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- OS Therapies reached incremental alignment with the FDA on an adaptive Phase 3 trial design for OST-HER2 previously agreed with the MHRA and EMA. - The company accepted an MHRA request to serve as its representative to Project Orbis, harmonizing oncology regulatory review across the US, UK and Europe. - The Phase 3 trial in fully-resected, pulmonary metastatic osteosarcoma is expected to begin in the fourth quarter of 2026. - OST-HER2 holds FDA Orphan Drug, Fast Track and Rare Pediatric Disease designations, with a Priority Review Voucher potentially available if approved.
- OS Therapies achieved full alignment with the UK MHRA and EU EMA on its conditional marketing authorisation applications for OST-HER2 in resected pulmonary metastatic osteosarcoma. - Regulators accepted historical-control overall survival data from peer-reviewed literature as appropriate for the orphan indication, supporting the pending submissions. - The company expects to complete the UK CMAA submission within weeks and to begin the required confirmatory Phase 3 trial in the fourth quarter of 2026. - OST-HER2 holds Orphan Drug, Fast Track and Rare Pediatric Disease designations in the US, with a BLA submission under FDA review since January 2026.
- OS Therapies appointed Craig Eagle, MD, Chief Medical Officer of Guardant Health, and Robert "Bob" Langer, PhD, co-founder of Moderna, to its newly-formed strategic advisory board in April 2026. - The advisory board will guide regulatory execution for OST-HER2 in osteosarcoma and help prioritize the company's clinical pipeline across multiple cancer indications. - OST-HER2 demonstrated statistically significant benefits in 12-month event-free survival and overall survival in its Phase 2b trial for recurrent, fully resected lung metastatic osteosarcoma. - The company anticipates receiving a Biologics License Application from the FDA for OST-HER2 in 2026, which could make it eligible for a Priority Review Voucher valued at approximately $205 million.
- The World Health Organization's International Nonproprietary Names Expert Committee approved 'daznelimgene lisbac' as the official non-proprietary name for OS Therapies' HER2-targeted listeria-based cancer immunotherapy OST-HER2. - OST-HER2 demonstrated statistically significant benefit in 12-month event-free survival in a Phase 2b trial for recurrent, fully resected, pulmonary metastatic osteosarcoma patients. - The company plans to seek regulatory feedback from US, UK, and European authorities in December 2025 and submit a Biologics License Application to the FDA in early 2026. - If approved, OS Therapies would be eligible for a Priority Review Voucher that could be sold, given OST-HER2's Rare Pediatric Disease Designation from the FDA.
- OS Therapies announced plans to spin off OS Animal Health as a standalone public company in the first half of 2026, focusing on OST-HER2 for canine osteosarcoma treatment. - OST-HER2 is a Listeria-based immunotherapy targeting HER2-positive cancers that has received conditional USDA approval for canine osteosarcoma and shows potential across multiple HER2-positive cancers. - The veterinary oncology market is projected to grow from $1.58 billion in 2024 to $4.77 billion in 2034, with canine osteosarcoma representing approximately $1.35 billion of the current market. - The spinoff will allow dedicated focus on veterinary applications while OS Therapies continues developing human therapies, addressing distinct regulatory requirements between human and animal biologics.
- The osteosarcoma market in the 7MM is expected to grow significantly by 2034, driven by extensive R&D activities and the entry of novel therapies including OST-HER2, Naxitamab 15-096, and HALMB-0168. - OS Therapies plans to submit a Biologics License Application for OST-HER2 to the US FDA by 2025, with the potential to receive a Priority Review Voucher upon approval. - The market faces challenges including chemotherapy resistance in approximately half of patients and limited treatment options for relapsed or refractory cases. - Currently, MEPACT (mifamurtide) remains the only approved therapy specifically for osteosarcoma, highlighting significant unmet medical needs in this rare cancer.
• OS Therapies' investigational immunotherapy OST-HER2 demonstrates statistically significant benefit in Phase 2b clinical trials for recurrent osteosarcoma, with FDA submission planned for 2025. • The treatment leverages Listeria bacteria to target HER2-expressing cancer cells and has received multiple regulatory designations including Rare Pediatric Disease Designation and Fast-Track status. • The innovative therapy will be featured in PBS documentary "Shelter Me: The Cancer Pioneers," highlighting the importance of comparative oncology between human and canine osteosarcoma, which share 96% genetic homology.
- OST-HER2 demonstrated a statistically significant 12-month event-free survival (EFS) rate of 33.3% compared to 20% in historical controls for recurrent, fully resected osteosarcoma with lung metastases. - Interim overall survival (OS) analysis showed a favorable trend for OST-HER2, with 1-year OS at 91% versus 80% in historical controls, and all patients achieving 12-month EFS remaining alive. - The Phase 2b trial's positive results support OS Therapies' plans to engage with the FDA for accelerated approval of OST-HER2 in this challenging indication with no currently approved therapies. - OST-HER2, a HER2-targeted immunotherapy, exhibited a strong safety profile in the study, further supporting its potential use in patients with recurrent lung metastatic osteosarcoma.
- OS Therapies has initiated commercial manufacturing for OST-HER2, an immunotherapy targeting HER2, in preparation for a BLA submission to the FDA. - The company completed a Phase 2b trial of OST-HER2 for recurrent lung metastatic osteosarcoma, with positive results reported in early 2025. - OS Therapies anticipates a Type B or Type C meeting with the FDA before submitting the BLA for accelerated or conditional approval. - A patent notice of allowance from the USPTO provides market exclusivity for OST-HER2 commercial drug product into 2040.
- OS Therapies has announced a $6 million private placement to fund the clinical and regulatory milestones for OST-HER2, its lead therapeutic candidate. - The funding is expected to extend the company's cash runway into 2026, supporting the commercialization efforts for recurrent, resected metastatic osteosarcoma. - Phase 2b data for OST-HER2 is anticipated to be presented at the JP Morgan Healthcare Conference in January 2025, marking a key milestone for the company. - The FDA has granted OST-HER2 rare pediatric disease, fast track, and orphan drug designations, potentially accelerating its regulatory pathway.
