Zinger Key Points
- OST-HER2 achieved a 33% 12-month event-free survival vs. 20% for historical control (p=0.0158).
- 1-year survival rate reached 91% for OST-HER2 vs. 80% for control (p=0.07).
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On Wednesday, OS Therapies, Inc. OSTX 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.
Notably, all patients who achieved the primary 12-month EFS endpoint remain alive.
“We are extremely pleased with these results of our Phase 2b clinical trial because they show that OST-HER2-treated patients achieved the primary endpoint of 12-month EFS in a statistically significantly higher ratio than comparable historical controls, in addition to increasing the likelihood of 1-year and 2-year survival as compared with comparable historical controls,” commented Robert Petit, Chief Medical & Scientific Officer of OS Therapies.
Primary Endpoint of 12-month EFS:
- 33% for OST-HER2 vs. 20% for historical control (p=0.0158)
Interim Analysis of Ongoing Secondary Endpoint, Overall Survival:
- 1-year: 91% for OST-HER2 vs. 80% for historical control (p=0.07) and 61% vs. 40% for 2-year (p = 0.0576).
Recently, OS Therapies closed a private placement financing, raising approximately $6 million in gross proceeds.
The company will use the proceeds for working capital, primarily on clinical and regulatory milestones, to support the commercialization of its lead therapeutic candidate, OST-HER2.
Price Action: OSTX stock is up 7.96% at $4.49 at last check Wednesday.
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