OS Therapies is preparing to share significant clinical trial updates as CEO Paul Romness heads to the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco this January. The presentation comes at a crucial time following the company's 2024 IPO and completion of their Phase 2b clinical trial for OST-HER2 in treating recurrent, resected metastatic osteosarcoma.
Clinical Development Milestone and Regulatory Strategy
The company's lead immunotherapy candidate, OST-HER2, has completed the treatment phase of what could be a pivotal Phase 2b trial. The therapy, which leverages the immune-stimulatory effects of Listeria bacteria to target the HER2 protein, has shown promising results in earlier studies, including a Phase 1 trial primarily focused on breast cancer patients.
"We are excited to begin engaging with the institutional investor community and raise the profile of OS Therapies in the capital markets," stated Paul Romness, Chair and CEO of OS Therapies. "The trial data update planned for the conference week will provide markets with a better understanding of our company's potential for approval in 2025."
Priority Review Voucher Opportunity
A key aspect of OS Therapies' strategy involves the potential receipt of a Priority Review Voucher (PRV), currently valued at approximately $150 million. The company secured rare pediatric disease designation for OST-HER2 in 2021, maintaining eligibility for the voucher despite recent changes in the PRV program reauthorization. The most recent PRV sale, announced on November 27, 2024, saw PTC Therapeutics selling their voucher to Kebilidi for $150 million.
Expansion Plans and Market Potential
Should OST-HER2 receive FDA approval, OS Therapies plans to leverage the PRV sale proceeds to expand clinical development into other HER2-positive cancers, including breast and colorectal cancer. This strategic approach could significantly broaden the therapy's market potential beyond its initial rare pediatric disease indication.
Advanced Technology Platform
Beyond OST-HER2, the company is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC). This innovative platform features the company's proprietary silicone linker technology, enabling multiple payload delivery per linker, potentially enhancing therapeutic efficacy.
The company must secure FDA approval before September 30, 2026, to maintain PRV eligibility, with current projections targeting approval in 2025. This timeline aligns with the company's strategic goals and potential market expansion plans for OST-HER2.
