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Advaxis's ADXS-cHER2 Immunotherapy Demonstrates T-Cell Immune Response in Data Analysis From Canine Osteosarcoma Study

PRINCETON, N.J., Oct. 30, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that a data analysis of its ongoing Phase 1 clinical study of ADXS-cHER2 in canine osteosarcoma indicates that the immunotherapy breaks peripheral tolerance to HER2/Neu and induces HER2-specific T cell responses in dogs. Additionally, the data suggest that immune responses induced by ADXS-cHER2 target micrometastases and prevent the development of metastatic disease in this spontaneous and clinically relevant model of human osteosarcoma.

This data analysis was performed as an extension of the Phase 1 canine osteosarcoma clinical trial being conducted at the University of Pennsylvania School of Veterinary Medicine. According to the data analysis 50% of the dogs vaccinated with ADXS-cHER2 generated immunological responses against HER2 within four months of treatment. Clear immunological responses were detected against the intracellular component (IC1) of HER2, the highest conserved component between human and canine HER2.

David J. Mauro, M.D., Ph.D., Executive Vice President, Chief Medical Officer of Advaxis, commented, "Though a relatively small sample, this recent data analysis is very compelling and provides evidence that suggests the mechanism of action of ADXS-cHER2 directly contributes to a T-cell specific immune response. This attribute of ADXS-cHER2 has been shown previously in mouse models but now we have direct evidence of the effect in a spontaneous model of human cancer. This finding is also significant as it adds to the potential of Advaxis's ADXS-cHER2 human osteosarcoma program, as well as additional future programs in other HER2 overexpressing cancers such as breast, gastric and esophageal."

Preliminary findings of the Phase 1 clinical trial in dogs with osteosarcoma were presented during the 2014 American College of Veterinary Internal Medicine (ACVIM) Forum by principal investigator, Nicola Mason, B.Vet.Med, PhD. The data suggest that ADXS-cHER2 is safe and well tolerated at doses up to 3 x 109 CFU with no evidence of cardiac, hematological, or other systemic toxicities. The study determined that ADXS-cHER2 is able to delay or prevent metastatic disease and significantly prolong overall survival in dogs with osteosarcoma that had minimal residual disease following standard of care (amputation and follow-up chemotherapy). At this time two-thirds of the treated dogs are still alive and median survival has not been reached. Conversely, dogs undergoing standard of care that did not receive ADXS-cHER2 had a median survival time of 316 days.

Advaxis has granted exclusive worldwide rights to Aratana Therapeutics (Nasdaq:PETX) to develop and commercialize ADXS-cHER2 for the treatment of osteosarcoma in dogs. ADXS-cHER2 has been granted orphan drug status for the treatment of human osteosarcoma by the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD).

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.

CONTACTS:

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