Posted Date: 2/7/2017

Advaxis’ GOG-0265 Study in Metastatic Cervical Cancer Selected for Late-Breaking Data Presentation

Advaxis, Inc. recently announced that an abstract on data from the company’s Phase II GOG-0265 trial evaluating axalimogene filolisbac for metastatic cervical cancer has been accepted as a late-breaking presentation at the Society of Gynecologic Oncology’s (SGO) 48th Annual Meeting on Women’s Cancer in March.

The poster, A Prospective Phase II Trial of the Listeria-Based HPV Immunotherapy Axalimogene Filolisbac in Second and Third-Line Metastatic Cervical Cancer: A NRG Oncology Group Trial, will be presented by investigator Charles A. Leath, III, MD, Associate Professor of Obstetrics and Gynecology at the University of Alabama at Birmingham School of Medicine. It will highlight final data from the GOG-0265 study, which evaluated the safety and activity of axalimogene filolisbac in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix.

SGO accepts late-breaking abstracts that demonstrate timely findings of the highest scientific impact in the form of an oral presentation followed by a panel discussion at a scientific plenary session during the meeting. The data are selected on the basis of double-blinded peer review and relevance to current gynecologic cancer treatment challenges. Abstracts selected for scientific plenary will also be published in Gynecologic Oncology.

“Axalimogene filolisbac continues to gain validation for its potential as a therapy to treat women with this advanced cervical cancer who have no treatment options other than a repeat of chemotherapy and radiation,” said Daniel J. O’Connor, President and Chief Executive Officer. “We look forward to sharing this data, which supports our plan to initiate a Phase III study in metastatic cervical cancer later this year.”

The SGO’s Annual Meeting on Women’s Cancer, the largest educational and scientific event for members of women’s cancer care teams, which attracts more than 2,000 multi-disciplinary attendees, is March 12-15 at the Gaylord National Resort & Convention Center in National Harbor, MD.

Located in Princeton, NJ, 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, axalimogene filolisbac, targets HPV-associated cancers and is in clinical trials for three potential indications: Phase III in invasive cervical cancer, Phase II in head and neck cancer, and Phase II in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) patients and a SPA for the Phase III AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. 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 and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

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