Advaxis Expands Collaboration With GRU Cancer Center at Georgia Regents University to Conduct Four Cancer Immunotherapy Clinical Trials

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PRINCETON, N.J., Feb. 5, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a biotechnology company developing the next generation of cancer immunotherapies, announced it has expanded its relationship by entering into a master clinical trial agreement with GRU Cancer Center to conduct four Phase 1/2 clinical trials. The trials will be conducted under the supervision of Dr. Samir Khleif, Director, GRU Cancer Center and former Chief of the Vaccines Section at the National Cancer Institute (NCI).

The planned trials will further develop Advaxis' two lead immunotherapies: ADXS-HPV for cervical cancer and ADXS-cHER2 for breast cancer. The four clinical trials will be designed to assess:

  • High dose, repeating cycles of ADXS-HPV in recurrent or refractory cervical cancer.
  • ADXS-cHER2 in women with Her2/neu over-expressing breast cancer with measurable disease who have progressed after prior standard therapy.
  • The optimal combination dose of ADXS-HPV and PD-1 antibody in patients with recurrent or refractory cervical cancer.
  • ADXS-HPV prior to surgery in patients with surgically treatable cervical cancer.

Dr. Samir N. Khleif, principle investigator, commented, "The preclinical success we have had with the Advaxis platform technology has prompted us to move into human trials with multiple treatment approaches for cervical and breast cancer. We hope to see positive results in cervical and breast cancer patients as we partner with Advaxis in developing its novel treatments."

"We are excited that Dr. Khleif, a visionary in oncology, and his elite team at the most prominent center for cancer immunology research will conduct these additional trials with two of our immunotherapies," commented Daniel J. O'Connor, Chief Executive Officer of Advaxis. "Through our prior collaboration, Dr. Khleif has already generated positive preclinical data using ADXS-HPV in combination with anti-PD-1 therapy."

About Dr. Samir N. Khleif

Dr. Khleif is Director of the GRU Cancer Center and former Chief of the National Cancer Institute's (NCI) Cancer Vaccine Section, medical oncology consultant with the National Naval Medical Center, and Professor of Medicine at the Uniformed Services University of the Health Sciences. His research group designed some of the first cancer vaccine clinical trials targeting specific genetic changes in cancer cells, studying ways to enlist the immune system's cooperation with cancer treatment, both by bolstering its ability to attack cancer cells and inhibiting its faulty interference with cancer treatment. During his tenure at the NCI, Dr. Khleif served as the Director General and Chief Executive Officer of the King Hussein Cancer Center and then of the King Hussein Institute for Biotechnology and Cancer, appointed by the Secretary of the Department of Health and Human Services through an agreement between the United States Government and the Kingdom of Jordan. He has also served as a Special Assistant to the FDA Commissioner, leading oncology efforts to make drug discovery and development more efficient, innovative, and cost effective.

About GRU Cancer Center

The GRU Cancer Center in Augusta, Ga., provides cancer care as a cooperative organization for Georgia Regents University. The Cancer Center's patients-first model is built on a foundation of teamwork and synergy between the research and clinical facilities. The GRU Cancer Center, which is working toward NCI designation, includes a 167,000-square-foot research building, opened in 2006, and a clinical facility that opened in 2010. Together, they provide state-of-the-art research and treatment, including several first-in-human protocols. The major investments the university and its health system have made in cancer in recent years make it fertile ground to produce the next big advancement in cancer research and clinical care.

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing the next generation of cancer immunotherapies. Advaxis' immunotherapies are based on a novel platform technology using live, attenuated bacteria to stimulate the immune system to selectively target cancer cells while reducing tumor defenses.

ADXS-HPV, Advaxis' lead immunotherapy for the treatment of HPV-associated cancers, has improved survival and objective tumor responses in a Phase 2 trial in 110 patients with recurrent cervical cancer. Advaxis is now planning the registrational program for ADXS-HPV. ADXS-HPV is also being evaluated in other HPV-associated cancers including a Phase 2 in advanced cervical cancer, a Phase 1/2 in head & neck cancer, and a Phase 1/2 in anal cancer. ADXS-HPV has orphan drug status for both anal and head and neck cancers. As part of its global commercialization strategy to enter into regional licensing deals with other market dominant biopharmaceutical companies in territories where there is a high prevalence of HPV-associated cancers, Advaxis has granted exclusive licenses for the development and commercialization of ADXS-HPV in Asia and India.

ADXS-cHER2 is an immunotherapy for the treatment of HER2 overexpressing cancers (such as breast, gastric, esophageal, and other cancers in humans and for osteosarcoma in canines). Advaxis' lead animal-health immunotherapy, ADXS-cHER2, has demonstrated encouraging survival data in a Phase 1 trial in canine osteosarcoma. These data provide the rationale to advance this same immunotherapy into a Phase 1 clinical trial in women with HER2-positive breast cancer. The Company is preparing an IND submission for ADXS-cHER2 in breast cancer in 2014.

Advaxis has created more than 15 distinct immunotherapies based on its platform either directly or through strategic collaborations with recognized cancer centers of excellence such as: the University of Pennsylvania, Brown University, the Georgia Regents University Cancer Center, the Icahn School of Medicine at Mount Sinai, and others.

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Forward-Looking Statements

This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis' ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis' proprietary immunotherapy, ADXS-HPV; whether Advaxis immunotherapies can redirect the powerful immune response all human beings have to the bacterium to cancers. 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, 2013, which is available at 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.

CONTACT: Advaxis Contact: Lisa Caperelli Senior Director of Investor Relations and Corporate Communications Advaxis, Inc. 215.206.1822 Media Contact: Andrew Mielach Tiberend Strategic Advisors, Inc. 212.375.2694