Jan. 15 at 9:22 PM
OS Therapies. (NYSE American:
$OSTX) announced positive biomarker data from its Phase 2b clinical trial of OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma.
OS Therapies is a B2i Digital Featured Company. View their comprehensive profile at https://b2idigital.com/os-therapies-1.
The results showed that specific immune markers in patients’ blood could distinguish long-term survivors (≥2 years) from short-term survivors (<1 year). According to the company, this adds resolution to the clinical data and increases the interpretability of the 2-year overall survival results for regulatory agencies.
The pathway analysis was pre-specified and based on data from a 118-patient canine osteosarcoma study published in February 2025. When the same pre-specified pathway was confirmed in humans, it validated what the company calls Comparative Oncology: using dog cancer research to inform human drug development.
Regulatory approval targets remain: UK by end of Q2 2026, US by end of Q3 2026, and Europe by year-end 2026. If the company receives Accelerated Approval prior to September 30, 2026, it would become eligible to receive a Priority Review Voucher under the Rare Pediatric Disease Designation program. The most recent PRV sale, in January 2026, was valued at
$200 million.
Paul Romness, MHP, Chairman & CEO noted: “Leveraging the power of Comparative Oncology, we were able to train and test potentially predictive biomarkers from the Canine Metastatic Osteosarcoma Trial in order to form a hypothesis to test in a pre-specified way in the Human Metastatic Osteosarcoma Trial. We believe the confirmation of this pre-specified pathway analysis in humans adds significant resolution to our clinical data, increasing the clinical interpretability of the 2-year overall survival data for regulatory agencies. The confirmation of a pre-specified canine biomarker pathway being upregulated in a comparable human clinical study population leveraged canine biomarker data to a generate hypothesis that was tested in a pre-specified way and confirmed as a surrogate marker of clinical efficacy. This biomarker data strengthens our pending Biologics License Application (BLA) submission.”
See the announcement at: https://ir.ostherapies.com/news-events/press-releases/detail/97/os-therapies-announces-positive-biomarker-data-from-phase
Led by CEO Paul Romness and an executive team that includes Christopher Acevedo (CFO), Robert Petit (Chief Medical and Scientific Officer), Jack Doll (Chief of Staff), and Gerald Commissiong (Chief Business Officer), OS Therapies is focused on advancing immunotherapies for osteosarcoma and other solid tumors.
Learn more at https://www.ostherapies.com and visit B2i Digital for updates. For investor-related questions, please see OS Therapies’ Investor Relations page or email
[email protected].
Disclosure: David Shapiro, CEO of B2i Digital, personally purchased in the open market and currently owns shares of unrestricted OSTX stock. B2i Digital, Inc. is not a broker-dealer or investment adviser. This post is for informational purposes only and is not an offer to sell or a solicitation to buy any security. Investors should conduct their own research and consult with a qualified financial adviser before making any investment decisions. See the complete disclosure in the Risks and Disclosures section of https://b2idigital.com/disclaimer.
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