OS Therapies Inc (NYSE-A: OSTX), a clinical-stage biotechnology company focused on immunotherapies and targeted drug conjugates for cancer treatment, on Wednesday reported positive results from its Phase 2b clinical trial of OST-HER2 (OST31-164), an immunotherapy targeting HER2 for the prevention of recurrent, fully resected lung metastatic osteosarcoma.
The trial demonstrated a statistically significant 33.3% Event-Free Survival (EFS) at 12 months for OST-HER2-treated patients, compared to 20% in the historical control group (p = 0.0158). Further interim analyses show strong trends in favor of OST-HER2 for overall survival (OS), with 91% surviving at 1 year and 61% at 2 years.
Notably, all patients who achieved the 12-month EFS remain alive in follow-up. The treatment was well tolerated and safe. OST-HER2 is being developed for a rare paediatric cancer indication, osteosarcoma, with no currently approved treatments for this condition. The treatment leverages a bioengineered form of Listeria monocytogenes to stimulate a strong immune response against cancer cells expressing HER2.
OST-HER2 has received several designations from the FDA, including Rare Pediatric Disease Designation, and is expected to provide significant opportunities in the osteosarcoma market, estimated to be worth over USD500m in lung metastasis prevention alone. OS Therapies is also exploring the sale of a Priority Review Voucher (PRV), which could provide additional value for the company upon approval of OST-HER2.
Amgen's LUMAKRAS (sotorasib) in combination with Vectibix (panitumumab receives US FDA approval
Telix Pharmaceuticals' Illuccix gets European approval
Innovent and ASK Pharm's limertinib NDA receives Chinese regulatory approval
RYBREVANT approved in Canada for second-line EGFR-mutated lung cancer
Avacta Group reports positive data from AVA6000 Phase 1 trial in salivary gland cancer
Axcynsis Therapeutics' IND for AT03-65 receives US FDA approval
Innovent Biologics' IBI343 receives Breakthrough Therapy Designation in China
OS Therapies reports positive Phase 2b data for OST-HER2 in lung metastatic osteosarcoma
Johnson & Johnson submits New Drug Application for TAR-200 to treat bladder cancer
Creo Medical Group plc launches robotic-guided lung ablation procedures in the UK
Phase I/II clinical trial of Ariceum Therapeutics' 225Ac-SSO110 gets US FDA approval
Adaptive Biotechnologies and NeoGenomics partner to expand MRD monitoring for blood cancer
HUTCHMED receives full NMPA approval for ORPATHYS in China for MET exon 14 skipping NSCLC
Vascarta collaborates with City College of New York to improve efficacy and safety of chemotherapy