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Yahoo
10-06-2025
- Business
- Yahoo
OS Therapies Partners with EVERSANA for the U.S. Commercialization of OST-HER2 in Recurrent, Fully Resected, Pediatric Lung Metastatic Osteosarcoma
NEW YORK and CHICAGO, June 10, 2025 /PRNewswire/ -- OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, has selected EVERSANA®, a leading provider of global commercial services to the life sciences industry, to support the U.S. commercialization of OST-HER2, a novel immunotherapy for recurrent, fully resected, pediatric lung metastatic osteosarcoma. OST-HER2, a Listeria monocytogenes-based immunotherapy, is the first potential new treatment in over 40 years for pediatric osteosarcoma, a rare, aggressive bone cancer that often metastasizes to the lungs, primarily affecting children and adolescents. The therapy has received Orphan, Fast Track and Rare Pediatric Disease Designations from the U.S. Food and Drug Administration (FDA), with a Biologics License Application (BLA) rolling submission targeted to begin in the third quarter of 2025, with potential approval coming as early as year end 2025. "Working with EVERSANA ensures we have the infrastructure, expertise and agility to bring OST-HER2 to patients and families who have long awaited new options without the need to spend significant capital building our own commercial infrastructure," said Paul Romness, CEO of OS Therapies. "By leveraging EVERSANA's flexible integrated commercialization operations and deep oncology experience, we will be able to rapidly and cost-effectively fulfill our mission of transforming the treatment landscape for pediatric metastatic osteosarcoma while judiciously managing pre-BLA costs." EVERSANA will activate its dedicated end-to-end EVERSANA ONCOLOGY Commercialization model, including market access, medical affairs, field deployment, patient services and stakeholder engagement. The fully integrated platform accelerates awareness and access to OST-HER2 among healthcare providers treating osteosarcoma, as well as the potential to treat additional HER2-positive cancers. "We share OS Therapies' relentless commitment to helping patients facing the devastating diagnosis of cancer," said Jim Lang, CEO at EVERSANA. "We've activated the full scale of our commercialization operation and global team of oncology experts to bring this much-needed innovation to market. This product is just the beginning of OS Therapies' impact for patients around the world." The announcement follows OS Therapies' recent issuance of U.S. Patent #12,239,738, securing commercial manufacturing exclusivity for OST-HER2 and its broader Listeria-based immunotherapy platform through 2040. About EVERSANA EVERSANA® is a leading independent provider of global services to the life sciences industry. The company's integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit or connect through LinkedIn and X. About OS TherapiesOS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for osteosarcoma and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company has demonstrated positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a BLA to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit Forward-Looking StatementsStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and other risks and uncertainties described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's most recent Annual Report on Form 10-K and other subsequent documents the Company files with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Media Contacts For EVERSANAMatt BraunVice President, Corporate For OS TherapiesJack Doll+1-410-297-7793Irpr@ View original content to download multimedia: SOURCE EVERSANA Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
20-02-2025
- Business
- Associated Press
Amarc To Showcase the 'AuRORA' High Grade Cu-Au-Ag Discovery at PDAC
President and CEO Dr. Diane Nicolson and the Senior Technical Team will be available to discuss Amarc's Cu-Au Districts, and to view drill core from AuRORA porphyry discovery at Booth #2085 Dr. Jim Lang, renowned porphyry expert, is to give a technical presentation on the AuRORA discovery, Sunday March 2, 2025, at 2:20 pm EST in Room #716 VANCOUVER, BC / ACCESS Newswire / February 20, 2025 / Amarc Resources Ltd. ('Amarc' or the 'Company') (TSXV:AHR)(OTCQB:AXREF) is pleased to announce its upcoming participation at the 2025 Prospectors & Developers Association of Canada Conference ('PDAC') from March 2-5, 2025, Toronto, ON. Amarc will be showcasing the 100% owned 'AuRORA' high grade, gold-rich, porphyry copper-gold-silver ('Cu-Au-Ag') deposit discovery made in collaboration with Freeport-McMoran. Results from this important discovery within its 100% owned 495 km2 JOY District were announced January 17, 2025 and January 20, 2025. PDAC Details: Technical presentation by Dr. Jim Lang, Technical Advisor - Consultant PDAC attendees are invited to booth #2085 to meet with Dr. Diane Nicolson, alongside Hall of Fame Inductee Mark Rebagliati, and Dr. Jim Lang, P. Geo., to discuss the Company's JOY, DUKE and IKE Districts and to review drill core from the AuRORA discovery. 'PDAC is an excellent opportunity to discuss the outstanding potential that is emerging within all three of Amarc's Districts in British Columbia while further showcasing the importance of the AuRORA discovery on a global stage,' stated Dr. Diane Nicolson. 'We are excited to meet our shareholders and prospective investors to increase the awareness of Amarc, and share more about the 29,000 m of drilling in 2024 across all three of our highly prospective districts.' To arrange a meeting with management, conference delegates are encouraged to contact Diane Nicolson, Amarc President & CEO, at 778-388-4603 or [email protected] or KIN Communications, Investor Relations at [email protected] or 604-684-6730. About Amarc Resources Ltd. Amarc is a mineral exploration and development company with an experienced and successful management team focused on developing a new generation of long-life, high-value porphyry Cu-Au mines in BC. By combining high-demand projects with dynamic management, Amarc has created a solid platform to create value from its exploration and development-stage assets. Amarc is advancing its 100%-owned JOY, DUKE and IKE porphyry Cu±Au Districts located in different prolific porphyry regions of northern, central and southern BC, respectively. Each District represents significant potential for the development of multiple and important-scale, porphyry Cu±Au deposits. Importantly, each of the three districts are located in proximity to industrial infrastructure - including power, highways and rail. Amarc's exploration is led by an internationally successful team of experienced geologists specializing in porphyry Cu-Au deposits. Members of this team have been involved in and have tracked porphyry Cu-Au exploration advancements in the Toodoggone region since 1990. Their experience and early recognition of the porphyry potential at the NWG Target in terms of a shallowly overburden covered and underexplored transitional epithermal-porphyry geological setting, led to the discovery of the Au-rich AuRORA porphyry Cu-Au-Ag Deposit. Freeport-McMoRan Mineral Properties Canada Inc. ('Freeport'), a wholly owned subsidiary of Freeport-McMoRan Inc. at JOY and Boliden Mineral Canada Ltd. ('Boliden'), an entity within the Boliden Group of companies at DUKE, can earn up to a 70% interest in each District through staged investments of $110 million and $90 million, respectively. Together this provides Amarc with potentially up to $200 million in non-share dilutive staged funding for these Districts. In addition, Amarc has completed self-funded drilling at its higher-grade Empress Deposit in the IKE District. Amarc is the operator of all programs. Amarc is associated with HDI, a diversified, global mining company with a 35-year history of porphyry Cu deposit discovery, development and transaction success. Previous and current HDI projects include some of BC's and the world's most important porphyry deposits - such as Pebble, Mount Milligan, Southern Star, Kemess South, Kemess North, Gibraltar, Prosperity, Xietongmen, Newtongmen, Florence, Casino, Sisson, Maggie, AuRORA, PINE, IKE and DUKE. From its head office in Vancouver, Canada, HDI applies its unique strengths and capabilities to acquire, develop, operate and monetize mineral projects. Amarc works closely with local governments, Indigenous groups and stakeholders in order to advance its mineral projects responsibly, and in a manner that contributes to sustainable community and economic development. We pursue early and meaningful engagement to ensure our mineral exploration and development activities are well coordinated and broadly supported, address local priorities and concerns, and optimize opportunities for collaboration. In particular, we seek to establish mutually beneficial partnerships with Indigenous groups within whose traditional territories our projects are located, through the provision of jobs, training programs, contract opportunities, capacity funding agreements and sponsorship of community events. All Amarc work programs are carefully planned to achieve high levels of environmental and social performance. Mark Rebagliati, a Qualified Person ('QP') as defined by National Instrument 43-101, has reviewed and approved the technical information contained in this news release. Mr. Rebagliati is not independent of the Company. For further details on Amarc Resources Ltd., please visit the Company's website at or contact Dr. Diane Nicolson, President and CEO, at (778)-388-4603 or within North America at 1-800-667-2114, or Kin Communications, at (604) 684-6730, Email: [email protected]. ON BEHALF OF THE BOARD OF DIRECTORS OF AMARC RESOURCES LTD. Dr. Diane Nicolson President and CEO Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward-Looking and other Cautionary Information This news release includes certain statements that may be deemed 'forward-looking statements'. All such statements, other than statements of historical facts that address exploration plans and plans for enhanced relationships are forward-looking statements. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the forward-looking statements. Assumptions used by the Company to develop forward-looking statements include the following: Amarc's projects will obtain all required environmental and other permits and all land use and other licenses, studies and exploration of Amarc's projects will continue to be positive, and no geological or technical problems will occur. Factors that could cause actual results to differ materially from those in forward-looking statements include market prices, potential environmental issues or liabilities associated with exploration, development and mining activities, exploitation and exploration successes, continuity of mineralization, uncertainties related to the ability to obtain necessary permits, licenses and tenure and delays due to third party opposition, changes in and the effect of government policies regarding mining and natural resource exploration and exploitation, exploration and development of properties located within Aboriginal groups asserted territories may affect or be perceived to affect asserted aboriginal rights and title, which may cause permitting delays or opposition by Aboriginal groups, continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. For more information on Amarc Resources Ltd., investors should review Amarc's annual Form 20-F filing with the United States Securities and Exchange Commission at and its home jurisdiction filings that are available at
