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

DelveInsight's, "Advanced Melanoma Pipeline Insight 2025" report provides comprehensive insights about 55+ companies and 60+ pipeline drugs in Advanced Melanoma pipeline landscape. It covers the Advanced Melanoma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Advanced Melanoma pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Discover the latest drugs and treatment options in the Advanced Melanoma Pipeline. Dive into DelveInsight's comprehensive report today! @ Advanced Melanoma Pipeline Outlook [https://www.delveinsight.com/sample-request/advanced-melanoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Key Takeaways from the Advanced Melanoma Pipeline Report

* On 22 August 2025, Eikon Therapeutics announced a Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants with Advanced Melanoma. The study includes dose optimization and expansion parts.
* On 22 August 2025, H. Lee Moffitt Cancer Center and Research Institute organized a Phase 2 open-label, single-arm study of neoadjuvant treatment of intratumoral tavo-EP plus nivolumab IV infusion. Eligible participants will be those with pathological diagnosis of operable locally-regionally advanced melanoma.
* On 20 August 2025, Grupo Espanol Multidisciplinar de Melanoma conducted a phase 2 study to evaluate the ORR of pembrolizumab in combination with enfortumab vedotin (EV) in previously treated participants with unresectable stage III or IV melanoma and disease progression on standard therapy.
* DelveInsight's Advanced Melanoma Pipeline report depicts a robust space with 55+ active players working to develop 60+ pipeline therapies for Advanced Melanoma treatment.
* The leading Advanced Melanoma Companies such as Replimune, IO Biotech, BioNTech SE, Perspective Therapeutics, Agenus Inc., Dragonfly Therapeutics, Olatec Therapeutics LLC, Iovance Biotherapeutics, Inc., Novartis Pharmaceuticals, AstraZeneca, Exelixis, Transgene, Immunocore Ltd, BeiGene, Biocad, Shandong Boan Biotechnology Co., Ltd, Merck Sharp & Dohme LLC, Genentech, Inc., Aulos Bioscience, Inc., Multitude Therapeutics Inc., Amgen and others.
* Promising Advanced Melanoma Pipeline Therapies such as Tebentafusp, T3011, IMC-F106C, Relatlimab, HLX208, DCB-BO1301, Pembrolizumab , and others.

Stay ahead with the most recent pipeline outlook for Advanced Melanoma. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Advanced Melanoma Treatment Drugs [https://www.delveinsight.com/sample-request/advanced-melanoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Advanced Melanoma Emerging Drugs Profile

* Vusolimogene oderparepvec: Replimune

Vusolimogene oderparepvec (RP1) is based on a proprietary strain of herpes simplex virus and is genetically prepared with a fusogenic protein, GALV-GP R- and GM-CSF. The drug is intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response. The unique formulation of RP1 includes a fusogenic protein, GALV-GP R-, and granulocyte-macrophage colony-stimulating factor (GM-CSF), which work synergistically to maximize the therapeutic effects. RP1 has also been granted Priority review by the FDA in combination with Nivolumab to treat advanced melanoma. Currently, the drug is in Registration stage of its development for the treatment of Advanced Melanoma.

* IO102-IO103: IO Biotech

IO102-IO103 combines our two wholly owned T-win Registered vaccines, IO102 and IO103, that are designed to activate and expand T cells specific for IDO1 and PD-L1, respectively. IDO1 and/or PD-L1 are overexpressed by many types of solid tumors and immune-suppressive cells (Tregs and TAMs) in the TME. By combining IO102 and IO103, the product is intended to have a synergistic effect on cells in the TME that express IDO1 and/or PD-L1, leading to enhanced cell killing. In clinical trials, IO-102-IO-103 plus nivolumab achieved rapid, deep, and durable responses, even in patients with one or more poor prognostic factors (e.g., M1c, and high LDH), without increasing high-grade adverse events over anti-PD-1 therapy alone. The FDA has also granted Breakthrough Therapy Designation for IO102-IO103 in combination with an anti-PD-1 monoclonal antibody for patients with advanced melanoma. Currently, the drug is in Phase III stage of its development for the treatment of Advanced Melanoma.

* BNT111: BioNTech SE

BNT111 is an mRNA cancer vaccine candidate encoding a fixed set of four melanoma-associated antigens aiming to trigger a strong and precise immune response in patients with anti-PD-(L) 1 refractory/relapsed, unresectable Stage III or IV melanoma. BNT111 is an mRNA-based off-the-shelf cancer immunotherapy candidate for intravenous administration encoding a fixed set of four non-mutated melanoma-associated antigens (NY-ESO-1, MAGE-A3, tyrosinase, and TPTE) delivered as uridine mRNA-lipoplex formulation. Over 90% of patients with cutaneous melanomas express at least one of these antigens. The BNT111 program has also received Fast Track designation and Orphan Drug designation from the U.S. Food and Drug Administration. Currently, the drug is in Phase II stage of its development for the treatment of Advanced Melanoma.

* [203Pb]VMT01: Perspective Therapeutics

VMT01 is a theranostic radiopharmaceutical developed by Perspective Therapeutics, specifically designed for the treatment of unresectable or metastatic melanoma. VMT01 is being developed to target and deliver 212Pb to tumor sites expressing MC1R, a protein that can be overexpressed in metastatic melanoma tumors. This compound targets the melanocortin 1 receptor (MC1R), which is often overexpressed in melanoma cells, enabling precise delivery of the alpha-emitting isotope 212Pb directly to tumor sites. The mechanism of action of VMT01 involves two distinct pathways: it induces direct cell killing through high-dose radiation while also promoting an immunogenic response that enhances immune-mediated tumor destruction at lower doses. This dual action not only aims to improve local tumor control but also stimulates systemic anti-tumor immunity. VMT01 has also received Fast Track Designation from the FDA. Currently, the drug is in Phase I/II stage of its development for the treatment of Advanced Melanoma.

* Botensilimab: Agenus Inc.

Botensilimab is an investigational multifunctional anti-CTLA-4 immune activator (antibody) designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Currently, the drug is in Phase I stage of its development for the treatment of Advanced Melanoma.

The Advanced Melanoma Pipeline Report Provides Insights into

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

Explore groundbreaking therapies and clinical trials in the Advanced Melanoma Marketed and Pipeline Drugs. Access DelveInsight's detailed report now! @ New Advanced Melanoma Drugs [https://www.delveinsight.com/sample-request/advanced-melanoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Advanced Melanoma Companies

Replimune, IO Biotech, BioNTech SE, Perspective Therapeutics, Agenus Inc., Dragonfly Therapeutics, Olatec Therapeutics LLC, Iovance Biotherapeutics, Inc., Novartis Pharmaceuticals, AstraZeneca, Exelixis, Transgene, Immunocore Ltd, BeiGene, Biocad, Shandong Boan Biotechnology Co., Ltd, Merck Sharp & Dohme LLC, Genentech, Inc., Aulos Bioscience, Inc., Multitude Therapeutics Inc., Amgen and others.

Advanced 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

* Oral
* Intravenous
* Subcutaneous
* Parenteral
* Topical

Advanced Melanoma Products have been categorized under various Molecule types such as

* Recombinant fusion proteins
* Small molecule
* Monoclonal antibody
* Peptide
* Polymer
* Gene therapy

Unveil the future of Advanced Melanoma Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Advanced Melanoma Market Drivers and Barriers [https://www.delveinsight.com/sample-request/advanced-melanoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Scope of the Advanced Melanoma Pipeline Report

* Coverage- Global
* Advanced Melanoma Companies- Replimune, IO Biotech, BioNTech SE, Perspective Therapeutics, Agenus Inc., Dragonfly Therapeutics, Olatec Therapeutics LLC, Iovance Biotherapeutics, Inc., Novartis Pharmaceuticals, AstraZeneca, Exelixis, Transgene, Immunocore Ltd, BeiGene, Biocad, Shandong Boan Biotechnology Co., Ltd, Merck Sharp & Dohme LLC, Genentech, Inc., Aulos Bioscience, Inc., Multitude Therapeutics Inc., Amgen and others.
* Promising Advanced Melanoma Pipeline Therapies such as Tebentafusp, T3011, IMC-F106C, Relatlimab, HLX208, DCB-BO1301, Pembrolizumab , and others.
* Advanced Melanoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Advanced Melanoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Get the latest on Advanced Melanoma Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Advanced Melanoma Companies, Key Products and Unmet Needs [https://www.delveinsight.com/sample-request/advanced-melanoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Table of Content

* Introduction
* Executive Summary
* Advanced Melanoma: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Advanced Melanoma- DelveInsight's Analytical Perspective
* Late Stage Products (Registration)
* Vusolimogene oderparepvec: Replimune
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* BNT111: BioNTech SE
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* Botensilimab: Agenus Inc.
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Advanced Melanoma Key Companies
* Advanced Melanoma Key Products
* Advanced Melanoma- Unmet Needs
* Advanced Melanoma- Market Drivers and Barriers
* Advanced Melanoma- Future Perspectives and Conclusion
* Advanced Melanoma Analyst Views
* Advanced Melanoma Key Companies
* Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Yash Bhardwaj
Email:Send Email [https://www.abnewswire.com/email_contact_us.php?pr=advanced-melanoma-pipeline-outlook-2025-clinical-trial-studies-ema-pdma-fda-approvals-moa-roa-nda-ind-and-companies]
Phone: 09650213330
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/report-store/advanced-melanoma-pipeline-insight

Legal Disclaimer: Information contained on this page is provided by an independent third-party content provider. ABNewswire makes no warranties or responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you are affiliated with this article or have any complaints or copyright issues related to this article and would like it to be removed, please contact retract@swscontact.com



This release was published on openPR.