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.

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Key Takeaways from the Advanced Melanoma Pipeline Report

• In May 2025, Innovent Biologics (Suzhou) Co. Ltd. announced a phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects with Advanced Melanoma.
• In May 2025, Iovance Biotherapeutics Inc. conducted a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.
• In May 2025, Anaveon AG organized a study is to evaluate the efficacy and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma. The study has 3 parts. Part 1 to evaluate ANV419 in monotherapy and Parts 2 and 3 to evaluate ANV419 in combination with anti-PD1 antibody or anti-CTLA4 antibody. Parts 2 and 3 were not initiated, as the prespecified efficacy criteria to graduate to Part 2 were not met at the interim analysis of Part 1.
• In May 2025, iOnctura announced a study will enrol approximately 85 male and female patients aged over 18 years with advanced or metastatic UM, who have progressed following at least 1 prior immunotherapy treatment. The disease must be measurable (i.e., at least 1 measurable lesion) as per RECIST v1.1 by Computerised Tomography (CT) scan or Magnetic Resonance Imaging (MRI).
• In May 2025, Iovance Biotherapeutics Inc. organized a study is the first-in-human (FIH) study of IOV-3001. IOV-3001 is an antibody interleukin-2 (IL-2) fusion protein in which a modified form of aldesleukin is incorporated into the antibody palivizumab. The Phase 1 portion will include 2 parts. Participants will receive IOV-3001 either before the Lifileucel regimen (Part 1) or after Lifileucel instead of aldesleukin (Part 2).
• 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.

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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® 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

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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

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

Table of Content

1. Introduction
2. Executive Summary
3. Advanced Melanoma: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Advanced Melanoma– DelveInsight’s Analytical Perspective
7. Late Stage Products (Registration)
8. Vusolimogene oderparepvec: Replimune
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. BNT111: BioNTech SE
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. Botensilimab: Agenus Inc.
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. Advanced Melanoma Key Companies
21. Advanced Melanoma Key Products
22. Advanced Melanoma- Unmet Needs
23. Advanced Melanoma- Market Drivers and Barriers
24. Advanced Melanoma- Future Perspectives and Conclusion
25. Advanced Melanoma Analyst Views
26. Advanced Melanoma Key Companies
27. Appendix

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