OS Therapies, Inc. (NYSE-A: OSTX) has announced the anticipated release of topline data from its Phase 2b clinical trial of OST-HER2 in patients with resected, recurrent osteosarcoma in December 2024. This immunotherapy is being developed for patients who currently have limited treatment options.
Paul Romness, MHP, Chairman & CEO of OS Therapies, stated, "We are now looking forward to releasing topline data in December and then engaging with the FDA regarding getting this potentially life-saving cancer immunotherapy to patients that have no other potential treatment options as quickly as possible."
OST-HER2: A Novel Immunotherapy Approach
OST-HER2 is a cancer immunotherapy biologic drug candidate composed of a HER2 bioengineered form of Listeria monocytogenes (Lm). It is designed to infect HER2-presenting cancer cells, triggering a robust immune response. The treatment aims to prevent metastasis, delay recurrence, kill primary tumors expressing HER2, and ultimately increase overall survival.
The company has completed the enrollment and treatment of all 41 patients in the Phase 2b clinical trial across 21 sites in the United States. The study focuses on patients with recurred, resected osteosarcoma.
Regulatory Designations and Potential Benefits
OST-HER2 has been granted Rare Pediatric Disease Designation (RPDD) by the FDA, along with Fast Track and Orphan Drug Designations by both the FDA and the European Medicines Agency (EMA). OS Therapies is currently in discussions with the FDA regarding Breakthrough Therapy Designation for OST-HER2. The RPDD could lead to a Priority Review Voucher upon Biologics Licensing Authorization (BLA) approval for osteosarcoma.
Additional Developments
Beyond osteosarcoma, OST-HER2 has completed a Phase 1 clinical trial primarily involving breast cancer patients. Preclinical data have demonstrated its efficacy both as a standalone treatment and in combination with HER2-targeting therapeutic antibodies like Herceptin.
OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company’s proprietary silicone linker technology, enabling the delivery of multiple payloads per linker.
Financial Overview
OS Therapies reported a net operating loss of $2.875 million for the third quarter of 2024, compared to $2.006 million in the same period in 2023. The increase in net loss was primarily attributed to expenses related to the initial public offering. The company anticipates generating revenue through the sale of a priority review voucher and licensing rights to its products and product candidates.
