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Advaxis and RTOG Foundation to Collaborate on Pivotal Phase 2/3 Clinical Trial of ADXS-HPV in Anal Cancer

PRINCETON, N.J., April 6, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that it is entering into a clinical trial collaboration agreement with the Radiation Therapy Oncology Group (RTOG) Foundation to evaluate the safety and efficacy of Advaxis's lead cancer immunotherapy, ADXS-HPV (ADXS11-001), in a pivotal Phase 2/3 anal cancer trial, which will be run by NRG Oncology. ADXS-HPV is an investigational Lm-LLO immunotherapy bioengineered to generate an immune response to the HPV-associated tumor specific oncogene.

Under the proposed collaboration, RTOG Foundation, through its partnership with NRG Oncology, will conduct an adequate and well-controlled Phase 2/3 clinical trial of concurrent chemotherapy of mitomycin C/5FU and radiation therapy (CCRT) compared to CCRT combined with ADXS-HPV in the adjuvant treatment of high-risk locally advanced anal cancer.

Walter J. Curran, Jr., MD, RTOG Foundation Chairman of the Board and NRG Oncology Group Chair, commented, "The ability of ADXS-HPV to generate an immune response to the HPV-associated tumor specific oncogene offers the potential to benefit multiple cancers that are known to be caused by the HPV infection, including cervical cancer and anal cancer. We look forward to initiating this Phase 2/3 study in anal cancer and mirroring the encouraging results that the Gynecologic Oncology Group, now a part of NRG Oncology, has had in its clinical study of ADXS-HPV in cervical cancer."

David J. Mauro, MD, PhD, Executive Vice President and Chief Medical Officer of Advaxis, stated, "We are excited to enter this collaboration agreement with NRG Oncology and look forward to building on the initial results observed in the ongoing Phase 1/2 study of ADXS-HPV in anal cancer being conducted by Professor Howard Safran MD of Brown University Oncology Group. Although a relatively rare tumor, virtually all cases of squamous cell cancer of the anus are caused by HPV infection, and ADXS-HPV offers the potential to treat this often fatal malignancy."

About RTOG Foundation, Inc.

The Radiation Therapy Oncology Group (RTOG) has been an international leader in conducting Phase 2 and 3 multi-institutional clinical trials with a focus on radiation oncology issues. During its forty-plus year history, the group has repeatedly defined new standards of cancer care to improve the survival and quality of life of cancer patients and developed new processes for the study and application of innovative radiotherapy technologies. RTOG Foundation, Inc. is a Philadelphia based 501(c)(3) organization that continues its National Cancer Institute (NCI) funded research activities through NRG Oncology as one of its three founding members. RTOG also joins with corporate partners to conduct multicenter clinical trials systematically testing novel radiotherapy approaches combined with new classes of anti-cancer therapies and targeted agents. The group has completed a number of practice- and paradigm-changing trials in its primary disease sites: central nervous system, head & neck, lung, gastrointestinal (esophagus, stomach, pancreas, anal canal, and rectum), genitourinary (bladder and prostate), breast, and cervix.

About NRG Oncology

NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of patients with cancer. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit corporation that integrates the research strengths of the National Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG) and the Gynecologic Oncology Group (GOG). The research organization seeks to carry out clinical trials with emphases on gender-specific malignancies including gynecologic, breast, and prostate cancers and on localized or locally advanced cancers of all types. NRG Oncology's extensive research organization is comprised of multidisciplinary investigators including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians and encompasses more than 1300 research sites located world-wide with predominance in the United States and Canada. NRG Oncology is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI's National Clinical Trials Network.

About ADXS-HPV

ADXS-HPV is Advaxis's lead Lm-LLO immunotherapy product candidate for the treatment of HPV-associated cancers. It is currently under investigation in three HPV-associated cancers: invasive cervical cancer, head and neck cancer, and anal cancer. In cervical cancer, a completed Phase 2 study, ADXS-HPV demonstrated prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of this Lm-LLO immunotherapy. The U.S. Food and Drug Administration granted an orphan drug designation for ADXS-HPV for HPV-associated Stage II-IV cervical cancer, head and neck cancer, and for anal cancer.

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm-LLO platform technology. The Lm-LLO technology, using bioengineered live attenuated Listeria monocytogenes bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm-LLO immunotherapy, ADXS-HPV, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The FDA has granted Advaxis orphan drug designation for each of these three indications. The Company plans to initiate a registrational clinical program for cervical cancer in 2015 and has established licensing partners in India and Asia for commercialization in those regions. Advaxis entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, for a Phase 1/2 immunotherapy study to evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis's ADXS-HPV as a treatment for patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.

Advaxis's second Lm-LLO immunotherapy candidate in clinical testing will be ADXS-PSA, which is being developed to address prostate cancer. Advaxis entered into a clinical trial collaboration agreement with Merck & Co., Inc. ("Merck"), known as MSD outside the United States and Canada, through its subsidiaries, to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab). The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer.

Advaxis is also developing Lm-LLO immunotherapy ADXS-HER2, to target the HER2 receptor expressing cancers. HER2 is expressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, esophageal, and gastric cancer. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal-health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for pet therapeutics.

For more information about our cancer immunotherapies please visit www.advaxis.com.

Forward-Looking Statements

This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis's proprietary immunotherapy, ADXS-HPV. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis's SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. 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.

KEYTRUDA is a registered trademark of Merck & Co., Inc.

CONTACT: Company: Advaxis, Inc. Greg Mayes, Executive Vice President and COO mayes@advaxis.com 609.452.9813 ext. 102 Media Contact: Tiberend Strategic Advisors, Inc. Amy S. Wheeler awheeler@tiberend.com 646.362.5750

Source:Advaxis