OS Therapies Partners with EVERSANA for the U.S. Commercialization of OST-HER2 in Recurrent, Fully Resected, Pediatric Lung Metastatic Osteosarcoma

Rhea-AI Summary

OS Therapies (NYSE-A: OSTX) has partnered with EVERSANA to commercialize OST-HER2, a groundbreaking immunotherapy for pediatric lung metastatic osteosarcoma. OST-HER2 is the first potential new treatment in over 40 years for this rare and aggressive bone cancer. The therapy has received multiple FDA designations including Orphan, Fast Track, and Rare Pediatric Disease. A Biologics License Application rolling submission is planned for Q3 2025, with potential approval by year-end. EVERSANA will provide comprehensive commercialization services through its ONCOLOGY model, including market access, medical affairs, and patient services. OS Therapies recently secured U.S. Patent #12,239,738, providing manufacturing exclusivity for OST-HER2 and its Listeria-based platform through 2040.

Positive

• First potential new treatment for pediatric osteosarcoma in over 40 years
• Multiple FDA designations received (Orphan, Fast Track, Rare Pediatric Disease)
• Patent protection secured until 2040 for manufacturing exclusivity
• Cost-effective commercialization strategy through EVERSANA partnership
• Potential FDA approval by end of 2025

Negative

• Significant pre-BLA costs and infrastructure requirements
• Rolling BLA submission not yet started
• No revenue generation until potential approval

Insights

Biotechnology Commercialization Strategist

OS Therapies partners with EVERSANA for commercialization of OST-HER2, a potentially groundbreaking osteosarcoma treatment with FDA fast-track status.

This partnership represents a strategically significant milestone for OS Therapies as they prepare to commercialize OST-HER2, the first potential new treatment for pediatric osteosarcoma in over 40 years. The selection of EVERSANA provides immediate access to established commercial infrastructure without the substantial capital investment typically required to build these capabilities internally. This capital-efficient approach is particularly valuable for clinical-stage biotechs like OS Therapies.

The timing is critical, with a rolling BLA submission targeted for Q3 2025 and potential approval by year-end 2025. The drug's triple regulatory designations (Orphan, Fast Track, and Rare Pediatric Disease) from the FDA indicate both the unmet medical need and potential for expedited review. These designations typically confer benefits including tax credits, extended market exclusivity, and potentially a valuable Priority Review Voucher upon approval.

The recent patent issuance (#12,239,738) securing exclusivity through 2040 significantly strengthens OS Therapies' commercial position, protecting not just OST-HER2 but their broader Listeria-based immunotherapy platform. This intellectual property protection, combined with EVERSANA's end-to-end commercialization capabilities, positions OS Therapies to maximize the commercial potential while maintaining a lean operational structure pre-approval.

EVERSANA's specialized oncology commercialization model will be crucial for navigating the complex stakeholder landscape in rare pediatric cancers, where physician education and patient access are particularly challenging. The mention of potential applications in additional HER2-positive cancers suggests a strategic pathway for indication expansion beyond the initial osteosarcoma focus.

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 eversana.com or connect through LinkedIn and X. 

About OS Therapies
OS 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 www.ostherapies.com.

Forward-Looking Statements
Statements 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 EVERSANA
Matt Braun
Vice President, Corporate Communications
matt.braun@eversana.com 

For OS Therapies
Jack Doll
+1-410-297-7793
Irpr@ostherapies.com

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SOURCE EVERSANA

FAQ

What is the potential approval timeline for OSTX's OST-HER2 therapy?

OS Therapies plans to begin rolling BLA submission in Q3 2025, with potential FDA approval expected by the end of 2025.

What FDA designations has OST-HER2 received?

OST-HER2 has received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the FDA.

How long does OS Therapies' patent protection for OST-HER2 last?

OS Therapies secured U.S. Patent #12,239,738, providing manufacturing exclusivity for OST-HER2 through 2040.

What is OSTX's commercialization strategy for OST-HER2?

OS Therapies partnered with EVERSANA to provide end-to-end commercialization services, including market access, medical affairs, field deployment, and patient services.

What type of cancer does OST-HER2 treat?

OST-HER2 treats recurrent, fully resected, pediatric lung metastatic osteosarcoma, a rare and aggressive bone cancer affecting children and adolescents.