$ADXS for Advancements in Immunotherapy Platform

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Sarcoma Foundation of America Honors Advaxis for Advancements in Immunotherapy Platform

Advaxis, Inc. (ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and theSarcoma Foundation of America, today announced that Advaxis has been awarded the 2016 Vision of Hope Award for their efforts to advance an immunotherapy platform to fight osteosarcoma in patients.

“The Sarcoma Foundation of America is proud to present the Vision of Hope Award to Advaxis Immunotherapies, a trailblazer in the osteosarcoma space,” said Bert Thomas IV, Ph.D., Chief Executive Officer of the Sarcoma Foundation of America. “Their innovative technology gives hope to sarcoma patients in critical need of new treatments and paves the way for additional immunotherapies to offer patients a brighter future.”

Advaxis is the first biotechnology company to ever receive the award for their work in the development of ADXS-HER2, an Lm Technology™ that has received an orphan drug designation from the FDA and EMA for treatment of osteosarcoma. In a study examining canine osteosarcoma, 18 dogs received either 2×108, 5×108, 1×109 or 3.3×109 CFU of ADXS–HER2 post-completion of surgery and adjuvant chemotherapy with 15 dogs showing an induced antigen-specific response within 6 months of immunotherapy administration. Additionally, treatment with ADXS-HER2 reduced the incidence of metastatic disease and prolonged survival relative to a historical control group with only low-grade, transient side-effects.

Osteosarcoma is the most common primary bone tumor in dogs, with more than 10,000 dogs annually diagnosed, and the most common bone cancer in children and teens. It is the third most common cancer in teens after lymphomas and brain tumors. HER2 is expressed in approximately 40 to 60 percent of pediatric and canine osteosarcomas and in pulmonary metastatic disease, providing a strong rationale for HER2 targeted immunotherapy in these cancers.

“We are honored to be chosen as a recipient of this prestigious Award from the Sarcoma Foundation of America,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “We recognize the serious unmet need to treat children and young adults battling this life-threatening disease and are proud to work towards developing immunotherapies that may help change the course of osteosarcoma patients’ lives.”

Advaxis will receive the Vision of Hope Award at the Sarcoma Foundation of America 14th Annual Fundraising Event, “A Celebration of Life,” on Thursday, May 12, 2016 at 6:00 PM EDT in New York City. For further information and to register, visit the Sarcoma Foundation of America’s website.

About Sarcoma

Sarcoma is a rare cancer in adults, accounting for 1 percent of all adult cancers, but rather prevalent in children, accounting for about 15 percent of all childhood cancers. At any one time, 50,000 patients and their families are struggling with sarcoma. Every year, nearly 15,000 new cases are diagnosed and about 6,000 people die from the disease.

About the Sarcoma Foundation of America

The Sarcoma Foundation of America (SFA), a 501(c)(3) nonprofit charitable organization, is an advocate for increased research to find new and better therapies with which to treat patients with sarcoma. The organization raises money to privately fund grants for sarcoma researchers and conducts education and advocacy efforts on behalf of sarcoma patients. For more information, please visit www.curesarcoma.org.

About ADXS-HER2

ADXS-HER2 is an Lm Technology™ immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) 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 to Aratana Therapeutics, Inc. for animal health therapeutics. Aratana expects to receive a conditional USDA license by the end of 2016 to market and sell ADXS-HER2 for dogs with canine osteosarcoma.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary LmTechnology™. The Lm Technology™, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’ lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development.

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