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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