OS Therapies advances regulatory pathway for bone cancer therapy
Ella Day | August 11, 2025 | News story | Medical Communications, Research and Development | European Medicines Agency’, Medicines and Healthcare products Regulatory Agency, OS Therapies, Oncology, Orthopaedics, US Food and Drug Administration’, bone cancer, osteosarcoma
OS Therapies has announced significant progress in its regulatory strategy for OST-HER2, its lead immunotherapy candidate for preventing or delaying recurrence of fully resected, pulmonary metastatic osteosarcoma. This rare bone cancer mostly affects teenagers and young adults.
Following a successful Scientific Advice Meeting with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the company has submitted an invited Innovative Licensing and Access Pathway application. The MHRA also recommended OS Therapies pursue Project Orbis at the time of regulatory submission, synchronising the review with the US Food and Drug Administration’s (FDA) Accelerated Approval process.
At the same time, the European Medicines Agency’s (EMA) Medicines Evaluation Board has granted OS Therapies a Scientific Advice Meeting in October 2025, marking the start of the EU’s centralised Marketing Authorisation procedure.
OST-HER2 uses a modified Listeria platform to stimulate immune responses against HER2, a protein linked to tumour growth. It has already received multiple regulatory designations, including Rare Pediatric Disease, Fast Track and Orphan Drug status from both the FDA and EMA. OS Therapies’ phase 2b trial of the candidate demonstrated statistically significant improvements in 12-month event-free survival for osteosarcoma patients.
“We are working to ensure FDA and MHRA have everything needed to rapidly approve OST-HER2,” said CEO Paul Romness. “These steps bring us closer to delivering a novel therapy to osteosarcoma patients worldwide.”
OS Therapies plans to submit a Biologics Licensing Application to the FDA in 2025.
Ella Day
11/8/25
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