Advaxis's Cancer Immunotherapy Delays Progression of HER2+ Canine Osteosarcoma

PRINCETON, N.J., June 8, 2015 /PRNewswire/ -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that results from an ongoing clinical study of ADXS-HER2 in canine osteosarcoma (OSA), were presented by principal investigator Nicola J. Mason, B.Vet.Med., Ph.D., DACVIM, Associate Professor of Medicine at the University of Pennsylvania School of Veterinary Medicine, at the 2015 American College of Veterinary Internal Medicine (ACVIM) Forum in Indianapolis, Ind., on June 6, 2015.

The preliminary data presented at ACVIM demonstrate that ADXS-HER2, in combination with palliative radiation, delayed tumor progression and prolonged overall survival in a group of 12 pet dogs with treatment naïve spontaneous OSA. Repeat doses of ADXS-HER2 were well tolerated with no systemic or cardiac toxicity. Of the 12 canine patients recruited to date, seven are alive with current survival times ranging from 66 to 479 days. The median survival time of dogs receiving palliative radiation plus ADXS-HER2 has not been reached. The median time to progression of these 12 canine patients is 238 days. The reported median survival time for historical control dogs with OSA that do not undergo amputation but instead receive the same palliative radiation protocol without ADXS-HER2 is 136 days. Preliminary results from the pilot study were recently presented by Dr. Mason at the 2015 American Association for Cancer Research (AACR) Annual Meeting on April 20, 2015, at which point the study comprised a group of 10 canine patients.

"It is encouraging to see that ADXS-HER2 may have success as a cancer immunotherapy to treat dogs especially as it is associated with very few side effects," said Dr. Mason. "These results add to the growing body of data demonstrating the promising activity of ADXS-HER2."

Data from the first Phase 1 clinical trial in canine OSA were presented last year during the 2014 ACVIM Forum, which showed ADXS-HER2 is able to delay or prevent metastatic disease and significantly prolong overall survival in canines with OSA that had minimal residual disease following standard of care (amputation and follow-up chemotherapy). At the time of the presentation, two-thirds of the treated canine patients were still alive and therefore a median survival time had not been reached. Conversely, historical control dogs that underwent standard of care and did not receive ADXS-HER2 had a median survival time of 316 days.

Advaxis licensed ADXS-HER2 to Aratana Therapeutics (NASDAQ:PETX) in March of 2014 for pet health indications and it is now being developed and prepared for commercialization using the name AT-014. Advaxis and Aratana anticipate conditional licensure of AT-014 for the treatment of canine OSA from the U.S. Department of Agriculture (USDA) in 2016.

Dr. Mason's June 6, 2015 presentation at ACVIM is available on the Advaxis website at www.advaxis.com under the scientific presentations.

Translating Canine Clinical Research into Human Trials

The canine evidence with ADXS-HER2 may have important translational relevance for human patients with OSA and other HER2+ cancers, such as breast, gastric and esophageal. Advaxis expects to initiate a Phase 1b dose-escalation study of ADXS-HER2 in humans with HER2+ solid tumors in mid-2015. Once dosing is established in the human trial, Advaxis plans to work with Children's Oncology Group (COG) to launch a pivotal trial in human pediatric OSA in early 2016. The COG, a National Cancer Institute supported clinical trials group, is the world's largest organization devoted exclusively to childhood and adolescent cancer research.

HER2 is expressed in approximately 40-60 percent of pediatric and canine OSA and in pulmonary metastatic disease, suggesting that immune targeting of HER2 might delay or eliminate metastatic disease. The hypothesis warrants investigation and will be tested in the pivotal pediatric OSA trial. HER2 expression is associated with more aggressive disease, increased risk of relapse and decreased overall survival.

"Advaxis plans to translate this science into human patients, particularly in children with osteosarcoma," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "These data also demonstrate that our Lm Technology™ may offer an opportunity to address HER2+ tumors in pets. We look forward to Aratana building upon these findings to further develop and seek regulatory approval for additional Lm Technology™ antigen-targeted constructs for use in veterinary medicine."

About Canine Osteosarcoma

Osteosarcoma is the most common primary bone tumor in dogs, accounting for roughly 85 percent of tumors on the canine skeleton. More than 10,000 dogs a year (predominately middle to older-aged dogs and larger breeds) are diagnosed with osteosarcoma in the United States. This cancer initially presents as lameness and oftentimes visible swelling on the leg. Current standard of care treatment is amputation, when feasible, immediately after diagnosis, followed by chemotherapy. In cases where amputation is not an option, canine patients may receive radiation for palliative care. Invariably, however, the cancer metastasizes to the lungs, eventually leading to death.

About Advaxis, Inc.

Advaxis 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 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 registration quality 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.  Additionally, Advaxis has entered into another research collaboration with the Incyte Corporation to evaluate ADXS-HPV in combination with its investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360), for the treatment of Stage 1-3b HPV-associated cervical cancer.

Advaxis's Lm Technology™ immunotherapy candidate ADXS-PSA 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 Technology™ cancer immunotherapy, ADXS-PSA, with Merck's PD-1 checkpoint inhibitor KEYTRUDA^(R) (pembrolizumab). The ongoing clinical trial evaluates 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.

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.

SOURCE Advaxis, Inc.

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