Ewing Sarcoma Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Ewing Sarcoma Pipeline Insights" report provides comprehensive insights about 25+ Ewing Sarcoma companies and 25+ pipeline drugs in the Ewing Sarcoma pipeline landscape. It covers the Ewing Sarcoma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Ewing Sarcoma pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Ewing Sarcoma Pipeline Report

* In February 2025:- Sarcoma Oncology Research Center :- The primary objective is to evaluate the efficacy of SM-88, a combination metabolic cancer treatment, measured as positive efficacy events, including overall response, maintaining stable disease for greater than or equal to 3 months, or progression free survival at least 1.5 times longer than the last prior line of treatment.
* In February 2025:- Eli Lilly and Company :- The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolamide) for Ewing's sarcoma that has come back or did not respond to treatment. This trial is part of the CAMPFIRE master protocol, which is a platform to speed development of new treatments for children and young adults with cancer. Your participation in this trial could last 11 months or longer, depending on how you and your tumor respond.
* In February 2025:- Merck Sharp & Dohme LLC :- Substudy 01A is part of a platform study. The purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL)/Burkitt lymphoma, or neuroblastoma and in pediatric and young adult participants with Ewing sarcoma.
* DelveInsight's Ewing Sarcoma pipeline report depicts a robust space with 25+ Ewing Sarcoma companies working to develop 25+ pipeline therapies for Ewing Sarcoma treatment.
* The leading Ewing Sarcoma Companies such as Gradalis, Inc., Shanghai Pharmaceuticals Holding Co., Ltd, Tyme, Inc, Pfizer, Hutchison Medipharma Limited, Bristol-Myers Squibb, Salarius Pharmaceuticals, BioAtla, Inc., Cellectar Biosciences, Valent Technologies, Inhibrx, Inc., Eisai Co Ltd, Amgen, Y-mAbs Therapeutics, NanoValent Pharmaceuticals, Oncternal Therapeutics, Aptadel Therapeutics, Gibson Oncology, Edison Oncology, Oncoheroes Biosciences, CotheraBio, Rakovina Therapeutics , and others.
* Promising Ewing Sarcoma Pipeline Therapies such as Vigil, Temozolomide, Irinotecan, CP-751,871, Eribulin mesylate, Combination metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus (MPS), TB-403 20mg/kg, Irinotecan, Temozolomide, exatecan mesylate, CP-751,871, plerixafor , and others.

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Ewing Sarcoma Emerging Drugs

* Vigil: Gradalis

Gradalis is developing and testing Vigil, a fully personalized, patient-specific cancer immunotherapy that can be applied to virtually any cancer. Vigil utilizes the patient's own cancer cells to create a fully personalized cancer immunotherapy with the goal to activate the patient's own T-cells against their cancer cells. When those cells are reintroduced back into the patient, the two modifications are designed to help activate the immune system to detect and kill any cancer cells that may remain locally and in circulation. All together, the goal is to stimulate the existing components of the immune system with the intent to improve their anti-tumor responses. Vigil enhances specific functions that assist in cancer antigen recognition and dampen other functions that cancer cells often employ to evade the immune system. A Phase III clinical trial of Vigil in combination with irinotecan and temozolomide for the treatment of patients with Ewing's sarcoma (EWS) is currently ongoing.

* ONCT216: Oncternal Therapeutics

ONCT-216 (formerly called TK216) is a first-in-class small molecule inhibiting the biological activity of ETS-family (E26 Transformation Specific) transcription factor oncoproteins in a variety of tumor types. It is currently being evaluated in the Phase II portion of a study in patients with relapsed or refractory Ewing sarcoma, a serious pediatric bone cancer. ONCT-216 was developed based on the discoveries of Jeff Toretsky, MD, at Georgetown University, who identified a small molecule that was shown to kill Ewing sarcoma cells and inhibit growth of tumors in preclinical studies. Oncternal scientists developed and tested a large series of derivatives of the research molecule and after extensive evaluation, ONCT-216 was selected as a lead product candidate. ONCT-216 has been extensively evaluated in preclinical studies, where it has been confirmed to kill Ewing sarcoma cells and inhibit Ewing sarcoma tumors in animal models. The company continues to collaborate with Dr. Toretsky and his colleagues in order to advance the research underlying the molecular pathways of ONCT-216 and optimize its development across multiple tumor types.

* SP-2577: Salarius Pharmaceuticals

SP-2577 is being studied in an ongoing Phase I/II trial treating three different patient groups with sarcomas, including Ewing Sarcoma, Myxoid Liposarcoma and additional FET-rearranged soft tissue sarcomas. These are cancers with high-unmet need and represent Salarius' "speed-to-market strategy" given the potential for accelerated approval. Salarius' LSD1 technology was licensed from the University of Utah Huntsman Cancer Institute where it was developed in the laboratory of Dr. Sunil Sharma.

The Ewing Sarcoma pipeline report provides insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Ewing Sarcoma 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 Ewing Sarcoma Treatment.
* Ewing Sarcoma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Ewing Sarcoma 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 Ewing Sarcoma market.

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Ewing Sarcoma Companies

Gradalis, Inc., Shanghai Pharmaceuticals Holding Co., Ltd, Tyme, Inc, Pfizer, Hutchison Medipharma Limited, Bristol-Myers Squibb, Salarius Pharmaceuticals, BioAtla, Inc., Cellectar Biosciences, Valent Technologies, Inhibrx, Inc., Eisai Co Ltd, Amgen, Y-mAbs Therapeutics, NanoValent Pharmaceuticals, Oncternal Therapeutics, Aptadel Therapeutics, Gibson Oncology, Edison Oncology, Oncoheroes Biosciences, CotheraBio, Rakovina Therapeutics, and others.

Ewing Sarcoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

* Inhalation
* Inhalation/Intravenous/Oral
* Intranasal
* Intravenous
* Intravenous/ Subcutaneous
* NA
* Oral
* Oral/intranasal/subcutaneous
* Parenteral
* Subcutaneous

Ewing Sarcoma Products have been categorized under various Molecule types such as

* Antibody
* Antisense oligonucleotides
* Immunotherapy
* Monoclonal antibody
* Peptides
* Protein
* Recombinant protein
* Small molecule
* Stem Cell
* Vaccine

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Scope of the Ewing Sarcoma Pipeline Report

* Coverage- Global
* Ewing Sarcoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Ewing Sarcoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
* Ewing Sarcoma Companies- Gradalis, Inc., Shanghai Pharmaceuticals Holding Co., Ltd, Tyme, Inc, Pfizer, Hutchison Medipharma Limited, Bristol-Myers Squibb, Salarius Pharmaceuticals, BioAtla, Inc., Cellectar Biosciences, Valent Technologies, Inhibrx, Inc., Eisai Co Ltd, Amgen, Y-mAbs Therapeutics, NanoValent Pharmaceuticals, Oncternal Therapeutics, Aptadel Therapeutics, Gibson Oncology, Edison Oncology, Oncoheroes Biosciences, CotheraBio, Rakovina Therapeutics , and others.
* Ewing Sarcoma Pipeline Therapies- Vigil, Temozolomide, Irinotecan, CP-751,871, Eribulin mesylate, Combination metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus (MPS), TB-403 20mg/kg, Irinotecan, Temozolomide, exatecan mesylate, CP-751,871, plerixafor , and others.

Which companies are leading the race in Ewing Sarcoma drug development? Find out in DelveInsight's exclusive Ewing Sarcoma Pipeline Report-access it now! @ Ewing Sarcoma Emerging Drugs and Major Companies [https://www.delveinsight.com/sample-request/ewing-sarcoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Table of Content

* Introduction
* Ewing Sarcoma Executive Summary
* Ewing Sarcoma: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Ewing Sarcoma - DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Vigil: Gradalis
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* ONCT216: Oncternal Therapeutics
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I/II)
* SP-2577: Salarius Pharmaceuticals
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* CLR 131: Cellectar Biosciences
* Drug profiles in the detailed report.....
* Inactive Products
* Ewing Sarcoma Companies
* Ewing Sarcoma Key Products
* Ewing Sarcoma Unmet Needs
* Ewing Sarcoma Market Drivers and Barriers
* Ewing Sarcoma Future Perspectives and Conclusion
* Ewing Sarcoma Analyst Views
* Ewing Sarcoma Key Companies
* Appendix

About Us

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