OS Therapies Incorporated (NYSE-A: OSTX), a biopharmaceutical company specializing in Cancer Immunotherapy and Antibody Drug Conjugates (ADCs), announced the creation of a Patient Advocacy Advisory Board (PAAB) for its osteosarcoma program.
The PAAB will provide insights from the osteosarcoma community to inform discussions with the US Food & Drug Administration (FDA), particularly concerning a potential Biologics License Authorization (BLA) for the company's immunotherapeutic product candidate, OST-HER2.
The advisory board consists of individuals with direct experience in osteosarcoma, including Miriam Cohen, Mac Tichenor, Tony Trent, Olivia Egge, and Serena Subada. These members will not receive financial compensation and plan to convene quarterly to review progress in the company's clinical program.
OST-HER2, OS Therapies' lead product candidate, is an immunotherapy treatment designed to combat cancer cells expressing the HER2 protein by using a bioengineered form of the Listeria monocytogenes bacteria.
The treatment aims to prevent metastasis, delay recurrence, and increase overall survival. The company has completed enrollment for a Phase IIb clinical trial with 41 patients across 21 sites in the United States, with positive interim data reported in June 2024 and final data expected in the fourth quarter of 2024.
OS Therapies has obtained several designations from the FDA for OST-HER2, including Rare Pediatric Disease Designation, Fast Track, and Orphan Drug Designations, as well as Orphan Drug Designation from the European Medicines Agency (EMA). The company is now seeking Breakthrough Therapy Designation based on Phase IIb clinical trial data.
Osteosarcoma is a particularly aggressive cancer that primarily affects children and young adults. Despite the challenges in treatment due to location, changing genotypes, and high recurrence rates, standard treatment has remained limited to surgery and chemotherapy.
OS Therapies is a clinical-stage oncology company focused on the development of treatments for osteosarcoma and other solid tumors. Besides OST-HER2, the company is developing a tunable Antibody Drug Conjugate (tADC) platform, which features customizable antibody-linker-payload candidates.
InvestingPro Insights
As OS Therapies Incorporated (NYSE-A: OSTX) continues to make strides in the development of its osteosarcoma treatments, its market performance remains a key point of interest for investors. As of the last trading session, OS Therapies' stock price closed at 2.51 USD, giving market participants a recent benchmark for the company's valuation.
InvestingPro data highlights the average daily trading volume for OS Therapies over the past three months, which stands at 0.42 million shares. This metric provides insight into the liquidity of the stock and the level of investor interest in the company's progress and potential.
InvestingPro Tips suggest that investors pay close attention to the company's upcoming milestones, such as the final data from the Phase IIb clinical trial of OST-HER2 expected later this year. Positive results could significantly impact both the company's valuation and its stock price.
For those seeking further insights, InvestingPro offers additional tips on OS Therapies and other biopharmaceutical companies. Currently, there are 15 more InvestingPro Tips available that could help investors make more informed decisions about their investments in this sector.
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