Cutaneous Squamous Cell Carcinoma - Pipeline Insight, 2024

This “Cutaneous Squamous Cell Carcinoma- Pipeline Insight, 2024” report provides comprehensive insights about 45+ companies and 45+ pipeline drugs in Cutaneous Squamous Cell Carcinoma 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

Cutaneous Squamous Cell Carcinoma: Understanding

Cutaneous Squamous Cell Carcinoma: Overview

Cutaneous squamous cell carcinoma (SCC) is a common type of keratinocyte cancer, or non-melanoma skin cancer. It is derived from cells within the epidermis that make keratin - the horny protein that makes up skin, hair and nails. Cutaneous SCC is an invasive disease, referring to cancer cells that have grown beyond the epidermis. SCC can sometimes metastasize and may prove fatal. More than 90% of cases of SCC are associated with numerous DNA mutations in multiple somatic genes. Mutations in the p53 tumor suppressor gene are caused by exposure to ultraviolet radiation (UV), especially UVB (known as signature 7). Other signature mutations relate to cigarette smoking, ageing and immune suppression (eg, to drugs such as azathioprine). Mutations in signalling pathways affect the epidermal growth factor receptor, RAS, Fyn, and p16INK4a signalling. Beta-genus human papillomaviruses (wart virus) are thought to play a role in SCC arising in immune-suppressed populations. ß-HPV and HPV subtypes 5, 8, 17, 20, 24, and 38 have also been associated with an increased risk of cutaneous SCC in immunocompetent individuals. Cutaneous SCCs present as enlarging scaly or crusted lumps. They usually arise within pre-existing actinic keratosis or intraepidermal carcinoma. Distinct clinical types of invasive cutaneous SCC include: Cutaneous horn - the horn is due to excessive production of keratin, Keratoacanthoma (KA) - a rapidly growing keratinising nodule that may resolve without treatment, Carcinoma cuniculatum (‘verrucous carcinoma’), a slow-growing, warty tumour on the sole of the foot, Marjolin ulcer - a cutaneous SCC that has developed in a scar or chronic ulcer and Multiple eruptive SCC/KA-like lesions arising in syndromes, such as multiple self-healing squamous epitheliomas of Ferguson-Smith and Grzybowski syndrome. Diagnosis of cutaneous SCC is based on clinical features. The diagnosis and histological subtype are confirmed pathologically by diagnostic biopsy or following excision. Patients with high-risk SCC may also undergo staging investigations to determine whether it has spread to lymph nodes or elsewhere. These may include: Imaging using ultrasound scan, X-rays, CT scans, MRI scans and Lymph node or other tissue biopsies. Cutaneous SCC is nearly always treated surgically. Most cases are excised with a 3-10 mm margin of normal tissue around a visible tumour. A flap or skin graft may be needed to repair the defect. There is a great deal of evidence to show that very careful sun protection at any time of life reduces the number of SCCs. This is particularly important in ageing, sun-damaged, fair skin; in patients that are immune suppressed; and in those who already have actinic keratoses or previous SCC.

Cutaneous Squamous Cell Carcinoma- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Cutaneous Squamous Cell Carcinoma pipeline landscape is provided which includes the disease overview and Cutaneous Squamous Cell Carcinoma treatment guidelines. The assessment part of the report embraces, in depth Cutaneous Squamous Cell Carcinoma 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, Cutaneous Squamous Cell Carcinoma 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 Cutaneous Squamous Cell Carcinoma R&D. The therapies under development are focused on novel approaches to treat/improve Diffuse Large B-Cell Lymphoma.

Cutaneous Squamous Cell Carcinoma Emerging Drugs Chapters

This segment of the Cutaneous Squamous Cell Carcinoma 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.

Cutaneous Squamous Cell Carcinoma Emerging Drugs

HLX 07: Shanghai Henlius Biotech HLX07 is a bio-better independently developed by Henlius. Adopting the self-developed advanced antibody engineering platform, Henlius re-engineered cetuximab by humanizing its Fab regions and minimizing its glycan contents to generate HLX07 to reduce the immunogenicity and increase the affinity of the product. Pre-clinical studies have shown that HLX07 binds EGFR with similar affinity and had better bioactivity compared to cetuximab. Henlius holds patents of HLX07 in several jurisdictions including China, the United States, the European Union, Australia, and Japan. Moreover, Henlius has received clinical trial approvals for HLX07 in the treatment of solid tumors in Chinese mainland, the United States, and Taiwan China. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Cutaneous Squamous CellCarcinoma.

Opzelura: Incyte Corporation Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK inhibitor approved for use in the United States for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Cutaneous Squamous CellCarcinoma.

RM 1995: Rakuten Medical RM-1995, developed by Rakuten Medical using its IlluminoxTM platform, is an antibody-dye conjugate comprised of a monoclonal antibody specific for cell-surface interleukin 2 (IL-2) receptor a-chain (CD25) and IRDye® 700DX (IR700), a light-activatable dye. RM-1995 photo immunotherapy is designed to specifically kill CD25+ regulatory T cells (Tregs) within solid tumors, once illuminated with 690nm nonthermal red light. Rakuten Medical's preclinical data has suggested that RM-1995 photo immunotherapy treatment can be utilized to specifically deplete intratumoral Tregs, thereby alleviating local Treg-mediated restraint within the tumor microenvironment, rapidly improving the CD8 T cell: Treg ratio, and reinvigorating effector CD8+ T cell responses. Currently, the drug is in Phase I stage of Clinical trial evaluation for the treatment of Cutaneous Squamous CellCarcinoma.

Cutaneous Squamous Cell Carcinoma: Therapeutic Assessment

This segment of the report provides insights about the different Cutaneous Squamous Cell Carcinoma drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Cutaneous Squamous Cell Carcinoma

There are approx. 45+ key companies which are developing the therapies for Cutaneous Squamous Cell Carcinoma. The companies which have their Cutaneous Squamous Cell Carcinoma drug candidates in the most advanced stage, i.e. Phase II include, Incyte Corporation.

Phases

This report covers around 45+ 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

Cutaneous Squamous Cell Carcinoma pipeline report provides the therapeutic assessment of the pipeline drugs by the
Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

Product Type

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

Cutaneous Squamous Cell Carcinoma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Cutaneous Squamous Cell Carcinoma 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 Cutaneous Squamous Cell Carcinoma drugs.

Cutaneous Squamous Cell Carcinoma Report Insights

• Cutaneous Squamous Cell Carcinoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Incyte Corporation
• Shanghai Henlius Biotech
• Novartis
• Rakuten Medical
• Morphogenesis
• Genentech
• Berg Pharma
• I-MAB Biopharma
• Roche
• Genexine
• CureVac

Key Products

• HLX 07
• Opzelura
• RM 1995
• ASP-1929
• IFx-Hu2.0
• Atezolizumab
• API31510
• NT-I7
• CV8102

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