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Osteosarcoma Pipeline 2025: MOA, ROA, FDA-Approved Drugs, and Clinical Trial Progress Assessment

09-24-2025 08:38 PM CET | Health & Medicine

Press release from: DelveInsight Business Research

Osteosarcoma Pipeline 2025: MOA, ROA, FDA-Approved Drugs,

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Osteosarcoma pipeline constitutes 25+ key companies continuously working towards developing 30+ Osteosarcoma treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Osteosarcoma Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

"Osteosarcoma Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Osteosarcoma Market.

Some of the key takeaways from the Osteosarcoma Pipeline Report: https://www.delveinsight.com/sample-request/osteosarcoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Osteosarcoma treatment therapies with a considerable amount of success over the years.
• Osteosarcoma companies working in the treatment market are Dana-Farber Cancer Institute, MedPacto, Inc., K-Group, Beta, Inc., H. Lee Moffitt Cancer Center, Hansoh BioMedical R&D Company, Ipsen, UNICANCER, Adaptimmune, M.D. Anderson Cancer Center, and others, are developing therapies for the Osteosarcoma treatment
• Emerging Osteosarcoma therapies in the different phases of clinical trials are- Olaparib, Vactosertib, ZN-c3, Nivolumab, HS-20093, Cabozantinib, cisplatin, Afamitresgene autoleucel, Aldesleukin, and others are expected to have a significant impact on the Osteosarcoma market in the coming years.
• In March 2025, OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotech developing immunotherapies and targeted drug conjugates for cancer, announced it has secured a presentation slot at the MIB Agents Factor Osteosarcoma Conference, scheduled for June 26-28, 2025, in Salt Lake City, Utah. The company will share key findings from its Phase 2b trial of OST-HER2, focused on preventing recurrence in patients with fully resected, lung metastatic osteosarcoma. These results will be compared against a newly developed, regulatorily compliant synthetic control group of case-matched patients, which will support the company's upcoming FDA Biologics License Application (BLA) for OST-HER2. Parallel submissions to international regulators are also planned to secure global marketing authorization.
• In January 2025, According to a press release reporting results from the Phase 2b clinical trial (NCT04974008), treatment with the investigational HER2-targeted immunotherapy OST-HER2 (OST31-164) demonstrated a statistically significant improvement in event-free survival (EFS) for preventing recurrence in patients with fully resected, lung-metastatic osteosarcoma.
• In January 2025, The FDA has granted Breakthrough Therapy Designation (BTD) to GSK'227, a B7-H3-targeted antibody-drug conjugate (ADC) under investigation for adult patients with relapsed/refractory osteosarcoma who have progressed after at least two prior therapies. This designation is based on findings from the Phase 2, open-label, randomized, multicenter ARTEMIS-002 study (NCT05830123), which assessed the safety and efficacy of GSK'227 in patients with relapsed/refractory osteosarcoma and other sarcomas. The trial included over 60 participants, with 42 diagnosed with osteosarcoma.
• In January 2025, OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company focused on immunotherapies and targeted drug conjugates for cancer, has announced positive results from its Phase 2b trial (NCT04974008) of OST-HER2 (OST31-164). This HER2-targeted immunotherapy is being developed for the prevention of recurrent, fully resected, lung metastatic osteosarcoma, a rare pediatric-designated indication. The study met its primary endpoint of 12-month event-free survival (EFS), showing a statistically significant improvement compared to historical controls. Additionally, interim 1-year and 2-year data indicate a strong trend favoring overall survival (OS) in OST-HER2-treated patients. Notably, all patients who met the 12-month EFS endpoint remain alive.
• In April 2024, Lisata Therapeutics received orphan drug designation from the FDA for its investigational agent LSTA1 (CEND-1) to treat pediatric and adult patients with osteosarcoma.

Osteosarcoma Overview
Osteosarcoma is the most common type of primary bone cancer that usually develops in the long bones, such as the arms and legs, particularly around the knee. It most often affects children, teenagers, and young adults. The cancer arises from immature bone-forming cells called osteoblasts, leading to the production of abnormal bone tissue. Symptoms typically include bone pain, swelling, and limited joint movement. While treatment often involves a combination of surgery and chemotherapy, early detection is crucial to improve outcomes and prevent the cancer from spreading, especially to the lungs.

Get a Free Sample PDF Report to know more about Osteosarcoma Pipeline Therapeutic Assessment-
https://www.delveinsight.com/report-store/osteosarcoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Emerging Osteosarcoma Drugs Under Different Phases of Clinical Development Include:
• Olaparib: Dana-Farber Cancer Institute
• Vactosertib: MedPacto, Inc.
• ZN-c3: K-Group, Beta, Inc.
• Nivolumab: H. Lee Moffitt Cancer Center
• HS-20093: Hansoh BioMedical R&D Company
• Cabozantinib: Ipsen
• cisplatin: UNICANCER
• Afamitresgene autoleucel: Adaptimmune
• Aldesleukin: M.D. Anderson Cancer Center

Osteosarcoma Route of Administration
Osteosarcoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Osteosarcoma Molecule Type
Osteosarcoma Products have been categorized under various Molecule types, such as
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Osteosarcoma Pipeline Therapeutics Assessment
• Osteosarcoma Assessment by Product Type
• Osteosarcoma By Stage and Product Type
• Osteosarcoma Assessment by Route of Administration
• Osteosarcoma By Stage and Route of Administration
• Osteosarcoma Assessment by Molecule Type
• Osteosarcoma by Stage and Molecule Type

DelveInsight's Osteosarcoma Report covers around 30+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Osteosarcoma product details are provided in the report. Download the Osteosarcoma pipeline report to learn more about the emerging Osteosarcoma therapies
https://www.delveinsight.com/sample-request/osteosarcoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key companies in the Osteosarcoma Therapeutics Market include:
Key companies developing therapies for Osteosarcoma are - Pfizer Inc., Recordati Group, Takeda Pharmaceutical Company, Amgen, Baxter, Bayer AG, Hikma Pharmaceuticals, Johnson & Johnson, Novartis AG, Debiopharm, Eli Lilly and Company, Atlanthera, Spectrum Pharmaceuticals Inc., and others.

Osteosarcoma Pipeline Analysis:
The Osteosarcoma pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Osteosarcoma with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Osteosarcoma Treatment.
• Osteosarcoma key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Osteosarcoma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Osteosarcoma market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Osteosarcoma drugs and therapies
https://www.delveinsight.com/sample-request/osteosarcoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Osteosarcoma Pipeline Market Strengths
• The rise in the incidence of osteosarcoma
• Improvement of treatment over the years along with newly updated guidelines
• Various immunotherapies such as PD-L1 inhibitors and CTLA4 inhibitors are under investigation for osteosarcoma

Osteosarcoma Pipeline Market Opportunities
• Genetic and other disease-related biomarkers are not much explored in drug development
• Lack of approved drugs for chemo-resistant disease and maintenance therapy

Scope of Osteosarcoma Pipeline Drug Insight
• Coverage: Global
• Key Osteosarcoma Companies: Dana-Farber Cancer Institute, MedPacto, Inc., K-Group, Beta, Inc., H. Lee Moffitt Cancer Center, Hansoh BioMedical R&D Company, Ipsen, UNICANCER, Adaptimmune, M.D. Anderson Cancer Center, and others
• Key Osteosarcoma Therapies: Olaparib, Vactosertib, ZN-c3, Nivolumab, HS-20093, Cabozantinib, cisplatin, Afamitresgene autoleucel, Aldesleukin, and others
• Osteosarcoma Therapeutic Assessment: Osteosarcoma current marketed and Osteosarcoma emerging therapies
• Osteosarcoma Market Dynamics: Osteosarcoma market drivers and Osteosarcoma market barriers

Contact Us:
Gaurav Bora
gbora@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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