Untreated Metastatic or Unresectable Melanoma - Pipeline Insight, 2024

This “Untreated Metastatic or Unresectable Melanoma- Pipeline Insight, 2024” report provides comprehensive insights about 22+ companies and 25+ pipeline drugs in Untreated Metastatic or Unresectable 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

Untreated Metastatic or Unresectable Melanoma: Understanding

Untreated Metastatic or Unresectable Melanoma: Overview

Metastatic or unresectable melanoma is an advanced stage of skin cancer where the malignant cells have spread from the primary site to other parts of the body or cannot be surgically removed. Melanoma originates in melanocytes, the cells responsible for producing melanin, the pigment that gives skin its color. When melanoma progresses to a metastatic or unresectable stage, it significantly impacts prognosis and requires a more complex treatment approach.

The signs and symptoms of metastatic melanoma vary depending on the organs involved. Common symptoms include persistent skin changes such as new growths, sores that do not heal, changes in existing moles (size, shape, color, or feel), and pigmentation spreading beyond the border of a mole. Symptoms specific to metastasis might include swollen lymph nodes, weight loss, fatigue, pain or tenderness in the bones, persistent cough or trouble breathing, and neurological symptoms if the brain is affected.

The primary cause of melanoma is DNA damage to melanocytes, often due to ultraviolet (UV) radiation from sunlight or tanning beds. Genetic predispositions also play a significant role. Mutations in the BRAF gene, present in about 50% of melanomas, lead to uncontrolled cell growth. As the cancer advances, malignant cells detach from the primary tumor, invade surrounding tissues, and spread through the lymphatic system or bloodstream to distant organs. This metastatic spread involves complex interactions between cancer cells and the body's immune system, often leading to immune evasion and further progression.

Diagnosis of metastatic melanoma begins with a thorough skin examination and history taking. Dermatoscopy is often used for initial assessment. Suspicious lesions are biopsied for histopathological examination. Advanced imaging techniques such as CT scans, MRI, PET scans, and sentinel lymph node biopsy are employed to determine the extent of metastasis. Genetic testing for mutations in genes like BRAF, NRAS, and KIT can guide targeted therapy decisions. Blood tests may also be conducted to check for elevated levels of lactate dehydrogenase (LDH), a marker of advanced disease.

Treatment for metastatic or unresectable melanoma has evolved significantly with advancements in targeted therapy and immunotherapy. Targeted therapies, such as BRAF inhibitors (vemurafenib, dabrafenib) and MEK inhibitors (trametinib, cobimetinib), are effective in patients with specific genetic mutations. Immunotherapies, including checkpoint inhibitors like nivolumab, pembrolizumab, and ipilimumab, enhance the body’s immune response against cancer cells. Combination therapies are common to overcome resistance and improve outcomes. For some patients, traditional treatments such as chemotherapy, radiation therapy, or surgical interventions might be used to manage symptoms or specific metastases. Clinical trials also offer access to novel therapies. Treatment plans are often individualized, considering factors like the patient’s overall health, location, and extent of metastasis.

"Untreated Metastatic or Unresectable Melanoma- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Untreated Metastatic or Unresectable Melanoma pipeline landscape is provided which includes the disease overview and Untreated Metastatic or Unresectable Melanoma treatment guidelines. The assessment part of the report embraces, in depth Untreated Metastatic or Unresectable 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, Untreated Metastatic or Unresectable 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 Untreated Metastatic or Unresectable Melanoma R&D. The therapies under development are focused on novel approaches to treat/improve Untreated Metastatic or Unresectable Melanoma.

Untreated Metastatic or Unresectable Melanoma Emerging Drugs Chapters

This segment of the Untreated Metastatic or Unresectable Melanoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase 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.

Untreated Metastatic or Unresectable Melanoma Emerging Drugs

Prolgolimab: Biocad

Prolgolimab is an IgG1 anti-PD-1 (programmed cell death protein 1) monoclonal antibody containing the Fc-silencing ‘LALA’ mutation. The drug candidate is designed to restore the anti-tumor activity of the human body’s immune response. The Ministry of Health of the Russian Federation has authorized a Russian originator drug for the treatment of unresectable or metastatic melanoma. The product was developed by BIOCAD, a biotechnology company; it is a fixed dose combination of two monoclonal antibodies, nurulimab and prolgolimab. The product will be marketed under the trade name Nurdati®. It is based on a 1:3 fixed dose combination of originator anti-CTLA-4 (nurulimab) and anti-PD-1 (prolgolimab) monoclonal antibodies. The product enhances the immune system capability of combating the tumor. Combining nurulimab and prolgolimab in the product promotes T cell activation at various stages of the immune response so they are able to recognize and destroy malignant cells. In other words, antitumor immunological surveillance is triggered and the body starts fighting against the malignant neoplasm. Currently, the drug is in Phase III stage of its development for the treatment of unresectable metastatic melanoma.

UV1: Ultimovacs ASA

UV1 is an off-the-shelf therapeutic cancer vaccine designed to induce a specific T cell response against telomerase. UV1 consists of long, synthetic peptides representing a sequence in the reverse transcriptase subunit of telomerase (hTERT), shown to induce CD4+ T cells. These CD4+ T cells have the potential to provide inflammatory signals and T cell support believed to be critical for triggering a strong anti-tumor immune response. The UV1 peptides contain several epitopes, shown to be non-restrictive in terms of (HLA) alleles for presentation. It is therefore not required to perform HLA pre-screening of patients, which potentially enables broad population utilization of the vaccine. UV1 is administered over three months with eight intradermal injections and the immune-modulator GM-CSF. In February 2024, US FDA granted Fast Track designation to UV1 in combination with ipilimumab and nivolumab for the treatment of patients with unresectable malignant pleural mesothelioma to improve overall survival, including first-line patients. Currently, the drug is in Phase II stage of its development for the treatment of unresectable metastatic melanoma.

ANV419: Anaveon AG

ANV419 is a powerful and selective IL-2 agonist, in patients with solid tumors which has been specifically designed to enable the delivery of high dose IL-2 to patients, with a favourable safety and tolerability profile. As of the data cut-off of 31 March 2023, 40 adult patients with advanced solid tumors and progression after ≥1 previous lines of systemic therapy were enrolled and received at least one dose of ANV419. The monotherapy was delivered as an intravenous infusion once every 2 weeks at doses up to 364 µg/kg. ANV419 was generally well tolerated, and drug-related adverse events were manageable, reversible, and responsive to supportive care therapy. ANV419 was generally well tolerated, and drug-related adverse events were manageable, reversible, and responsive to supportive care therapy. Currently, the drug is in Phase II stage of its development for the treatment of unresectable or metastatic melanoma.

BNT221: BioNTech US Inc.

BNT221 is a personal neoantigen-targeting T cell therapy candidate derived from patients’ peripheral blood cells (PBMC). The product candidate consists of multiple CD8+ and CD4+ T cell populations targeting multiple selected neoantigens unique to each patient's tumor. The proprietary stimulation process allows for the induction of T cells from the naïve as well as expansion of T cells from the memory compartment of the immune system. BNT221 is currently being evaluated in a first-in-human Phase I trial in patients with advanced unresectable or metastatic melanoma. Initial results show a manageable safety profile with no dose limiting toxicities and tumor regression in several patients with anti-PD-1 and anti-CTLA-4 pretreated advanced or metastatic melanoma.

Untreated Metastatic or Unresectable Melanoma: Therapeutic Assessment

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

Major Players in Untreated Metastatic or Unresectable Melanoma

• There are approx. 22+ key companies which are developing the therapies for Untreated Metastatic or Unresectable Melanoma. The companies which have their Untreated Metastatic or Unresectable Melanoma drug candidates in the most advanced stage, i.e. phase III include, Biocad.

Phases

This report covers around 25+ 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

Untreated Metastatic or Unresectable 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.

Untreated Metastatic or Unresectable Melanoma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Untreated Metastatic or Unresectable 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 Untreated Metastatic or Unresectable Melanoma drugs.

Untreated Metastatic or Unresectable Melanoma Report Insights

• Untreated Metastatic or Unresectable Melanoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Untreated Metastatic or Unresectable 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 Untreated Metastatic or Unresectable Melanoma drugs?
• How many Untreated Metastatic or Unresectable Melanoma drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Untreated Metastatic or Unresectable Melanoma?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Untreated Metastatic or Unresectable 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 Untreated Metastatic or Unresectable Melanoma and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Biocad
• Ultimovacs ASA
• Anaveon AG
• BioNTech US Inc.
• Iovance Biotherapeutics, Inc.
• MacroGenics
• Targovax Oy
• Istari Oncology, Inc.
• Scancell Ltd
• Takara Bio Inc.
• Turnstone Biologics, Corp.
• Amgen
• Multitude Therapeutics Inc.

Key Products

• Prolgolimab
• UV1
• ANV419
• BNT221
• IOV-4001
• Lorigerlimab
• ONCOS-102
• PVSRIPO
• SCIB1 DNA vaccine
• TBI-1401
• TBio-4101
• ABP 206
• AMT-253

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