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OS Therapies Announces Positive Data for OST-HER2 in the Treatment of Unresected Osteosarcoma in Dogs Opening the Potential for Use as Front-Line Therapy in Humans
Newsfile· 2025-04-10 11:40
Core Viewpoint - OS Therapies has announced positive data for its treatment OST-HER2 in dogs with unresected osteosarcoma, indicating potential for use as a frontline therapy in humans, aiming to prevent or delay limb amputation and reduce the need for chemotherapy [2][4][8] Group 1: Treatment Efficacy - OST-HER2 combined with palliative radiation showed clinical and radiographic arrest of primary tumors in dogs, leading to prolonged time to metastasis without surgery or chemotherapy [2][4] - The treatment demonstrated a significant improvement in overall survival, with 5 out of 15 dogs surviving over 500 days [6] - Positive data published in "Molecular Therapy" correlates immune responses to OST-HER2 with prevention of metastasis and long-term survival benefits [3][6] Group 2: Safety and Tolerability - Treatment with OST-HER2 was found to be safe and well tolerated in both studies conducted [4][6] Group 3: Future Plans and Approvals - The company plans to submit data to the USDA for conditional approval of the new manufacturing process for OST-HER2, aiming for sales to begin in 2025 [7] - A pivotal clinical study is planned to gain full approval by 2026 [7] - The company is focused on obtaining Accelerated Approval for OST-HER2 in recurrent, fully resected, lung metastatic human osteosarcoma by the end of 2025 [8] Group 4: Company Background - OS Therapies is a clinical-stage oncology company specializing in treatments for osteosarcoma and other solid tumors, with OST-HER2 as its lead asset [9] - The company has received various designations from the FDA, including Rare Pediatric Disease Designation and Fast-Track status [9] - OST-HER2 has shown statistically significant benefits in previous clinical trials for lung metastatic osteosarcoma [9]
ADC Therapeutics to Participate in the 24th Annual Needham Virtual Healthcare Conference
Prnewswire· 2025-04-01 11:15
Company Overview - ADC Therapeutics SA is a commercial-stage global leader in the field of antibody drug conjugates (ADCs) [3] - The company is focused on transforming treatment paradigms for patients with hematologic malignancies and solid tumors [3] Recent Developments - CEO Ameet Mallik will present a company overview at the 24th Annual Needham Virtual Healthcare Conference on April 8, 2025, at 8:00 a.m. ET [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for approximately 30 days [2] Product Pipeline - ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy [4] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy [4] - The company has multiple ADCs in ongoing clinical and preclinical development [4] Company Operations - ADC Therapeutics is headquartered in Lausanne, Switzerland, with operations in London, the San Francisco Bay Area, and New Jersey [5]
MacroGenics(MGNX) - 2024 Q4 - Earnings Call Transcript
2025-03-20 23:09
MacroGenics, Inc. (NASDAQ:MGNX) Q4 2024 Earnings Conference Call March 20, 2025 4:30 PM ET Company Participants James Karrels - SVP, CFO and Secretary Scott Koenig - President and CEO Stephen Eck - SVP, Clinical Development & Chief Medical Officer Conference Call Participants Peter Lawson - Barclays Jonathan Chang - Leerink Partners Nicholas Lorusso - TD Cowen Jonathan Miller - Evercore ISI Stephen Willey - Stifel Silvan Tuerkcan - Citizens JMP Securities Mayank Mamtani - B. Riley Securities Operator Good a ...
Zymeworks(ZYME) - 2024 Q4 - Earnings Call Transcript
2025-03-06 01:43
Zymeworks Inc. (NASDAQ:ZYME) Q4 2024 Earnings Conference Call March 5, 2025 4:30 PM ET Company Participants Shrinal Inamdar - Director, Investor Relations Leone Patterson - Executive Vice President, Chief Business and Financial Officer Paul Moore - Chief Scientific Officer Kenneth Galbraith - Chair and Chief Executive Officer Conference Call Participants Stephen Willey - Stifel Yigal Nochomovitz - Citi Brian Cheng - JPMorgan Jonathan Miller - Evercore ISI Jay Olson - Oppenheimer & Co. Justin Zelin - BTIG Op ...