OS Therapies, Inc. (NYSE-A: OSTX) has announced the completion of patient dosing in its Phase 2b clinical trial evaluating OST-HER2 for the treatment of resected, recurrent osteosarcoma. The company anticipates releasing topline data from the trial in December 2024, a key milestone in the development of this novel cancer immunotherapy.
The Phase 2b trial enrolled 41 patients across 21 clinical trial sites in the United States. OST-HER2, the company's lead product candidate, is a bioengineered form of Listeria monocytogenes designed to target and infect HER2-expressing cancer cells, triggering a strong immune response. This off-the-shelf treatment aims to prevent metastasis, delay recurrence, kill primary tumors, and increase overall survival in patients with osteosarcoma.
Financial Update
In conjunction with the clinical trial update, OS Therapies reported its financial results for the third quarter of 2024. The company recorded a net operating loss of $2.875 million, compared to a loss of $2.006 million in the same period of 2023. The increased loss was primarily attributed to expenses associated with the company's initial public offering (IPO). Despite the current pre-revenue status, OS Therapies anticipates generating revenue through the potential sale of a Priority Review Voucher (PRV) upon FDA approval of OST-HER2 and through licensing agreements as clinical and regulatory milestones are achieved.
Regulatory Designations and Future Prospects
OST-HER2 has been granted Rare Pediatric Disease Designation, Fast Track Designation, and Orphan Drug Designation by both the FDA and the European Medicines Agency (EMA). These designations offer potential benefits, including accelerated review processes and market exclusivity. OS Therapies is also in active discussions with the FDA regarding Breakthrough Therapy Designation for OST-HER2, which could further expedite its development and approval.
"The third quarter was pivotal for OS Therapies as we completed our initial public offering and finished dosing the final patient enrolled in our Phase 2b clinical trial of OST-HER2 in resected, recurrent osteosarcoma," said Paul Romness, MHP, Chairman & CEO of OS Therapies. "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 leverages a unique mechanism of action, utilizing a HER2 bioengineered form of Listeria monocytogenes to selectively target and destroy HER2-expressing cancer cells. Preclinical data has demonstrated efficacy both as a standalone therapy and in combination with HER2-targeting therapeutic antibodies such as Herceptin. Furthermore, OST-HER2 has completed a Phase 1 clinical trial primarily in breast cancer patients, suggesting broader therapeutic potential beyond osteosarcoma.
