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OS Therapies Announces Statistically Significant Positive Final 2-Year Overall Survival Data from Phase 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully-Resected, Pulmonary Metastatic Osteosarcoma
Newsfile· 2025-10-10 10:00
Core Insights - OS Therapies announced statistically significant positive final 2-year overall survival data from the Phase 2b trial of OST-HER2, showing 75% of treated patients achieved 2-year overall survival compared to 40% in historical controls [1][4] - The company is on track to file for conditional marketing authorization in the UK, the US, and the EU, with key regulatory meetings planned for December 2025 [3][6] Group 1: Clinical Trial Results - 75% of OST-HER2 treated patients achieved 2-year overall survival, significantly higher than the 40% in historical controls (p < 0.0001) [1][4] - Subgroup analysis indicated that 100% of patients who achieved 12-month Event Free Survival (EFS) also achieved 2-year overall survival [1][4] Group 2: Regulatory Path and Future Plans - The company plans to submit a conditional Marketing Authorization Application (MAA) to the MHRA in December 2025 and a Biologics Licensing Application (BLA) to the FDA in January 2026 [3][6] - OS Therapies is analyzing patient samples to confirm correlations between clinical outcomes and immune system biomarker activation, with results expected in November 2025 [3] Group 3: Company Overview and Product Pipeline - OS Therapies focuses on developing treatments for Osteosarcoma and other solid tumors, with OST-HER2 as its lead asset, which has received multiple designations from regulatory agencies [6][7] - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced treatment delivery [7]
OS Therapies to Participate in Fall 2025 Conferences and Events
Newsfile· 2025-10-07 15:50
Core Insights - OS Therapies is actively participating in multiple conferences and events in October 2025, showcasing its commitment to advancing cancer treatment and engaging with industry stakeholders [1][2][3][4][5]. Company Overview - OS Therapies Inc. is a clinical-stage biotechnology company focused on developing treatments for Osteosarcoma and other solid tumors, with its lead asset being OST-HER2, an immunotherapy targeting the HER2 protein [5][6]. - OST-HER2 has received several designations from the U.S. FDA, including Rare Pediatric Disease Designation, Fast-Track, and Orphan Drug designations, indicating its potential significance in treating rare diseases [5]. - The company reported positive results from its Phase 2b clinical trial of OST-HER2, demonstrating statistically significant benefits in the 12-month event-free survival primary endpoint for patients with recurrent, fully resected, lung metastatic osteosarcoma [5]. Upcoming Events - OS Therapies will participate in the Cell and Gene Meeting on the Mesa from October 6-8, 2025, in Phoenix, AZ, focusing on partnering and one-on-one meetings [2]. - The company will also attend the Roth Annual Healthcare Opportunities Conference on October 9, 2025, in New York City, where it will engage in meetings with potential investors [2]. - A workshop on advancing osteosarcoma drug development will take place on October 10, 2025, in Washington, DC, where OS Therapies management will be available for discussions [2]. - The BIOFuture 2025 event is scheduled for October 13-15, 2025, in New York City, featuring a spotlight panel and one-on-one meetings [3]. - The company will be present at the 52nd Daytime Emmy Awards on October 17, 2025, where its documentary "Shelter Me: Cancer Pioneers" has received two nominations [3]. - The Maxim Growth Summit will occur on October 22, 2025, in New York City, where corporate presentations and meetings will be held [4]. - OS Therapies will also participate in BIO - Europe from November 3-5, 2025, in Vienna, Austria, focusing on partnering and meetings [5]. Product Development - OST-HER2 has shown preclinical efficacy in various models of breast cancer and has been conditionally approved by the U.S. Department of Agriculture for treating canines with osteosarcoma [5]. - The company is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [6].
Liminatus Pharma Inc. to Launch “American BNB Strategy” Subsidiary and Target Up To $500 Million Fund for BNB Investment as Part of Crypto Market Initiative
Globenewswire· 2025-07-28 11:30
Core Viewpoint - Liminatus Pharma, Inc. plans to strategically expand into the cryptocurrency sector by establishing a subsidiary focused on accumulating BNB Coin, with a target investment of up to $500 million for long-term value [1][2][4]. Company Strategy - The new subsidiary, "American BNB Strategy," will lead the digital asset investment initiatives, aiming to raise and deploy capital in phases [2][4]. - The investment strategy is characterized as a long-term value-driven approach rather than a short-term speculative initiative [4][5]. Rationale for Investment - BNB Coin was chosen due to its robust technology, global user base, and value-generating features such as Launchpool participation and staking models [5]. - The company believes that entering the digital asset space is essential for long-term growth and enhancing shareholder value while remaining committed to its core business of cancer therapeutics [3][6]. Operational Framework - Liminatus plans to utilize custody infrastructure from Ceffu, an entity within the BNB ecosystem, to ensure security and operational integrity in its digital asset investments [6]. - The company is currently engaged in a capital raise process with placement agent Digital Offering, pending regulatory clearance and market conditions [8]. Industry Impact - This initiative marks a rare move for a traditional biopharmaceutical company, potentially setting a precedent for how other Nasdaq-listed companies engage with the digital asset economy [7].