Advaxis Unveils State-of-the-art Manufacturing Facility, Laboratory to Produce and Develop Novel Immuno-Oncology Therapeutics

NJ Gov. Christie cuts ribbon, commends Advaxis milestone

Advaxis Unveils State-of-the-art Manufacturing Facility, Laboratory to Produce and Develop Novel Immuno-Oncology Therapeutics

PRINCETON, N.J., Sept. 12, 2016 -- Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, welcomed New Jersey Governor Christopher J. Christie and BioNJ President and Chief Executive Officer Debbie Hart on Sept. 9 to celebrate the completion of its new state-of-the-art manufacturing facility and laboratory with a ribbon-cutting event before close to 200 people.

A photo accompanying this release is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/756b5c86-d837-4a11-93cc-513b45f126bb.

Advaxis built out the 30,000-square-foot expansion at its College Road East headquarters to include a clean-room manufacturing and laboratory facility to develop and manufacture clinical-grade products to support Advaxis’ clinical trials and future commercialization of its immuno-oncology therapeutics.

“I’m proud Advaxis is increasing its footprint and investment in the Garden State and specifically the Princeton Corridor, which in the past several years has grown as a beacon for world-renowned biotech and life sciences accomplishments,” Governor Christie said. “For the benefit of New Jerseyans, Advaxis is emerging as a leading innovator in the biotech industry, rapidly developing state-of-the-art cancer treatment for patients in need, creating great private-sector jobs and attracting private investments from global companies who want to be a part of its budding successes.”

Advaxis is conducting several clinical trials evaluating its proprietary Lm Technology™ using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria to activate the immune system to attack cancer cells. In addition, the company announced a global collaboration agreement with Amgen for its My Immunotherapy Neo-Epitopes or MINE™ program for the development of ADXS-NEO, which will enter phase 1 trials in 2017.

“The Advaxis team believed in this technology and believed that it could help patients in need even when the company was struggling a few years ago, but just this year, the company has reported two complete responses in patients who have received AXAL in clinical trials, meaning the cancer in these two patients has disappeared,” said Ms. Hart during the event. “Advaxis is a true New Jersey success story.”

AXAL, or axalimogene filolisbac, is being tested in a Phase 3 clinical study called AIM2CERV to evaluate safety and efficacy in patients with high-risk, locally advanced cervical cancer. The U.S. Food and Drug Administration (FDA) has granted AXAL orphan drug designation as well as Fast Track designation for adjuvant therapy and a Special Protocol Assessment for the Phase 3 AIM2CERV trial. The trial is set to dose its first patient this year.

“Governor Christie’s administration has worked to help life science companies like Advaxis and many others succeed here in New Jersey, and his leadership in this field has benefited our state with jobs and economic development, and, more importantly, has facilitated Advaxis’ opportunity to develop its immunotherapies with the goal of helping cancer patients around the world for years to come,” said Daniel J. O’Connor, president and CEO of Advaxis. 

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, AXAL, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted AXAL orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. AXAL has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the European Medicines Agency's Committee for Advanced Therapies. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development.  In addition, Advaxis and Amgen are developing ADXS-NEO, a preclinical investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

For additional information on Advaxis, visit http://www.advaxis.com/ and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to: statements regarding the completion and timing of the offering of shares. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’ SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2015, which is available at http://www.sec.gov, as well as the risks identified or incorporated by reference in the registration statement and the prospectus supplement relating to the offering. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Company:

Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
[email protected]
609.250.7515

Media Contact:

JPA Health Communications
David Connolly
[email protected]
617.945.9316