Advanced Melanoma - Pipeline Insight, 2025

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

Geography Covered

• Global coverage

Advanced Melanoma: Understanding

Advanced Melanoma: Overview

Advanced melanoma is a particularly challenging and aggressive form of melanoma that typically refers to cases where the cancer has spread beyond its original site (usually the skin) to other parts of the body. This stage is often associated with a poor prognosis, especially when it involves critical areas such as the central nervous system (CNS). Advanced melanoma is resistant to many conventional treatments, including chemotherapy, radiation, and early targeted therapies, though significant progress has been made with new combinations of targeted therapies and immunotherapies. Despite these advances, it remains a highly aggressive cancer, and once metastasis occurs, it becomes difficult to treat due to the cancer’s ability to evade immune surveillance and bypass barriers like the blood-brain barrier.

The complexity of advanced melanoma is further compounded by genetic alterations such as MITF amplification, TERT promoter mutations, and CDKN2A loss, which are more commonly found in metastatic melanomas compared to primary melanomas. However, a clear understanding of the factors driving metastasis and therapeutic resistance is still elusive, highlighting the need for further research into the biology and pathophysiology of advanced melanoma.

As melanoma advances, it can spread to various organs, causing a range of symptoms depending on the location of metastasis. Lymph node involvement in advanced melanoma often presents with swollen or painful lymph nodes or hardened lumps under the skin. When the cancer spreads to the brain, symptoms can include headaches and seizures. Bone metastasis can lead to fractures and bone pain, while liver metastasis may cause symptoms such as loss of appetite, unexplained weight loss, and liver enlargement. If melanoma spreads to the lungs, patients may experience persistent coughing and difficulty breathing. Additionally, common symptoms in advanced melanoma include fatigue, weakness, and numbness in the arms or legs, signaling widespread disease.

The treatment of advanced melanoma varies based on the extent of disease progression, but the introduction of targeted therapies and immunotherapies has significantly transformed the treatment landscape in the past decade. For early-stage melanoma, surgical removal of the tumor, including wide excision and sentinel lymph node (SLN) biopsy, can provide curative intervention. However, for advanced melanoma, treatment options are focused on systemic therapies. BRAF/MEK inhibitors (such as vemurafenib, dabrafenib, and encorafenib) have shown efficacy in patients with BRAF mutations, though resistance can develop. Immune checkpoint inhibitors like pembrolizumab, nivolumab, and ipilimumab have revolutionized the treatment of metastatic melanoma, improving survival outcomes and leading to durable responses in some patients. Combination therapies have further enhanced the effectiveness of these treatments, but challenges remain in overcoming therapeutic resistance and managing drug-related toxicities.

"Advanced Melanoma- Pipeline Insight, 2025" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Advanced Melanoma pipeline landscape is provided which includes the disease overview and Advanced Melanoma treatment guidelines. The assessment part of the report embraces, in depth Advanced Melanoma commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Advanced Melanoma collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Advanced Melanoma R&D. The therapies under development are focused on novel approaches to treat/improve Advanced Melanoma.

Advanced Melanoma Emerging Drugs Chapters

This segment of the Advanced Melanoma report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Advanced Melanoma Emerging Drugs

• 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.

Advanced Melanoma: Therapeutic Assessment

This segment of the report provides insights about the different Advanced Melanoma drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Advanced Melanoma

• There are approx. 55+ key companies which are developing the therapies for Advanced Melanoma. The companies which have their Advanced Melanoma drug candidates in the most advanced stage, i.e. Registration include, Replimune.

Phases

The report covers around 60+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

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

Molecule Type

Products have been categorized under various Molecule types such as

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

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Advanced Melanoma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Advanced Melanoma therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Advanced Melanoma drugs.

Advanced Melanoma Report Insights

• Advanced Melanoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Advanced Melanoma Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Advanced Melanoma drugs?
• How many Advanced Melanoma drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Advanced Melanoma?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Advanced Melanoma therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Advanced Melanoma and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• 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

Key Products

• Vusolimogene oderparepvec
• IO102-IO103
• BNT111
• [203Pb]VMT01
• Botensilimab
• DF6215
• Dapansutrile
• Cyclophosphamide
• Ceritinib
• Ceralasertib
• Cabozantinib
• BT-001
• Brenetafusp
• BGB-A445
• BCD-263
• BA1302
• Azacitidine
• Autogene cevumeran
• AU-007
• AMT-253
• ABP 206

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