OS Therapies announced that its Phase IIb human metastatic osteosarcoma trial produced positive biomarker data, showing that activation of immune blood biomarkers in the interferon‑gamma pathway predicts overall survival and distinguishes long‑term survivors (≥2 years) from short‑term survivors (<1 year).
The biomarker findings are derived from a 118‑patient canine metastatic osteosarcoma study published in February 2025, demonstrating a successful translation of comparative oncology insights into human trials. The pre‑specified pathway analysis confirms that biomarker activation correlates with the 75 % two‑year overall survival rate reported for OST‑HER2.
OS Therapies plans to incorporate the biomarker analysis into its regulatory filings: the United Kingdom by the end of Q2 2026, the United States by the end of Q3 2026, and Europe by year‑end 2026. The data are intended to strengthen the company’s Biologics Licensing Application and Marketing Authorization Application submissions and support its accelerated‑approval strategy.
The biomarker confirmation aligns with OS Therapies’ Rare Pediatric Disease Designation and Fast‑Track status, positioning OST‑HER2 for a potential Priority Review Voucher if accelerated approval is granted before the September 30 2026 deadline.
CEO Paul Romness said, “Leveraging comparative oncology, we trained and tested predictive biomarkers from the canine trial to form a hypothesis tested in a pre‑specified way in the human trial. Confirmation of this pathway analysis in humans adds significant resolution to our clinical data, increasing the interpretability of the 2‑year overall survival data for regulators.”
The positive biomarker data strengthens OS Therapies’ case for accelerated approval and could accelerate market access for a therapy addressing a rare, aggressive cancer with limited treatment options, potentially improving outcomes for metastatic osteosarcoma patients.
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