OS therapies’ regulatory update in drug development submission procedure

Image Credit: Drug Discovery and Development

Announcement

OS Therapies Inc., a leading antibody drug conjugate and clinical-stage cancer immunotherapy biotechnology company has informed a regulatory update on its further plans for completing its marketing authorizations in the united kingdom (UK) and united states (US) for OST-HER2 in the late or prevention of fully resected, pulmonary metastatic osteosarcoma related on a data created form its qualified phase 2b clinical trial, recently in long run follow up phase. The company upgraded its regulatory filing sequence to first prioritize the Healthcare Products Regulatory Agency (MHRA) and UK medicines. Along with the conditional marketing authorization application (MAA), the finalized module submission is in the accelerated approval program (accelerated approval).

The company is trying to complete the MHRA conditional MAA submission by December 2025, along with the FDA BLA accelerated approval submission to be initiated in January 2025. OS therapies has already submitted a conditional MAA pre-submission request due to MHRA feedback arising from the scientific advice meeting (SAM) held in August 2025. The company hopes to receive formal approval of its commercialized review request to MHRA soon.

The MHRA has linked across the usage of peer-reviewed historical control data as a comparator strength to support the company’s conditional MAA request. The MHRA has been convinced to contribute to OS therapies initiatives to gain case-suitable external control arm data by enabling access to the UK-based clinical practice research datalink (CPRD).

Explanation

The information given in the MHRA conditional MAA submission is closely connected with the details in the well-planned US FDA BLA accelerated approval request. Apart from this connection in the approvable comparator arm against which to vary the efficacy data from the OS therapies’ phase 2b trial of OST-HER2. After phase 2 and the follow-up talk ended with the FDA, the general connectors were clear on all matters except for matched comparators. Listening to the FDA, the company has called for a type C meeting to check the new biomarker and updated overall survival data.

The company plans to signal if the immune activation biomarker data can be considered as a surrogate marker aligned with 2-year interim overall survival as a secondary approach. Following, which will be relatable to a surrogate marker of efficacy to boost accelerated approval.

The MHP, Chairman and CEO of OS Therapies, Paul Romness, said, “We’ve met the deep understanding of what the FDA wants for us to contribute an efficacy claim as a result of our conversation over the last 45 days.”