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Advaxis Announces First Patient Treated in Phase 1/2 Dose-Escalation Study of ADXS-HPV for Recurrent Cervical Cancer

PRINCETON, N.J., March 19, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced that the first patient was dosed in a Phase 1/2 clinical trial evaluating higher doses and repeat cycles of ADXS-HPV (ADXS11-001), an investigational Lm-LLO immunotherapy, for the treatment of patients with recurrent cervical cancer.

The interventional, open-label, non-randomized dose-escalation study is designed to evaluate the safety, efficacy and immunological effect of ADXS-HPV administered at doses up to 1 x 1010 colony forming units (CFU) in repeat cycles of treatment in approximately 25 women with cervical cancer whose disease recurred after receiving one prior cytotoxic treatment regimen. Preclinical evidence with ADXS-HPV supports the potential for a dose-response relationship and warrants investigation beyond the 1 x 109 CFU 3 dose/cycle administration that has been studied with manageable safety to date. Further information about the Phase 1/2 study can be found on ClinicalTrials.gov, using Identifier NCT02164461.

Sharad Ghamande, M.D., Director of Gynecology Oncology Cancer Center, Georgia Reagents University Cancer Center, and principal investigator for the study, commented, "Recurrent cervical cancer is a fatal disease that has been resistant to most treatments, with a one-year survival rate of approximately 10-15%. Survival data from the Phase 2 studies with a single cycle of ADXS-HPV at a lower dose in this patient population was encouraging, and we hope that we can improve clinical outcomes by using a higher dose and repeat cycles of treatment."

In a completed Phase 2 study in 110 women with recurrent cervical cancer, one cycle (3 doses) of ADXS-HPV, at a dose of 1x109 CFU given as a monotherapy or in combination with chemotherapy, was shown to have a manageable safety profile with a 32% one-year survival rate (n=35/109 randomized treated patients alive at 12 months) and a 16% tumor response rate (n=11/69 response-evaluable patients). Additionally, the Gynecologic Oncology Group (GOG), now part of NRG Oncology, is conducting a single-arm 2-stage study (ClinicalTrials.gov, using Identifier NCT01264460) with ADXS-HPV in patients with recurrent cervical cancer. The first stage of the study met the predetermined safety and efficacy criteria of >/=20% of treated patients surviving 12 months and is now enrolling patients into the second stage of the study.

Daniel J. O'Connor, President and Chief Executive Officer of Advaxis, stated, "Initiation of this Phase 1/2 clinical trial is a significant advancement of our ADXS-HPV development program in that this study is specifically designed to evaluate the potential benefits of treating patients at higher and repeated dosage cycles, which we believe could represent a key differentiator of, and competitive advantage for, ADXS-HPV, as well as our broader Lm-LLO immunotherapy platform among other investigational therapies. Importantly, we are not aware of any other Lm technology that has demonstrated or has the ability to dose safely and effectively at 1 x 1010 CFU. Our hope is that this study will build upon the success of our recently completed and ongoing Phase 2 studies and drive our ADXS-HPV clinical development program forward if higher and repeat dosage regimens of ADXS-HPV offer improved treatment outcomes for these difficult-to-treat cervical cancer patients."

About Cervical Cancer

Cervical cancer is the fourth most common cancer and the most common cause of mortality in women worldwide. Approximately 528,000 new cases are reported annually and an estimated 266,000 deaths from cervical cancer are caused by the human papilloma virus (HPV) worldwide every year according to the World Health Organization / ICO Information Centre on Human Papillomavirus and Related Disease Report 2014. It is estimated that approximately 12,500 women a year are diagnosed with cervical cancer in the United States and approximately 4,000 a year will succumb to the disease. Locally advanced cervical cancer affects approximately 36% of patients at diagnosis (~4,500 in the US alone).

About ADXS-HPV

ADXS-HPV is Advaxis's lead 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 recently completed Phase 2 study of ADXS-HPV demonstrated improved survival and a manageable safety profile alone or in combination with chemotherapy, which warrants further development of the molecule. Clinical trials in head and neck cancer and in anal cancer are ongoing. 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-cHER2, to target the Her2 receptor overexpressing cancers. Her2 is overexpressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, esophageal, and gastric cancer. ADXS-cHER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-cHER2 for both human and animal-health, and has seen promising results in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis is planning to file an IND for ADXS-cHER2 in Her2 overexpressing cancers and to conduct a clinical program in pediatric osteosarcoma. Advaxis has licensed ADXS-cHER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for pet therapeutics.

For more information 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; the safety and efficacy of Advaxis's 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's 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 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