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NEW YORK - OS Therapies Incorporated (NYSE American: OSTX), a biopharmaceutical company specializing in antibody-drug conjugates (ADCs) and immunotherapies, has announced the completion of treatment dosing for the last patient in its AOST-2121 clinical trial of OST-HER2 for recurrent osteosarcoma. The final participant is slated to undergo a radiological imaging evaluation early in the fourth quarter of 2024, as part of a 12-month Event Free Survival (EFS) analysis, which is the primary endpoint of the study.
OST-HER2 is an off-the-shelf immunotherapeutic vaccine based on a Listeria monocytogenes vector, aimed at preventing metastasis, delaying recurrence, and improving survival rates in osteosarcoma patients. The AOST-2121 study has enrolled a total of 41 patients across 21 clinical trial sites in the United States, all of whom have received 16 doses of OST-HER2 every three weeks over a 52-week period. The treatment is designed to stimulate both innate and adaptive immune responses, generating T-cells that target and destroy HER2-expressing tumor cells, potentially slowing or eliminating micro-metastases that can lead to recurrent disease.
The primary goals of the AOST-2121 trial include demonstrating EFS at 12 months and Overall Survival at 36 months, with interim survival endpoints at 12 and 24 months. The company expects to report topline EFS data, interim 2-year Overall Survival data, and additional secondary data analyses in the fourth quarter of 2024. This data will supplement interim findings presented at the ASCO 2024 conference.
OS Therapies has emphasized the lack of FDA-approved adjuvant treatments for recurrent osteosarcoma in the United States, noting that there have been no significant therapeutic advancements in over four decades. The finalization of dosing in the AOST-2121 trial marks a significant step towards potentially filling this therapeutic void.
The company also plans to focus on breast cancer following the osteosarcoma trial, leveraging the experience gained from its Phase I clinical data in breast cancer patients. OS Therapies continues to develop its next-generation tunable ADC platform, which allows for the delivery of multiple payloads per linker.
This announcement is based on a press release statement and is intended to provide an overview of OS Therapies' recent clinical trial developments. The company has cautioned that forward-looking statements within the release are subject to risks and uncertainties and that actual results may differ materially from those projected.
In other recent news, OS Therapies, Inc. has made significant strides in the development of its cancer immunotherapy drug, OST-HER2, and its next-generation Antibody Drug Conjugate (ADC) platform, OST-tADC. Brookline Capital Markets initiated coverage of the company, assigning a Buy rating and a price target of $9.00, emphasizing the potential of these technologies in treating osteosarcoma and other solid cancers. The firm also anticipates a Biologics License Application for OST-HER2 could be filed by mid-2025, with possible approval by late 2026.
Furthermore, OS Therapies announced the creation of a Patient Advocacy Advisory Board for its osteosarcoma program, aiming to provide insights from the osteosarcoma community for discussions with the FDA. This development follows the positive results from the Phase 1b trial of OST-HER2 in treating HER2-positive solid tumors, including breast cancer.
The company also reported that the OST-HER2 immunotherapy was safe and well-tolerated in the Phase 1b trial. In preclinical studies, OST-HER2 demonstrated significant reduction in tumor size and success in preventing breast cancer. The company now seeks Breakthrough Therapy Designation based on Phase IIb clinical trial data. These developments underscore the company's commitment to advancing treatments for osteosarcoma and other solid cancers.
InvestingPro Insights
As OS Therapies Incorporated (NYSE American: OSTX) reaches a pivotal milestone with the completion of treatment dosing for its AOST-2121 clinical trial, investors and stakeholders are closely monitoring the company's financial health and stock performance. With a market capitalization of $76.02 million, OSTX presents an interesting case for those considering biopharmaceutical investments.
Recent data from InvestingPro shows a significant 45.02% total return on the stock price over the last month, indicating a strong short-term performance. This trend extends over the last three and six months, with identical returns, suggesting a robust recovery from previous lows. Despite these gains, an InvestingPro Tip highlights the stock's high price volatility, which potential investors should consider when evaluating the company's shares.
On the financial side, the company's challenges are evident with negative gross profit margins reported over the last twelve months as of Q2 2024, reflecting a gross profit of -$0.01 million. This is compounded by an operating loss of -$3.19 million, which aligns with another InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year. Moreover, the price-to-earnings (P/E) ratio stands at -6.74, with an adjusted P/E ratio of -11.61 for the same period, underscoring the company's current lack of profitability.
For investors seeking more in-depth analysis, there are additional InvestingPro Tips available on the platform. These tips offer valuable insights into company specifics, such as financial health, stock performance predictions, and industry comparisons, which can be accessed at https://www.investing.com/pro/OSTX.
As OS Therapies forges ahead with its clinical developments, the InvestingPro platform remains a critical resource for real-time data and expert analysis that can help investors make informed decisions.
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