Advaxis Company

AdvaxisAdvaxis, Inc.
Noelle Heber
Sr. Director, Corporate Communications and Government Affairs
305 College Rd East
Princeton, NJ 08540, USA

Advaxis is a clinical-stage biotechnology company focused on developing cancer immunotherapies that use the body’s natural immune system to redirect the immune response to kill cancer. For decades, cancer researchers have been trying to stimulate the body’s immune system to identify and kill cancer cells, with the goal of creating a standard “immunologic” treatment against tumors that is more effective and more tolerable than traditional chemotherapy or radiation. Our clinical programs are evaluating the ability of Advaxis cancer immunotherapies to improve survival and reduce the frequency and severity of side-effects commonly associated with standard chemotherapy and radiation.

Advaxis’s technology was discovered at the University of Pennsylvania and is based on live attenuated, bioengineered gram-positive bacteria that stimulate the patient’s own immune system to selectively target cancer cells for elimination, while simultaneously reducing tumor defenses in the microenvironment. Capitalizing on the body’s ability to still recognize and attack a “perceived” bacterial infection, Advaxis’s technology – like a Trojan Horse – delivers an army of genetically engineered bacteria to “trick” the patient’s immune system into thinking that the cancer cells are bacterially infected cells and should therefore be eliminated. Advaxis is developing the only cancer immunotherapies shown to actively suppress the key components in the tumor microenvironment (Treg’s and MSDCs) that protect the tumor from immunologic attack and contribute to tumor progression.

Advaxis is actively seeking commercialization partners for the license and development of its proprietary investigational Lm TechnologyTM immunotherapies.
Advaxis has created more than 20 distinct immunotherapy candidates based on its proprietary platform that are available for partnering in anti-PD-1 combination therapy, recurrent cervical cancer, HPV-associated head and neck cancer, HPV-associated anal cancer, prostate cancer, HER2 overexpressing cancer, and others

Advaxis is a clinical-stage biotechnology company focused on the development of immunotherapies to treat multiple different types of cancers. We are currently conducting clinical trials with our lead product candidate, axalimogene filolisbac (ADXS-HPV), in HPV-associated cervical cancer (late-stage trials), head and neck cancer (Phase 1/2) and anal cancer (Phase 1). Our second lead product candidate is ADXS-HER2, which we intend to develop for pediatric osteosarcoma and other HER2 overexpressing cancers, such as breast cancer. We intend to develop our third product candidate, ADXS-PSA, for prostate cancer, as well as to explore the potential to combine any of our proprietary immunotherapies in combination with other anticancer therapies. Advaxis has three commercial partnerships with other major biopharmaceutical companies for the development and commercialization of our proprietary cancer immunotherapies in countries outside the U.S. and for the global animal-health oncology market. Advaxis has created and is developing more than 20 distinct immunotherapies based on its proprietary Lm TechnologyTM, either directly or through strategic collaborations with recognized cancer centers of excellence.

Business Description:
Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™ that is being investigated for redirecting the immune system to kill cancer.

Clinical Pipeline:
ADXS-PSA Clinical Program for Prostate Cancer
ADXS-PSA is currently in development for the treatment of prostate cancer and has been evaluated preclinically both as a single agent and in combination with other immunotherapies. In December 2014 the FDA cleared Advaxis’ Investigational New Drug (IND) application to conduct a phase I-II clinical study to evaluate the combination of ADXS-PSA (ADXS31-142) with Keytruda® (pembrolizumab), marketed by Merck & Co., Inc., in patients with previously treated, metastatic castration-resistant prostate cancer. The phase I part of the trial, which will be the first-in-human study of Advaxis’ lead Lm Technology™ product candidate in prostate cancer, is expected to begin patient enrollment in the first quarter of 2015 and will be a dose-escalating study designed to establish the maximum tolerated dose of ADXS-PSA when used alone and in combination with Keytruda. The phase II portion will assess the safety and efficacy of the combination immunotherapy regimen.

ADXS-HER2 Clinical Program for HER2-Expressing Solid Tumors:
ADXS-HER2 is currently in development for the treatment of human epidermal growth factor receptor 2 (HER2)-overexpressing human cancers, including breast, gastric, and esophageal solid tumors and osteosarcoma. In May 2014, ADXS-HER2 was granted Orphan Drug Designation by the FDA for osteosarcoma. In January 2015, the FDA cleared Advaxis’ IND application to conduct a phase I 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’ lead Lm Technology™ product for HER2-expressing cancers, is expected to begin patient enrollment in the summer of 2015 and will 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.

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