OS Therapies Completes Enrollment in OST-HER2 Trial for Osteosarcoma

OS Therapies Marks a Milestone in Osteosarcoma Treatment

OS Therapies (NYSE American: OSTX), a pioneering company in immunotherapy and biopharmaceuticals, has recently announced a significant achievement in its clinical research. The final patient enrolled in the AOST-2121 Phase 2b clinical trial for its innovative treatment OST-HER2 has completed their last visit. This momentous occasion marks the conclusion of a dedicated treatment period that has aimed at addressing the challenges of osteosarcoma, a particularly aggressive form of cancer that is notably difficult to treat.

Details of the AOST-2121 Clinical Trial

The clinical trial, which involved a total of 41 patients battling recurrent, resected osteosarcoma, consisted of administering the OST-HER2 treatment—a biologic candidate designed to leverage the body's immune response. Participants received 16 doses over the course of approximately 52 weeks. Throughout this time, the focus has been on evaluating their radiographic responses, with critical assessments at various stages of the treatment.

One key aspect of this study is to understand OST-HER2's effectiveness in preventing metastasis and delaying recurrences in patients who are highly predisposed to further cancerous developments. Results from this trial will provide insights into Event Free Survival (EFS) and Overall Survival (OS), crucial factors that can help shape future treatment protocols for osteosarcoma.

Strategic Engagement with Regulatory Authorities

In the wake of this successful trial completion, OS Therapies is preparing to request a Type C Meeting with the U.S. Food and Drug Administration (FDA). This meeting is a critical step as it will enable the company to discuss potential protocol amendments based on FDA feedback. After these adjustments, OS Therapies plans to lock the clinical trial database, preparing for a comprehensive data analysis and topline results anticipated in the forthcoming months.

Leading The Charge on Osteosarcoma

OST-HER2 is designed with a unique mechanism of action involving a Lm (Listeria monocytogenes) vector, which is expected to elicit robust immune responses against the cancer. By generating targeted T-cells, the therapy aims to attack and destroy cells harboring the HER2 protein, known to be associated with tumor growth—thereby preventing recurrence and promoting longer overall survival rates.

Despite advancements in cancer therapies, there remain no approved adjuvant treatments for recurrent osteosarcoma in the United States, highlighting the importance of this research. OS Therapies is not only advancing its clinical studies but is also striving to innovate within its treatment paradigms.

Upcoming Public Engagements and Insights

Adding to the excitement of the trial's conclusion, OS Therapies is scheduled to ring the closing bell at the New York Stock Exchange. Paul Romness, President and CEO of the company, will also be engaging the public through two live television interviews aimed at addressing the implications of their latest trial results and future directions of the company.

These interviews are not only a platform for sharing their success but also an opportunity to educate the public about the ongoing fight against osteosarcoma and the potential for novel immunotherapies like OST-HER2.

About OS Therapies

OS Therapies stands at the forefront of oncological advancement with its focus on developing effective treatments for osteosarcoma and other solid tumors. Their flagship drug, OST-HER2, harnesses the body's immune system via the use of Listeria bacteria to generate a powerful immune response targeting cancer cells. Recent developments in the company, including a conditional approval for the treatment of canines with osteosarcoma and advancements in their Antibody Drug Conjugate (ADC) platform, underscore their commitment to innovation in cancer treatment.

Frequently Asked Questions

What does the OST-HER2 treatment aim to achieve?

OST-HER2 aims to prevent metastasis, delay recurrence, and enhance overall survival in patients with osteosarcoma.

How many patients participated in the AOST-2121 trial?

The AOST-2121 clinical trial included 41 patients treated with OST-HER2.

What is the unique mechanism behind OST-HER2?

OST-HER2 utilizes a Listeria-based vector to stimulate T-cell responses against cancer cells, particularly targeting HER2 proteins.

When are the results of the trial expected?

The topline data readout from the AOST-2121 trial is anticipated in the fourth quarter of 2024.

How is OS Therapies engaging with the FDA?

OS Therapies is preparing for a Type C Meeting with the FDA to discuss potential protocol adjustments based on their recommendations.

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