On Friday, OS Therapies, Inc. (NYSE-A: OSTX) entered into agreements for the commercial manufacture of OST-HER2.
The company is currently organizing additional data about the recently completed treatment phase of its Phase 2b trial of OST-HER2 to prevent recurrence of lung metastatic osteosarcoma in preparation for a Type B or Type C FDA.
Following the FDA meeting, the company anticipates submitting a Biologics Licensing Authorization (BLA) application to the FDA for accelerated or conditional approval consideration.
In January, OS Therapies revealed data from a Phase 2b trial of OST-HER2 (OST31-164), a HER2-targeted immunotherapy candidate in the rare pediatric-designated indication of prevention of recurrent, fully resected, lung metastatic osteosarcoma, a rare, cancerous bone tumor that develops in bone-forming cells.
The data demonstrate statistically significant results in the primary endpoint of the study, 12-month event-free survival (EFS), where an event is defined as the recurrence of metastatic osteosarcoma in OST-HER2-treated patients when compared with the published historical comparable control group.
Further, as of the most recent follow-up, the data show a strong trend in favor of OST-HER2-treated patients in overall survival (';OS,' remaining alive) at the 1-year and 2-year interim time points of the ongoing 3-year overall survival secondary endpoint.
In January, OS Therapies announced an asset purchase agreement to acquire the listeria monocytogenes-based immuno-oncology programs and related intellectual property (IP) assets from Ayala Pharmaceuticals.
OS Therapies will pay $0.5 million in cash and issue $7.5 million worth of common shares to Ayala.
OS Therapies previously disclosed that it completed a $7.1 million financing, priced at $4.00 per share, that provides the company with sufficient cash runway into 2026, including payments to Ayala.
Price Action: OSTX stock is up 28.6% at $2.58 at last check Friday.
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