On January 19, 2021 Advaxis, Inc. (NASDAQ: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that the Company has received the first milestone payment related to its licensing agreement for ADXS31-164, now known as OST-HER2, to OS Therapies for evaluation in the treatment of osteosarcoma in humans (Press release, Advaxis, JAN 19, 2021, View Source [SID1234574096]).
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Under the terms of the amended and restated license agreement, OS Therapies, in collaboration with the Children’s Oncology Group (COG)1, is responsible for the conduct and funding of a clinical study evaluating OST-HER2 in recurrent, completely resected osteosarcoma. OS Therapies secured funding to support this research, triggering the first milestone payment. Under the agreement, Advaxis will receive additional clinical, regulatory, and sales-based milestone payments as well as royalties on future product sales. Additional details of the financial terms have not been disclosed.
"We are pleased that OS Therapies is now in position to initiate human clinical trials of OST-HER2 in osteosarcoma," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "ADXS31-164, which had been conditionally 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, particularly in children with this challenging disease for which there are few therapeutic options. As Advaxis is currently focused on developing our ADXS-HOT neoantigen-directed off-the-shelf therapeutics, with recent encouraging data in non-small cell lung cancer, we hope that OS Therapies can successfully explore the clinical potential of OST-HER2 in osteosarcoma, building on an earlier Phase 1 clinical trial performed by us where ADXS31-164 was safe and tolerable in humans."
Paul Romness, Chief Executive Officer of OS Therapies, said, "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 to be in position to evaluate OST-HER2 in this indication, as it has been safe and effective in treating osteosarcoma in dogs, a natural model that is the similar to humans, and to be safe and tolerable in humans. Our goal is to stimulate the immune system to specifically target tumor dysplastic cells that express HER2, which is a common genetic mutation found in osteosarcoma. We believe that targeting Osteosarcoma and other solid tumors with OST-HER2 holds potential to impact the treatment paradigm."
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.
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.