On September 4, 2018 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, and OS Therapies LLC, a clinical-stage therapeutic company focused on the identification, development and commercialization of treatments for osteosarcoma, reported that Advaxis has granted a license to OS Therapies for the use of ADXS31-164, also known as ADXS-HER2, for evaluation in the treatment of osteosarcoma in humans (Press release, Advaxis, SEP 4, 2018, View Source [SID1234529250]).

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Osteosarcoma is an aggressive cancerous tumor that forms in bone. Although it is rare, osteosarcoma is the most common type of bone cancer, and is most frequently found in children and young adults. Current treatment options are limited and there have been no new treatment options in more than thirty years.

Under the terms of the license agreement, OS Therapies, in collaboration with the Children’s Oncology Group (COG)1, will be responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma. Advaxis will receive an upfront payment, reimbursement for product supply and other support, clinical, regulatory, and sales-based milestone payments, and royalties on future product sales. Additional details of the financial terms have not been disclosed.

"Advaxis is pleased to license ADXS-HER2 to OS Therapies for human clinical trials in osteosarcoma. ADXS-HER2, which is already approved in the U.S. for the adjuvant treatment of osteosarcoma in canines, has the potential to provide a new treatment option for human osteosarcoma patients," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "As Advaxis is primarily focused on developing neoantigen-directed therapeutics, this license agreement will allow for the clinical potential of ADXS-HER2 to be explored in osteosarcoma without financial support from Advaxis, building on earlier work performed by us with ADXS-HER2 in a Phase 1 clinical trial."

"The OS Therapies mission is to develop and commercialize new therapeutics for the treatment of osteosarcoma, a deadly and extremely underserved pediatric cancer. We are excited about the opportunity to evaluate ADXS-HER2 in this indication, as its clinical profile has shown promise to date," said Paul Romness, Chief Executive Officer of OS Therapies. "Our initial focus is on the most common genetic mutation found in osteosarcoma, and we believe that HER2, and more specifically ADXS-HER2, holds potential to impact the treatment paradigm."

1 The Children’s Oncology Group (www.childrensoncologygroup.org), a member of the NCI National Clinical Trials Network (NCTN), is the world’s largest organization devoted exclusively to childhood and adolescent cancer research with over 10,000 experts worldwide working in over 200 COG member institutions. COG’s mission is to improve the cure rate and outcome for all children with cancer.