Advanced Melanoma - Pipeline Insight, 2024

This “Advanced Melanoma - Pipeline Insight, 2024” 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, a challenging form of skin cancer, poses significant treatment complexities due to its ability to spread to distant parts of the body, known as metastasis. This aggressive disease, characterized by its resistance to traditional therapies, has seen a transformative shift in treatment approaches with the advent of immunotherapies, targeted therapies, vaccines, and combination treatments. The management of advanced melanoma focuses on shrinking or removing tumors, preventing further spread, and alleviating symptoms, with treatments like surgery, radiation, immunotherapy, targeted therapy, and chemotherapy playing crucial roles in enhancing patient outcomes and quality of life. Melanoma is caused by environmental, genetic, and immunological factors, with research focusing on immune system activation for targeted therapies. Specific genes associated with melanoma predisposition include CDKN2A, CDK4, MC1R, and the genetic disorder xeroderma pigmentosum, which impairs UV-induced DNA damage repair. The increasing incidence is particularly notable in White race females.

Primary melanoma is treated with surgical removal of the tumor through wide excision or Mohs micrographic surgery, which provides a definitive cure. Late-stage melanoma, characterized by metastasis, is challenging to treat due to its refractory nature and high genomic variability. The treatment of metastatic melanoma has advanced significantly in recent years, with the approval of Vemurafenib (Zelboraf) as a highly selective inhibitor of mutated BRAFV600E. However, patients relapse within 8-12 months due to reactivation of the MAPK pathway or other mutations. Combining BRAF inhibitors with other MAPK inhibitors like MEK or ERK offers additional benefits but increases toxicity. Despite progress, an inhibitor against RAS has not been developed, although a KRASG12C inhibitor showed tumor regression in KRAS-mutant tumor models. Its efficacy against NRAS-mutated melanomas remains unclear.

The risk factors for developing melanoma include sun exposure, especially to UV radiation, which is a major contributor to skin cancer development. Other risk factors include having many moles or atypical moles, fair skin, a family history of melanoma, previous skin cancer, older age, male gender, certain inherited genetic conditions, weakened immune system, and specific genetic mutations like CDKN2A. These factors increase the likelihood of developing melanoma, emphasizing the importance of sun protection, regular skin checks, and genetic screening for individuals with a higher risk profile.

"Advanced Melanoma- Pipeline Insight, 2024" 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/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

Tebentafusp: Immunocore

Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. Tebentafusp has been granted Priority Review; Real Time Oncology Review; Breakthrough Therapy designation; Fast Track designation; and orphan drug designation by the FDA in the United States; orphan drug status in the European Union; and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. The drug is currently being evaluated under Phase II/III clinical trial for the treatment of Advanced Melanoma.

TAVO: OncoSec Medical

TAVO is DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions. TAVO is administered directly into the tumor using OncoSec’s proprietary EP gene delivery system, which employs a series of momentary energy pulses. Those pulses are designed to increase the permeability of the cell membrane and facilitate uptake of IL-12 coded DNA into the tumor cells. The drug is currently being evaluated under Phase II clinical trials 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. Phase II/III include, Immunocore.

Phases

This 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

• Intravenous
• Subcutaneous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide
• 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 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

• OncoSec Medical
• Immunocore
• Sanofi
• TILT Biotherapeutics
• Novartis Pharmaceuticals
• Sumitomo Pharma
• BioMed Valley Discoveries
• Replimune
• ImaginAb
• Shanghai Pharmaceuticals
• Seagen
• Karyopharm Therapeutics
• Hoffmann-La Roche

Key Products

• TAVO
• Tebentafusp
• THOR-707
• TILT-123
• TNO155
• TP-0903
• Ulixertinib
• Vusolimogene Oderparepvec
• Zirconium Zr 89
• T3011
• SGN-BB228
• Selinexor
• RO6874281

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