On March 31, 2025 OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported a regulatory update for its OST-HER2 listeria monocytogenes (Lm) immunotherapeutic cancer biologic drug candidate in the prevention or delay of fully-resected, recurrent, lung metastatic osteosarcoma (Press release, OS Therapies, MAR 31, 2025, View Source [SID1234651701]).
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"We are making rapid progress in putting together an appropriate data package to achieve accelerated approval for OST-HER2 given the feedback we’ve received to date from the FDA," said Paul Romness, MHP, Chairman & CEO of OS Therapies. "We know one of the US government’s stated priorities is to treat deadly childhood cancers, and we believe that OST-HER2 for osteosarcoma aligns well with that mission."
Regulatory Timelines
The Company initiated regulatory correspondence with the US Food & Drug Administration (FDA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in the first quarter of 2025. The Company intends to initiate regulatory interaction with the European Medicines Agency (EMA) and EMA National Competent Authorities in the second quarter of 2025.
FDA
Q1/25: Regulatory communication regarding endpoints for accelerated approval
Q2/25: End of Phase 2 Meeting
Q3/25: Initiation of rolling BLA submission
Q4/25: Conditional BLA via Accelerated Approval Program
MHRA
Q1/25: Scientific Advice Meeting requested and granted
Q3/25: Scientific Advice Meeting with MHRA and ILAP application submission
Q4/25: Application for joint Scientific Advice Meeting with MHRA and National Institute for Health and Care Excellence (NICE)
Q4 25: MHRA Conditional Marketing Authorisation application.
EMA
Q2/25: EMA National Competent Authority Scientific Advice Meeting Request (Medicines Evaluation Board, Netherlands)
Q3/25: EMA PRIME and EMA Orphan Designation applications
Q4/25: EMA-FDA Parallel Scientific Advice application
Q1 26: EMA Conditional Marketing Authorisation application.
The Company has recently buttressed its regulatory and clinical strategy & operations infrastructure with the addition of key consulting agencies with significant track records in rare pediatric cancer, Priority Review Voucher (PRV) program approvals, and worldwide Conditional Market Access Applications including in the EU and UK.
The Company reiterates its commitment to seeking to obtain FDA approval for OST-HER2 in the rare pediatric cancer osteosarcoma in 2025. The Company is eligible to receive a Priority Review Voucher (PRV) if OST-HER2 is approved under its Rare Pediatric Disease Designation (RPDD) by September 30, 2026.
The Company has sufficient cash on hand to operate into 2026.
Potential Treatment Response Biomarkers from Canine Osteosarcoma Program
The Company’s canine osteosarcoma program recently made significant progress in understanding which biomarkers likely drive anti-tumor activity in prevention of recurrence of metastases, metastasis treatment (lung resection is not standard of care in canines) and primary tumor treatment to achieve limb sparing in dogs. The data generated creates the potential for the eventual expansion of the uses of OST-HER2 in osteosarcoma into treatment of unresectable lung metastases and limb sparing prior to surgical resection.
The Company intends to evaluate these biomarkers as potentially predictive of treatment response in humans in preparation for regulatory discussions with FDA, MHRA and EMA. Canine equivalent biomarkers have previously been used as surrogate endpoints for rare diseases in Comparative Oncology, which is the study of diseases that occur in humans and animals and have significant genetic homology. Human and Canine osteosarcoma have 96% genetic homology.
The Company is preparing to initiate regulatory correspondence with the United States Department of Agriculture (USDA) with the Company’s updated manufacturing process which incorporates key improvements covered under a patent that was recently granted a notice of allowance by the United States Patent & Trademark Office (USPTO).
Shelter Me is a film that was produced to highlight the important role of human and canine Comparative Oncology disease research. The movie will premiere on April 3, 2025 at AMC Century City in Los Angeles and will later be available to stream through the PBS app and on PBS.org.