On January 27, 2022 OS Therapies, a research and clinical-stage biopharmaceutical company reported that the Data Safety & Monitoring Committee (DSMC) approved open enrollment for AOST-2121: an open label Phase IIb Trial of OST-HER2 (Listeria monocytogenes) in Recurred, Resected Osteosarcoma (OS) (Press release, OS Therapies, JAN 27, 2022, View Source [SID1234607463]). OS is a deadly and debilitating cancer of the bone that usually occurs in adolescence and young adults (AYA).

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OS Therapies’ OST-HER2 is a Lm vector-based off-the-shelf Immunotherapy intended to prevent metastasis, delay recurrence, and increase overall survival. The FDA had requested a safety roll-out staggering the first three patients by three weeks – safety data from these patients has given the safety committee the ability to open the trial nationally to the remaining patients.

"The Osteosarcoma Community has been anxiously awaiting the clinical trial of this very promising technology ever since it was provisionally approved for dogs by the USDA – we just want to try it on our kids," said Miriam Cohen, Chair of the Osteosarcoma Collaborative (www.oscollaborative.org), an OS patient advocacy organization that has supported the trial.

Eleven of the twenty clinical trial sites currently open include:
Seattle Children’s Hospital
Connecticut Children’s Hospital
UPMC Children’s Hospital of Pittsburgh
Kaiser Permanente Downey Medical Center
St. Jude’s Children’s Research Hospital
Johns Hopkins Baltimore
UT Southwestern Children’s Medical Center
Hackensack University Medical Center
Children’s Hospital of Orange County
Rady Children’s Hospital
Children’s Hospital of Philadelphia (CHoP)

About Osteosarcoma
Osteosarcoma is a solid tumor of the bone that predominantly occurs in adolescent and young adults (AYA). Standard treatment includes surgery and chemotherapy. For patients with initially metastatic or recurrence after chemotherapy, there is a significantly poorer prognosis.