Neuroblastoma Pipeline Insight and Clinical Trials Analysis and NDA Approvals | 35+ Companies and 35+ Drugs

DelveInsight’s, “Neuroblastoma Pipeline Insight, 2023,” report provides comprehensive insights about 35+ Neuroblastoma companies and 35+ pipeline drugs in Neuroblastoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. Neuroblastoma pipeline report also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. 

In the Neuroblastoma pipeline report, a detailed description of the drug is given which includes the mechanism of action of the drug, clinical studies, Neuroblastoma NDA approvals (if any), and product development activities comprising the technology, Neuroblastoma collaborations, licensing, mergers and acquisition, funding, designations and other product-related details.

Key Takeaways from the Neuroblastoma Pipeline Report

• DelveInsight’s neuroblastoma pipeline report depicts a robust space with 35+ active players working to develop 35+ pipeline therapies for neuroblastoma treatment.
• The leading Neuroblastoma companies such as Clarity Pharmaceuticals Ltd, Eli Lilly and Company, Laboratorio Elea Phoenix S.A., PersonGen BioTherapeutics (Suzhou) Co., Ltd., Advanced Accelerator Applications, K C Pharmaceuticals Inc., Curis, Inc., Pfizer, Valent Technologies, LLC, UGISense AG, Y-mAbs Therapeutics, Ascentage Pharma, Kuur Therapeutics, Cell Medica, Autolus, NanoPharmaceuticals, Aptorum Group, and others.
• Promising Neuroblastoma pipeline therapies in various stages of development include 67Cu-SARTATE, LY3295668,  Racotumomab, TAA06, Iobenguane I-131, 177Lu-DOTATATE, Eflornithine, CUDC-907, Lorlatinib, VAL-413, Ugimers, Omburtamab, Alrizomadlin, KUR-501, Nivatrotamab, CMD-501, DFMO, AUTO6, BG-P-TAT, SACT 1, and others.
• The Neuroblastoma companies and academics are working to assess challenges and seek opportunities that could influence Neuroblastoma R&D. The Neuroblastoma pipeline therapies under development are focused on novel approaches to treat/improve Neuroblastoma.

To explore more information on the latest breakthroughs in the Neuroblastoma Pipeline treatment landscape of the report, click here @ Neuroblastoma Pipeline Outlook 

Neuroblastoma Overview

Neuroblastoma is a highly malignant tumor in infants. However, it may also occur in children under 5 years of age. Neuroblastoma is composed of neuroblasts, usually in the medulla of an adrenal gland. However, it is possible for the tumor to form in the nerve tissue of the spinal cord, chest, or neck. According to the National Cancer Institute, neuroblastoma is the first most common cancer in infants, and the third most common cancer in children. > 600 cases are diagnosed annually in the United States. It accounts for approximately 15% of all pediatric cancer fatalities. Incidence is higher in non-African-American children, and it is slightly more common in males than females. Neuroblastoma sometimes forms before birth and may be discovered during a fetal ultrasound.

Recent Developmental Activities in the Neuroblastoma Treatment Landscape

• In July 2022, PersonGen Biotherapeutics announced that the Center for Drug Evaluation (CDE) of NMPA had cleared the company’s Investigational New Drug (IND) application for TAA06, an engineered autologous cell therapy targeting B7-H3 for the treatment of R/R Neuroblastoma.
• In February 2022, Clarity Pharmaceuticals announced that it had completed cohort 1 and advanced to cohort 2 in the 64Cu/67Cu SARTATE Neuroblastoma trial (CL04 trial).
• In March 2022, Ascentage Pharma announced that its novel MDM2-p53 inhibitor, alrizomadlin (APG-115), was granted a Rare Pediatric Disease (RPD) designation by the US Food and Drug Administration (FDA) for the treatment of neuroblastoma.
• In May 2022, Aptorum Group Limited announced the finalized data from the Phase 1 clinical trial of SACT-1, a repurposed small molecule drug targeting Neuroblastoma and potentially other cancer types. The study treatments were well tolerated, and no subjects were discontinued from study participation because of adverse events. No serious adverse events were reported during the study. The phase 1 clinical data also suggested that any QT interval after oral administration of SACT-1 at 150mg was well within clinically acceptable limits.
• In January 2021, Kuur Therapeutics announced clinical updates for both the phase 1 GINAKIT2 study of KUR-501 (autologous GD2 CAR-NKT cells) being tested in patients with relapsed/refractory (R/R) neuroblastoma and the phase 1 ANCHOR study of KUR-502 (off-the-shelf CD19 CAR-NKT cells) being evaluated in patients with R/R CD19 positive malignancies. Complete responses and evidence of tumor homing have been observed in both trials, and the CAR-NKT cell therapy has been safe and well-tolerated.

Request a sample and discover the recent advances in Neuroblastoma Ongoing Clinical Trial Analysis and Medications, click here @ Neuroblastoma Treatment Landscape

Emerging Neuroblastoma Drugs Profile  

• 67Cu MeCOSar Octreotate  : Clarity Pharmaceuticals

SARTATE is a next generation, highly targeted theranostic radiopharmaceutical with increased specificity and in-vivo stability, being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2). 67Cu SARTATE Peptide Receptor Radionuclide Therapy (PRRT) is being administered to Pediatric Patients with High-Risk Neuroblastoma (CL04). 7Cu SARTATE and 64Cu SARTATE have been granted FDA Orphan Drug Designation (ODD) status for the treatment and clinical management of neuroblastoma. 

• Isotretinoin : Nova Laboratories

13-CRA is one of several stereoisomers of retinoic acid, the main biologically active derivative of vitamin A, and has been used as a cancer chemopreventive agent due to its ability to induce cell differentiation, inhibit proliferation and induce apoptosis. 13-cis-retinoic acid (13-CRA) is a key component of neuroblastoma treatment protocols. To overcome the challenge of dosing accuracy and palatability and to minimize the teratogenic risk for women of childbearing potential with the current method of manipulation of capsule, a convenient, ready-to-use, multi-dose, oral liquid formulation of 13-CRA has been developed. 

• AK 01 : Eli Lilly and Company

AurKa Pharma’s asset, AK-01, has been shown to be highly selective for Aurora A, with potential clinical benefit observed in Phase 1 studies. Future studies will seek to determine if the selectivity profile of AK-01 can improve efficacy while limiting toxicity risks to a manageable level.

Neuroblastoma Pipeline Therapeutics Assessment

There are approx. 35+ key companies which are developing the therapies for Neuroblastoma. The Neuroblastoma companies which have their Neuroblastoma drug candidates in the most advanced stage, i.e. Phase I/II, Clarity Pharmaceuticals.

For further information, refer to the detailed Neuroblastoma Unmet Needs, Neuroblastoma Market Drivers, and Market Barriers, click here for Neuroblastoma Ongoing Clinical Trial Analysis

Scope of the Neuroblastoma Pipeline Report

• Coverage- Global
• Neuroblastoma Companies- Clarity Pharmaceuticals Ltd, Eli Lilly and Company, Laboratorio Elea Phoenix S.A., PersonGen BioTherapeutics (Suzhou) Co., Ltd., Advanced Accelerator Applications, K C Pharmaceuticals Inc., Curis, Inc., Pfizer, Valent Technologies, LLC, UGISense AG, Y-mAbs Therapeutics, Ascentage Pharma, Kuur Therapeutics, Cell Medica, Autolus, NanoPharmaceuticals, Aptorum Group, and others.
• Neuroblastoma Pipeline Therapies- 67Cu-SARTATE, LY3295668,  Racotumomab, TAA06, Iobenguane I-131, 177Lu-DOTATATE, Eflornithine, CUDC-907, Lorlatinib, VAL-413, Ugimers, Omburtamab, Alrizomadlin, KUR-501, Nivatrotamab, CMD-501, DFMO, AUTO6, BG-P-TAT, SACT 1, and others.
• Neuroblastoma Pipeline Segmentation: Product Type, Molecule Type, Mechanism of action, Route of Action

Dive deep into rich insights for drugs for Neuroblastoma Market Drivers and Neuroblastoma Market Barriers, click here @ Neuroblastoma Unmet Needs and Analyst Views 

Table of Content

1. Introduction
2. Executive Summary
3. Neuroblastoma: Overview
4. Neuroblastoma Pipeline Therapeutics
5. Neuroblastoma Therapeutic Assessment
6. Neuroblastoma– DelveInsight’s Analytical Perspective
7. Late Stage Neuroblastoma Products (Pre-Registration)
8. Drug Name : Company Name
9. Drug profiles in the detailed report…..
10. End Stage Neuroblastoma Products (Phase III)
11. Drug Name : Company Name
12. Drug profiles in the detailed report…..
13. Mid Stage Neuroblastoma Products (Phase I/ II)
14. Isotretinoin : Nova Laboratories
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. Drug Name : Company Name
18. Drug profiles in the detailed report…..
19. Inactive Neuroblastoma Products
20. Neuroblastoma Key Companies
21. Neuroblastoma Key Products
22. Neuroblastoma- Unmet Needs
23. Neuroblastoma- Market Drivers and Barriers
24. Neuroblastoma- Future Perspectives and Conclusion
25. Neuroblastoma Analyst Views
26. Neuroblastoma Key Companies
27. Appendix

Got Queries? Find out the related information on Neuroblastoma Mergers and acquisitions, Neuroblastoma licensing activities @ Neuroblastoma Emerging Drugs, and Recent Trends

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