OS Therapies Announces Formation of Osteosarcoma Patient Advocacy Advisory Board
OS Therapies, a biopharmaceutical company specializing in cancer immunotherapy and Antibody Drug Conjugates (ADCs), has announced the establishment of a Patient Advocacy Advisory Board (PAAB) for its osteosarcoma program. The PAAB’s role is to represent the osteosarcoma community’s perspectives on the need for new therapies as the company prepares for discussions with the US Food & Drug Administration (FDA), particularly concerning a potential Biologics License Application (BLA) for its immunotherapeutic product candidate, OST-HER2.
The PAAB members are:
- Miriam Cohen – Chair of Osteosarcoma Collaborative
- Mac Tichenor – Chair of Osteosarcoma Institute
- Tony Trent – Chair of Tyler Trent Foundation
- Olivia Egge – Osteosarcoma Patient, OSTX Board
- Serena Subada – Osteosarcoma Patient, AOST-2121 OST-HER2 Trial Participant
The PAAB members will serve voluntarily without financial compensation from OS Therapies. They are expected to meet quarterly to review updates on the company’s osteosarcoma clinical program, with meetings chaired by the company’s CEO.
OST-HER2, OS Therapies’ leading product candidate, is an innovative immunotherapy that utilizes a HER2-engineered form of the bacterium Listeria monocytogenes to elicit a potent immune response against HER2-expressing cancer cells. This off-the-shelf treatment aims to prevent metastasis, delay recurrence, target primary HER2-expressing tumors, and enhance overall survival. The company has fully enrolled a potentially pivotal Phase IIb clinical trial, administering OST-HER2 to 41 patients across 21 US clinical trial sites. Interim results reported in June 2024 were positive, with topline data anticipated in the fourth quarter of 2024.
OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the FDA, and both Fast Track and Orphan Drug Designations from the FDA and European Medicines Agency (EMA). OS Therapies is pursuing Breakthrough Therapy Designation for OST-HER2 based on Phase IIb trial data. If granted, the FDA will provide a Priority Review Voucher for OST-HER2’s BLA submission. In 2023, the FDA approved 28 drugs and 12 biologics for orphan diseases. OST-HER2 has also completed a Phase I clinical trial primarily in breast cancer patients, demonstrating strong preclinical efficacy both as a standalone treatment and in combination with HER2-targeting therapies like Herceptin®. The company plans to further develop OST-HER2 for breast cancer following potential FDA approval for osteosarcoma.
This press release does not constitute an offer or solicitation to buy any securities, nor will there be any sale of securities in jurisdictions where such offers or sales would be unlawful prior to registration or qualification under relevant securities laws.
About Osteosarcoma
Osteosarcoma is a malignant bone tumor that primarily affects children and young adults. It is a challenging and aggressive cancer with treatment difficulties due to its location, varying genotypes, and high recurrence rates. Standard treatment typically includes surgery and chemotherapy. Patients with metastatic or recurrent disease after chemotherapy face a notably poorer prognosis.
About OS Therapies
OS Therapies is a clinical-stage oncology company dedicated to identifying, developing, and commercializing treatments for osteosarcoma and other solid tumors. The company’s lead asset, OST-HER2, is an immunotherapy that harnesses the immune-stimulatory properties of Listeria bacteria to target the HER2 protein. OS Therapies has completed enrollment in a 41-patient Phase IIb trial of OST-HER2 for resected recurrent osteosarcoma, with results expected in the fourth quarter of 2024. The company has also advanced a next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which features customizable antibody-linker-payload candidates utilizing proprietary silicone linker technology.
