Category: Biotech

Advaxis Presents Preliminary Data From a Phase 1/2 Trial of ADXS-HPV in HPV-Associated Anal Cancer in Combination With Chemoradiation Showing Complete Response and No Recurrences to Date in All Treated Patients

Data Highlighted in Oral Presentation at the International Anal Neoplasia Society Scientific Meeting 2015

PRINCETON, N.J., March 16, 2015 -- Advaxis, Inc. (ADXS), a clinical-stage cancer immunotherapy company, presented preliminary data from the Phase 1/2 clinical study of its lead immunotherapy product candidate, ADXS-HPV (ADXS11-001), in 10 patients with HPV-associated locally advanced anal cancer indicating that all patients who have completed treatment in the study have had a complete response with no evidence of recurrence to date (follow-up ranging from 0.5 -- 24 months). The preliminary data also show that the investigational immunotherapy was well tolerated by the treated patients, and all treatment-related toxicities were within 24 hours of dosing, the most frequent of which include chills/rigors, fever and nausea.

The data were highlighted in an oral presentation by Kimberly Perez, M.D., Assistant Professor of Medicine at the Alpert Medical School, Brown University, during the recent International Anal Neoplasia Society (IANS) Scientific Meeting 2015, in Atlanta, Georgia.

Dr. Perez stated, "Though preliminary, the data we have observed thus far are extremely encouraging as all treated patients enrolled since April 2013 have had a complete response with no recurrence of the cancer. ADXS-HPV has the potential to be an important advancement in the treatment of HPV-associated anal cancer, and we look forward to reporting the full safety and efficacy data set once all 25 patients have completed the dosing regimen."

BrUOG 276 ( Identifier: NCT01671488) is a Phase 1/2 non-randomized, open-label, multi-center study being conducted by the Brown University Oncology Group with financial support from The Farrah Fawcett Foundation. The study is designed to determine the safety and effectiveness of ADXS-HPV when combined with standard chemotherapy and radiation treatment for locally advanced anal cancer in approximately 25 patients who have a high risk of recurrence based on their disease characteristics. The primary efficacy objective of the study is to assess the proportion of patients maintaining a clinical complete response at the 6-month mark.

David J. Mauro, M.D., Ph.D., Chief Medical Officer of Advaxis stated, "We are very pleased with the preliminary data from this Phase 1/2 study of ADXS-HPV in HPV-associated anal cancer as it adds to the encouraging data that we have observed in our additional ADXS-HPV programs and across our broader Lm-LLO cancer immunotherapy portfolio. We look forward to reviewing the full data set from this trial in support of the continued clinical development of ADXS-HPV in HPV-associated anal cancer."

About HPV and Anal Cancer

According to the American Cancer Society, most squamous cell anal cancers seem to be linked to infection by the human papilloma virus (HPV), the same virus that causes cervical cancer. In fact, women with a history of cervical cancer (or pre-cancer) have an increased risk of anal cancer. Anal cancer is fairly rare -- much less common than cancer of the colon or rectum. About 7,210 new cases will be diagnosed and about 950 people are expected to die of anal cancer in the United States during 2014.

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(R) (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.

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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 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.

Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
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609.452.9813 ext. 102
Media Contact:
Tiberend Strategic Advisors, Inc.
Amy S. Wheeler
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