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Metastatic Melanoma Pipeline, Clinical Trials Analysis and NDA Approvals | 75+ Companies and 75+ Drugs

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Metastatic Melanoma Pipeline, Clinical Trials Analysis and NDA Approvals | 75+ Companies and 75+ Drugs

January 23
16:50 2023
Metastatic Melanoma Pipeline, Clinical Trials Analysis and NDA Approvals | 75+ Companies and 75+ Drugs

DelveInsight’s, “Metastatic Melanoma Pipeline Insight, 2023” report provides comprehensive insights about 75+ companies and 75+ pipeline drugs in Metastatic Melanoma pipeline landscape. It covers the Metastatic Melanoma pipeline drug profiles, including Metastatic Melanoma clinical trial and nonclinical stage products. It also covers the Metastatic Melanoma pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

 

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

 

Key takeaways from the Metastatic Melanoma Pipeline Report

  • DelveInsight’s metastatic melanoma pipeline report depicts a robust space with 75+ active players working to develop 75+ pipeline therapies for metastatic melanoma treatment.
  • The leading Metastatic Melanoma Companies include Evaxion Biotech, InxMed, AiVita Biomedical, Iovance Biotherapeutics, Viralytics, Merck & Co., Neon Therapeutics, BioNTech, Bristol-Myers Squibb, Ono Pharmaceuticals, Cytovation AS, and others.
  • Promising Metastatic Melanoma Pipeline Therapies includes EVX 01, IN 10018, AV MEL 1, Lifileucel, V937, NEO-PTC-01, Relatlimab, CyPep-1, HBI-8000, NKTR-214,CMP-001, IO102-IO103,  EVX-01, APX005M, BCD-217, Dostarlimab, LXH254, Niraparib, BNT111, UV1, YH003, Retifanlimab,  L19IL2+L19TNF, Pexa-Vec, APG-115, Cabozantinib, RO7247669, PV-10, BGB324, VB10.NEO, IMO-2125, ABI-007, HX008, BVD-523, IOV-4001, ST101, BGB-10188, DYP688, ATL001, PAC-1, IN10018, SX-682, TILT-123, PV-001-DC, CDX-301, TBX-3400, GR-MD-02, FHD-286, SD-101, MB-CART20.1, BMS-986249, SEA-CD40, LAG525, Fianlimab, ADP-TILIL7, Poke-101, and others.
  • The Metastatic Melanoma Companies and academics are working to assess challenges and seek opportunities that could influence Metastatic Melanoma R&D. The Metastatic Melanoma pipeline therapies under development are focused on novel approaches to treat/improve Metastatic Melanoma.

 

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

 

Recent Developmental Activities in the Metastatic Melanoma Treatment Landscape

  • In July 2022, Obsidian Therapeutics, Inc. announced that the US FDA cleared an Investigational New Drug application for an MD Anderson-sponsored Phase I clinical study of OBX-115, Obsidian’s lead engineered tumor infiltrating lymphocyte (TIL) therapy candidate. OBX-115 has been developed in collaboration with MD Anderson as part of an agreement announced in 2020. The planned first-in-human single-arm, open-label, Phase I study will evaluate the safety and preliminary efficacy of OBX-115 as monotherapy in adult patients with metastatic melanoma who are relapsed or refractory to prior therapeutic regimens containing anti-PD-1 antibodies.
  • In July 2022Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the fixed-dose combination of nivolumab and relatlimab for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1%. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP opinion.
  • Iovance held a successful pre-BLA meeting with the US FDA in late July 2022. The FDA provided favorable feedback on the clinical efficacy data from Cohorts 2 and 4 of the C-144-01 clinical trial, including duration of follow up, and the potency assay matrix. The FDA agreed the clinical and safety dataset was sufficient for BLA review. Iovance will commence a rolling BLA submission for lifileucel in metastatic melanoma this month and complete the submission during the fourth quarter.
  • In June 2022Immunocore Holdings Plc entered into a clinical trial collaboration and supply agreement with Sanofi. Under the agreement, Sanofi will evaluate its precisely PEGylated, engineered version of IL-2, SAR444245, in combination with KIMMTRAK, Immunocore’s novel bispecific protein targeting gp100, in HLA-A*02:01 positive patients with advanced unresectable or metastatic skin cancers as part of Sanofi’s ongoing Phase I/II study.
  • In March 2022, US FDA granted Fast Track designation to 7HP349, 7Hill Pharma’s lead clinical-stage immunostimulant, in combination with a CTLA-4 inhibitor for the treatment of patients with unresectable or metastatic malignant melanoma following treatment failure with a PD-1 inhibitor.
  • In March 2022, FDA approved Bristol-Myers Squibb Company’s Opdualag (nivolumab and relatlimab-rmbw) for use in adults and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. The drug is a fixed-dose combination of the LAG-3-blocking antibody relatlimab and the programmed death receptor-1 blocking antibody nivolumab.
  • In January 2022Immunocore announced approval from the United States Food and Drug Administration of KIMMTRAK (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK was granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma by the FDA in February 2021.The approval was granted four weeks ahead of the assigned PDUFA date of February 23, 2022.

 

Metastatic Melanoma Overview

Melanoma is the third most common cutaneous malignancy after basal cell carcinoma and squamous cell carcinoma. Melanoma is the fifth most common malignancy in males and sixth most common malignancy in females. Metastatic melanoma is a disease that occurs when the cancerous cells from the original tumor (primary tumor) get loose, spread by traveling through the lymph or blood circulation, and start a new tumor (metastatic tumor) somewhere else. Once it spreads, or metastasizes, the disease is known as metastatic melanoma. This type of melanoma may typically occur during stage 3 or stage 4. Common melanoma metastasis sites include the lymph nodes, lungs, liver, bones and brain. Metastatic melanoma symptoms and signs may include: Fatigue, swollen or painful lymph nodes, weight loss, loss of appetite, trouble breathing or a cough that doesn’t go away, bone pain, headaches, seizures, swelling of the liver.

 

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

 

Metastatic Melanoma Emerging Drugs Profile

 

EVX 01: Evaxion Biotech

EVX-01, is a novel personalized cancer immunotherapy based on Evaxion’s proprietary PIONEER™ AI technology. EVX-01 is safe and has encouraging early indications of clinically and meaningful antitumor activity. Data showed EVX-01 is capable of eliciting T-cell responses in a clinical setting where the patients received concurrent standard immune therapy, i.e. anti-PD-1 treatment. Results demonstrated an antitumor effect in combination with anti-PD-1 treatment. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Metastatic Melanoma.

 

IN 10018: InxMed

IN10018 is a potent and highly selective adenosine triphosphate competitive FAK inhibitor, and InxMed has its exclusive global development and commercial operation rights. Early clinical data on IN10018 showed its safety and efficacy in multiple tumor types, and the latest research results and preclinical data demonstrated that IN10018 can also be effective in combination therapies. It is expected to overcome the tumor-associated fibrosis barrier and improve local immunity, and therefore has the potential to act as an important anchor molecule in synergy with different therapeutic modalities including immunotherapy, chemotherapy, and targeted therapy. Currently, the drug is in Phase I stage of Clinical trial evaluation for the treatment of Metastatic Melanoma.

 

AV MEL 1: AiVita Biomedical

AV MEL 1, is an investigational drug being developed by AiVita Biomedical. AIVITA has received IND approval to begin a Phase 1B trial investigating its cancer vaccine in patients with metastatic melanoma plus checkpoint inhibitors.

 

Metastatic Melanoma Pipeline Therapeutics Assessment

There are approx. 75+ key companies which are developing the therapies for Metastatic Melanoma. The companies which have their Metastatic Melanoma drug candidates in the most advanced stage, i.e. Phase II, Evaxion Biotech.

 

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

 

Scope of the Metastatic Melanoma Pipeline Report

  • Coverage- Global
  • Metastatic Melanoma Companies- Evaxion Biotech, InxMed, AiVita Biomedical, Iovance Biotherapeutics, Viralytics, Merck & Co., Neon Therapeutics, BioNTech, Bristol-Myers Squibb, Ono Pharmaceuticals, Cytovation AS, and others.
  • Metastatic Melanoma Pipeline Therapies- EVX 01, IN 10018, AV MEL 1, Lifileucel, V937, NEO-PTC-01, Relatlimab, CyPep-1, HBI-8000, NKTR-214,CMP-001, IO102-IO103,  EVX-01, APX005M, BCD-217, Dostarlimab, LXH254, Niraparib, BNT111, UV1, YH003, Retifanlimab,  L19IL2+L19TNF, Pexa-Vec, APG-115, Cabozantinib, RO7247669, PV-10, BGB324, VB10.NEO, IMO-2125, ABI-007, HX008, BVD-523, IOV-4001, ST101, BGB-10188, DYP688, ATL001, PAC-1, IN10018, SX-682, TILT-123, PV-001-DC, CDX-301, TBX-3400, GR-MD-02, FHD-286, SD-101, MB-CART20.1, BMS-986249, SEA-CD40, LAG525, Fianlimab, ADP-TILIL7, Poke-101, and others.
  • Metastatic Melanoma Pipeline Segmentation: Phases, Product Type, Molecule Type, Route of administration, Mechanism of action

 

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

 

Table of Content

  1. Introduction
  2. Metastatic Melanoma Executive Summary
  3. Metastatic Melanoma: Overview
  4. Metastatic Melanoma Pipeline Therapeutics
  5. Metastatic Melanoma Therapeutic Assessment
  6. Metastatic Melanoma– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Drug name : Company name
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. EVX 01: Evaxion Biotech
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. IN 10018: InxMed
  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 Products
  20. Metastatic Melanoma Key Companies
  21. Metastatic Melanoma Key Products
  22. Metastatic Melanoma- Unmet Needs
  23. Metastatic Melanoma- Market Drivers and Barriers
  24. Metastatic Melanoma- Future Perspectives and Conclusion
  25. Metastatic Melanoma Analyst Views
  26. Metastatic Melanoma Key Companies
  27. Appendix

 

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

 

 

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