Metastatic Melanoma Pipeline and Therapies 2024: FDA Approvals, Clinical Trials, Therapies, Mechanism of Action, Route of Administration by DelveInsight | TILT Bio, AiVita Biomedical

Metastatic Melanoma Pipeline and Therapies 2024: FDA Approvals, Clinical Trials, Therapies, Mechanism of Action, Route of Administration by DelveInsight | TILT Bio, AiVita Biomedical
Metastatic Melanoma Pipeline

As per DelveInsight’s assessment, globally, Metastatic Melanoma pipeline constitutes 75+ key companies continuously working towards developing 75+ Metastatic Melanoma treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Metastatic Melanoma 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.


Metastatic Melanoma Pipeline Insight 2024 report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Metastatic Melanoma Market.


Some of the key takeaways from the Metastatic Melanoma Pipeline Report:

  • Metastatic Melanoma Companies across the globe are diligently working toward developing novel Metastatic Melanoma treatment therapies with a considerable amount of success over the years. 
  • Metastatic Melanoma companies working in the treatment market are TILT Biotherapeutics, AiVita Biomedical, Immuneering Corporation, Ultimovacs ASA, MPyxis Oncology, Evaxion Biotech, HUYABIO International, LLC., IO Biotech, Regeneron Pharmaceuticals, and others, are developing therapies for the Metastatic Melanoma treatment 
  • Emerging Metastatic Melanoma therapies in the different phases of clinical trials are- TILT 123, AV-MEL-1, IMM-1-104, UV1, APX005, EVX 01, HBI-8000, IO102-IO103, Fianlimab, and others are expected to have a significant impact on the Metastatic Melanoma market in the coming years.   
  • In July 2022, “A Phase III Trial of Fianlimab(REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma” is the name of the trial that Regeneron Pharmaceuticals started.
  • In July 2022, The US FDA has approved an investigational new drug application for OBX-115, Obsidian’s main engineered tumor infiltrating lymphocyte (TIL) treatment candidate, to be studied in a Phase I clinical study sponsored by MD Anderson. Obsidian Therapeutics, Inc. made this announcement. OBX-115 is the result of an arrangement announced in 2020 that was created in partnership with MD Anderson. The intended single-arm, open-label, first-in-human Phase I research will assess the safety and initial effectiveness of OBX-115 as a monotherapy in adult patients with metastatic melanoma who have relapsed or are not responding to previous anti-PD-1 antibody-containing treatment regimens.
  • In July 2022, According to a statement released by Bristol Myers Squibb, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has suggested that the fixed-dose combination of relatlimab and nivolumab be approved 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 CHMP opinion will now be reviewed by the European Commission (EC), which has the power to approve medications for the European Union (EU).
  • In late July 2022, Iovance successfully had a pre-BLA meeting with the US FDA. Regarding the potency assay matrix and follow-up time for the clinical efficacy data from Cohorts 2 and 4 of the C-144-01 clinical study, the FDA gave positive response. The clinical and safety dataset was deemed adequate by the FDA for BLA assessment. This month, Iovance will start a rolling BLA filing for lifileucel in metastatic melanoma; the submission will be finished in the fourth quarter.
  • In June 2022, Sanofi and Immunocore Holdings Plc signed a clinical trial cooperation and supply agreement. As per the agreement, as part of Sanofi’s ongoing Phase I/II study, the company will assess its precisely PEGylated, engineered version of IL-2, SAR444245, in combination with Immunocore’s novel bispecific protein targeting gp100, known as KIMMTRAK, in patients with HLA-A*02:01 positive advanced unresectable or metastatic skin cancers.
  • In March 2022, After PD-1 inhibitor treatment failed, the US FDA awarded Fast Track designation to 7HP349. This is the primary clinical-stage immunostimulant from 7Hill Pharma, and it is intended to be used in conjunction with a CTLA-4 inhibitor to treat patients with metastatic or unresectable malignant melanoma.
  • In March 2022, The FDA authorized the use of Opdualag (nivolumab and relatlimab-rmbw) by the Bristol-Myers Squibb Company in patients with metastatic or incurable melanoma who are 12 years of age or older in adults and pediatric patients. The medication is a fixed-dose combination of nivolumab, an antibody that blocks programmed death receptor-1, and relatlimab, an antibody that blocks LAG-3.
  • In January 2022, Immunocore reported that KIMMTRAK (tebentafusp-tebn) has been approved by the US Food and Drug Administration to treat adult patients with unresectable or metastatic uveal melanoma (mUM) who test positive for HLA-A*02:01. In February 2021, the FDA gave KIMMTRAK Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma.Four weeks before the designated PDUFA date of February 23, 2022, the approval was given.


Metastatic Melanoma Overview

There are numerous medications in the Metastatic Melanoma pipeline at the moment. Among the most prominent medications for this indication are TILT 123, AV-MEL-1, IMM-1-104, UV1, APX005, EVX 01, HBI-8000, IO102-IO103, Fianlimab, and a few more. Current clinical studies and ongoing research could alter the industry.


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Emerging Metastatic Melanoma Drugs Under Different Phases of Clinical Development Include:

  • TILT 123: TILT Biotherapeutics
  • AV-MEL-1: AiVita Biomedical
  • IMM-1-104: Immuneering Corporation
  • UV1: Ultimovacs ASA
  • APX005: MPyxis Oncology
  • EVX 01: Evaxion Biotech
  • HBI-8000: HUYABIO International, LLC.
  • IO102-IO103: IO Biotech
  • Fianlimab: Regeneron Pharmaceuticals


Metastatic Melanoma Route of Administration

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

  • Intra-articular
  • Intraocular
  • Intrathecal
  • Intravenous
  • Ophthalmic
  • Oral
  • Parenteral
  • Subcutaneous
  • Topical
  • Transdermal


Metastatic Melanoma Molecule Type

Metastatic Melanoma Products have been categorized under various Molecule types, such as

  • Oligonucleotide
  • Peptide
  • Small molecule


Metastatic Melanoma Pipeline Therapeutics Assessment

  • Metastatic Melanoma Assessment by Product Type
  • Metastatic Melanoma By Stage and Product Type
  • Metastatic Melanoma Assessment by Route of Administration
  • Metastatic Melanoma By Stage and Route of Administration
  • Metastatic Melanoma Assessment by Molecule Type
  • Metastatic Melanoma by Stage and Molecule Type


DelveInsight’s Metastatic Melanoma Report covers around 75+ 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 Metastatic Melanoma product details are provided in the report. Download the Metastatic Melanoma pipeline report to learn more about the emerging Metastatic Melanoma therapies


Some of the key companies in the Metastatic Melanoma Therapeutics Market include:

Key companies developing therapies for Metastatic Melanoma are – Evaxion Biotech, InxMed, AiVita Biomedical, Iovance Biotherapeutics, Viralytics, Merck & Co., Neon Therapeutics, BioNTech, Bristol-Myers Squibb, Ono Pharmaceuticals, Cytovation AS, Biocad, Apexigen, Checkmate Pharmaceutical, Nektar therapeutics, HUYABIO International, LLC.,  IO Biotech,  Bristol Myers Squibb, Karyopharm Therapeutics, Zucero Therapeutics, GlaxoSmithKline,  Tesaro, Inc., Ultimovacs ASA, Eucure (Beijing) Biopharma Co., Ltd, Incyte Corporation, Philogen S.p.A., Ascentage Pharma, Exelixis/Ipsen, NovoCure Ltd., Hoffman-La-Roche, Provectus Biopharmaceuticals, BerGenBio ASA, Idera Pharmaceuticals, Celgene Corporation, Novartis, and others.


Metastatic Melanoma Pipeline Analysis:

The Metastatic Melanoma pipeline report provides insights into 

  • The report provides detailed insights about companies that are developing therapies for the treatment of Metastatic Melanoma 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 Metastatic Melanoma Treatment.
  • Metastatic Melanoma key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Metastatic Melanoma 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 Metastatic Melanoma 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 Metastatic Melanoma drugs and therapies


Metastatic Melanoma Pipeline Market Drivers

Improving Healthcare Infrastructure, emergence of effective immune therapies are some of the important factors that are fueling the Metastatic Melanoma Market.


Metastatic Melanoma Pipeline Market Barriers

However, lack of cost-effective treatment, side effects associated with the treatment and other factors are creating obstacles in the Metastatic Melanoma Market growth.


Scope of Metastatic Melanoma Pipeline Drug Insight    

  • Coverage: Global
  • Key Metastatic Melanoma Companies: TILT Biotherapeutics, AiVita Biomedical, Immuneering Corporation, Ultimovacs ASA, MPyxis Oncology, Evaxion Biotech, HUYABIO International, LLC., IO Biotech, Regeneron Pharmaceuticals, and others
  • Key Metastatic Melanoma Therapies: TILT 123, AV-MEL-1, IMM-1-104, UV1, APX005, EVX 01, HBI-8000, IO102-IO103, Fianlimab, and others
  • Metastatic Melanoma Therapeutic Assessment: Metastatic Melanoma current marketed and Metastatic Melanoma emerging therapies
  • Metastatic Melanoma Market Dynamics: Metastatic Melanoma market drivers and Metastatic Melanoma market barriers 


Request for Sample PDF Report for Metastatic Melanoma Pipeline Assessment and clinical trials


Table of Contents

1. Metastatic Melanoma Report Introduction

2. Metastatic Melanoma Executive Summary

3. Metastatic Melanoma Overview

4. Metastatic Melanoma- Analytical Perspective In-depth Commercial Assessment

5. Metastatic Melanoma Pipeline Therapeutics

6. Metastatic Melanoma Late Stage Products (Phase II/III)

7. Metastatic Melanoma Mid Stage Products (Phase II)

8. Metastatic Melanoma Early Stage Products (Phase I)

9. Metastatic Melanoma Preclinical Stage Products

10. Metastatic Melanoma Therapeutics Assessment

11. Metastatic Melanoma Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Metastatic Melanoma Key Companies

14. Metastatic Melanoma Key Products

15. Metastatic Melanoma Unmet Needs

16 . Metastatic Melanoma Market Drivers and Barriers

17. Metastatic Melanoma Future Perspectives and Conclusion

18. Metastatic Melanoma Analyst Views

19. Appendix

20. About DelveInsight


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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