Melanoma Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, and Companies

DelveInsight's "Melanoma Pipeline Insights 2025" report provides comprehensive insights about 150+ companies and 170+ pipeline drugs in the Melanoma Pipeline landscape. It covers the Melanoma Pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Melanoma 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 Melanoma Pipeline Report

* On 24 August 2025, Bristol-Myers Squibb announced a study designed to demonstrate that the drug exposure level of the subcutaneous (SC) formulation of nivolumab + relatlimab fixed-dose combination (FDC) is not inferior to that of the intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.
* On 20 August 2025, the Grupo Espanol Multidisciplinar de Melanoma reported that the combination of enfortumab vedotin (EV) and pembrolizumab has shown a synergistic effect across various solid tumors. The combination of enfortumab vedotin and pembrolizumab may provide a dual impact on clinical outcomes.
* DelveInsight's Melanoma pipeline report depicts a robust space with 150+ active players working to develop 170+ pipeline therapies for Melanoma treatment.
* The leading Melanoma Companies such as IO Biotech, Moderna Inc., Merck Sharp & Dohme LLC, BioNTech SE, TILT Biotherapeutics LLC, Nykode Therapeutics, Achilles Therapeutics UK Limited, Evaxion Biotech, InxMed, AiVita Biomedical, Cytovation AS, Ono Pharmaceuticals, Neon Therapeutics, Iovance Biotherapeutics , and others.
* Promising Melanoma Therapies such as Ipilimumab, GM-CSF, Temozolomide, Tilsotolimod, Pembrolizumab, Lenvatinib, L19IL2 + L19TNF , and others.

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Melanoma Emerging Drugs Profile

* IO102 IO103 : IO Biotech

IO102-IO103 is an investigational immune-modulating therapeutic cancer vaccine designed to target the immunosuppressive mechanisms mediated by the proteins indoleamine 2,3-dioxygenase (IDO) and programmed death-ligand 1 (PD-L1). IDO and/or PD-L1 are overexpressed by many types of solid tumors and immune-suppressive cells (Tregs and TAMs) in the TME. The company is developing this vaccine based on its T-win Registered vaccine platform. Currently it is in Phase III stage of clinical trial evaluation to treat Melanoma.

* mRNA 4157: Moderna Inc.

mRNA-4157/V940 is a novel investigational messenger ribonucleic acid (mRNA)-based personalized cancer vaccine consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed to stimulate an immune response by generating specific T cell responses based on the unique mutational signature of a patient's tumor. The drug is been developed jointly by Moderna & Merck. Currently being evaluated in the Phase III studies.

* MK-4830: Merck Sharp & Dohme LLC

MK-4830 is an investigational monoclonal antibody that inhibits the binding of Immunoglobulin-like transcript 4 (ILT-4) to its ligands. The drug candidate is being developed in combination with KEYTRUDA. MK-4830 is being developed under an agreement with Agenus Inc. Currently the drug is being evaluated in Phase II for the treatment of Colorectal Cancer.

* BNT111: BioNTech SE

BNT111 is an intravenous therapeutic cancer immunotherapy candidate encoding a fixed set of four cancer-specific antigens optimized for immunogenicity and delivered as RNA-lipoplex formulation. The drug induces novel antigen-specific anti-tumor immune responses and enhances pre-existing immune responses against the encoded melanoma-associated antigens. The drug is in Phase II stage of clinical trials.

* TILT 123: TILT Biotherapeutics LLC

TILT-123 is a human 5/3 chimeric adenovirus that has been engineered to encode human Tumor Necrosis Factor alpha (hTNFa) and human Interleukin 2 (hIL-2) cytokines. It is optimized to generate an anti-cancer immune response by boosting the activity of T-cells and also stimulating other arms of the innate and adaptive immune system. TILT-123 can be administered by intravenous, intratumoral, intraperitoneal and intrapleural injection. The drug is in Phase I stage of clinical trials.

The Melanoma Pipeline report provides insights into

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

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Melanoma Companies

IO Biotech, Moderna Inc., Merck Sharp & Dohme LLC, BioNTech SE, TILT Biotherapeutics LLC, Nykode Therapeutics, Achilles Therapeutics UK Limited, Evaxion Biotech, InxMed, AiVita Biomedical, Cytovation AS, Ono Pharmaceuticals, Neon Therapeutics, Iovance Biotherapeutics , and others.

Melanoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration

* Oral
* Parenteral
* intravenous
* Subcutaneous
* Topical

Melanoma Products have been categorized under various Molecule types such as

* Monoclonal Antibody
* Peptides
* Polymer
* Small molecule
* Gene therapy

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Scope of the Melanoma Pipeline Report

* Coverage- Global
* Melanoma Companies- IO Biotech, Moderna Inc., Merck Sharp & Dohme LLC, BioNTech SE, TILT Biotherapeutics LLC, Nykode Therapeutics, Achilles Therapeutics UK Limited, Evaxion Biotech, InxMed, AiVita Biomedical, Cytovation AS, Ono Pharmaceuticals, Neon Therapeutics, Iovance Biotherapeutics, and others.
* Melanoma Therapies- Ipilimumab, GM-CSF, Temozolomide, Tilsotolimod, Pembrolizumab, Lenvatinib, L19IL2 + L19TNF, and others.
* Melanoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Melanoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

For a detailed overview of our latest research findings and future plans, read the full details of Melanoma Pipeline on our website @ Melanoma Emerging Drugs and Companies [https://www.delveinsight.com/sample-request/melanoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Table of Contents

* Introduction
* Executive Summary
* Melanoma: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Late Stage Products (Phase III)
* Comparative Analysis
* IO102 IO103 : IO Biotech
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* MK-4830: Merck Sharp & Dohme LLC
* Early Stage Products (Phase I)
* Comparative Analysis
* TILT 123: TILT Biotherapeutics LLC
* Inactive Products
* Melanoma Key Companies
* Melanoma Key Products
* Melanoma- Unmet Needs
* Melanoma- Market Drivers and Barriers
* Melanoma- Future Perspectives and Conclusion
* Melanoma Analyst Views
* Melanoma Key Companies
* Appendix

About Us

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