-HER2

Advaxis, Inc. announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application to conduct a Phase 1 clinical study of ADXS-HER2 (ADXS31-164) for the treatment of patients with metastatic HER2 expressing solid tumors. The clinical trial, which will be the first-in-human study of Advaxis's lead Lm-LLO immunotherapy product for HER2 expressing cancers, is expected to begin patient enrollment in the first half of 2015. In May 2014 [2], Advaxis was granted orphan drug designation by the FDA for ADXS-HER2 in osteosarcoma. The Phase 1 clinical study is designed to evaluate the safety and tolerability of ADXS-HER2 as a monotherapy in patients with metastatic HER2 expressing solid tumors such as breast, gastric, esophageal, and osteosarcoma. Results from the study will be used to determine the future clinical development program of ADXS-HER2. The safety and efficacy of ADXS-HER2 is currently being evaluated in an ongoing Phase 1/2 veterinary clinical study in pet dogs with osteosarcoma, conducted by Nicola Mason, BVet.Med, Ph.D., DACVIM, of the University of Pennsylvania School of Veterinary Medicine. To date, dogs treated (n=15) with ADXS-HER2 immunotherapy, after receiving standard of care (amputation and follow up chemotherapy), had a statistically significant overall survival benefit (p=0.032) compared to dogs (n=13) that only received standard of care. Additionally, the preliminary data suggests immune responses induced by ADXS-HER2 targeted pulmonary micrometastases and prevent the development of metastatic disease in the dog's lungs.

Advaxis, Inc. Presents at Noble Financial Capital Markets Eleventh Annual Investor Conference, Jan-19-2015 03:00 PM

Advaxis, Inc. Presents at Noble Financial Capital Markets Eleventh Annual Investor Conference, Jan-19-2015 03:00 PM. Venue: Club Med, Sandpiper Bay, Florida, United States. Speakers: David J. Mauro, Chief Medical Officer and Executive Vice President.

Advaxis Enters Clinical Trial Collaboration Agreement with GOG Foundation

Advaxis said it's entering a clinical trial collaboration agreement with GOG Foundation, to evaluate the safety and efficacy of the company's lead cancer immunotherapy, ADXS-HPV, in a global Phase 3 cervical cancer trial. ADXS-HPV is an investigational Lm-LLO immunotherapy bioengineered to generate an immune response to the HPV-associated tumor specific oncogene. Prior to commencing this study, Advaxis will discuss the proposed Phase 3 program with the U.S. Food and Drug Administration and will update its investigational new drug (IND) submission. The FDA may request additional information and Advaxis said it will work expeditiously to respond to any such requests. Advaxis also plans to request a Special Protocol Assessment from the FDA.

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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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