On March 11, 2025 OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, reported that it has scheduled a Scientific Advice Meeting (SAM) in the third quarter of 2025 to discuss the Innovative Licensing and Access Pathway (ILAP) with the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) for OST-HER2, its immunotherapy candidate for the prevention of recurrence of metastases in osteosarcoma (Press release, OS Therapies, MAR 11, 2025, View Source [SID1234651086]). The Company released positive Phase 2b data in January 2025 that demonstrates statistically significant results in the primary endpoint of the study, 12-month event free survival (EFS). The meeting with MHRA has been scheduled to position the Company to bring OST-HER2 to market in the UK in 2025.
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"Today’s announcement marks the beginning of the regulatory process required to bring our OST-HER2 immunotherapy to market globally," stated OS Therapies’ CEO Paul Romness. "As we prepare for regulatory interactions in the UK, US, Europe and other regulatory bodies worldwide, we are now focused on aligning our regulatory strategy to getting our product to patients as quickly as possible."
The UK is a reference country for multiple national drug approval agencies worldwide, meaning that if the Company receives approval in the UK then it becomes eligible to receive approval in other certain countries including Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Spain, and Sweden. OST-HER2 has received Fast Track and Orphan Drug designations from the European Medicines Agency.