Acral Lentiginous Melanoma - Pipeline Insight, 2025

This “Acral Lentiginous Melanoma - Pipeline Insight, 2025” report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Acral Lentiginous 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.

Acral Lentiginous Melanoma: Understanding

Acral Lentiginous Melanoma: Overview

Acral lentiginous melanoma (ALM), sometimes referred to simply as acral melanoma, is a rare form of melanoma that typically occurs on the hands and feet, including the palms, soles, fingers, toes, and nail units. The term 'acral' derives from the Greek word referring to the extremities, while 'lentiginous' describes the tumor's initial appearance as a flat, brown macule resembling a benign lentigo. First identified as a distinct subtype of Cutaneous Malignant Melanoma (CMM) by Arrington et al. in 1977, ALM represents only 2-3% of melanoma cases. Unlike other types of melanoma, UV radiation is not a significant contributing factor to its development. ALM most commonly appears on the lower extremities and is often diagnosed at an advanced stage, contributing to higher morbidity and mortality. This subtype has a disproportionately higher incidence in non-white populations compared to other melanoma forms.

Multiple studies have suggested that stress or shearing forces may play a role in the development of ALM, given its higher incidence in weight-bearing areas of the foot, such as the heel, forefoot, and lateral side. ALM is rarer in the arch of the foot, although it has been observed to occur more frequently in obese individuals. Interestingly, recent research found that after adjusting for surface area, ALM was inversely proportional to the presence of atypical and benign acral nevi in these weight-bearing areas. The incidence of ALM may be higher on plantar surfaces compared to the palm due to the greater melanocytic density in the sole. Some studies have also linked penetrative injuries to an increased likelihood of ALM, though the exact pathogenesis remains unclear. Unlike other forms of cutaneous malignant melanoma, ALM does not typically exhibit the UV-induced mutations seen in other melanoma subtypes, suggesting that genetic factors may contribute more significantly to its development.

ALM, like mucosal melanomas, is characterized by a low mutational burden and lacks the UV-induced mutations commonly found in other cutaneous melanomas. Common genetic mutations in ALM include KIT, BRAF, NRAS, and NF1, with KIT copy number gains identified in up to 36% of cases, making it the most frequent mutation in ALM. Chromosomal instability in the Cyclin D1 gene is also commonly observed, occurring in 45% of cases, and is associated with the 'field effect,' where melanocytes surrounding the atypical lesion carry similar mutations, potentially contributing to local recurrences. FISH analysis has shown alterations such as CCND1 and MYC gains, as well as CDKN2A loss. TERT promoter mutations, prevalent in UV-induced melanomas, are rare in ALM, although other TERT gene alterations, including copy gains, translocations, and mutations, are found in up to 41% of cases. The variability of genetic aberrations in ALM may be influenced by ethnicity, which has been proposed as a factor in the carcinogenesis of ALM.

Wide local excisions remain the primary treatment for ALM, with surgical margins determined by tumor thickness at the time of biopsy. In cases where surgery is not feasible, excision of in-situ lesions may be considered. Topical imiquimod has been studied off-label for ALM treatment; however, its use is limited by challenges such as the persistence of in-situ lesions, the risk of missing invasive lesions due to lack of excision, lesion progression, and the high cost. For cases with clinically detected metastases, or when confirmed through sentinel lymph node biopsy, systemic treatments including chemotherapy, targeted mutational therapies, and immune checkpoint inhibitors may be necessary. However, for patients with asymptomatic high-stage disease, early treatment prior to symptom onset has not shown a survival benefit.

'Acral Lentiginous Melanoma- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Acral Lentiginous Melanoma pipeline landscape is provided which includes the disease overview and Acral Lentiginous Melanoma treatment guidelines. The assessment part of the report embraces, in depth Acral Lentiginous 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, Acral Lentiginous 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 Acral Lentiginous Melanoma R&D. The therapies under development are focused on novel approaches to treat/improve Acral Lentiginous Melanoma.

Acral Lentiginous Melanoma Emerging Drugs Chapters

This segment of the Acral Lentiginous 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.

Acral Lentiginous Melanoma Emerging Drugs

MDNA11: Medicenna Therapeutics, Inc.

MDNA11 is a long-acting IL-2 Superkine that has been fused with human recombinant albumin, which increases its half-life and minimizes dosing requirements without sacrificing efficacy and safety. This Superkine has been designed to preferentially bind the IL-2 beta receptor (IL-2Rβ) on immune cells and to become a powerful switch for activating and proliferating the immune cells needed to fight cancer. It is being developed specifically as a therapeutic for various solid tumors, potentially in combination with other immunotherapies. MDNA11 has the ability to preferentially stimulate cancer-fighting NK cells and naive CD8 cells instead of immuno-suppressive regulatory T cells, by 80 and 200 fold, respectively, when compared to native IL-2. It does so by specifically binding to IL-2Rβ. and begins a cascade of events that overcomes the immune-suppressing effects of cancer and activates the cancer-killing immune cells - including cytotoxic T cells, naive T cells, and natural killer cells. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of Acral Lentiginous Melanoma.

Acral Lentiginous Melanoma: Therapeutic Assessment

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

Major Players in Acral Lentiginous Melanoma

• There are approx. 3+ key companies which are developing the therapies for Acral Lentiginous Melanoma. The companies which have their Acral Lentiginous Melanoma drug candidates in the stage, i.e. Phase I/II include, Medicenna Therapeutics.

Phases

The report covers around 3+ 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

Acral Lentiginous 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.

Acral Lentiginous Melanoma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Acral Lentiginous 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 Acral Lentiginous Melanoma drugs.

Acral Lentiginous Melanoma Report Insights

• Acral Lentiginous Melanoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Tizona Therapeutics, Inc
• Turnstone Biologics
• Medicenna Therapeutics, Inc.

Innovent Biologics

Key Products

• TTX-080
• TBio-4101
• MDNA11
• IBI-310

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