Anal Cancer - Pipeline Insight, 2024

This “Anal Cancer - Pipeline Insight, 2024” report provides comprehensive insights about 6+ companies and 8+ pipeline drugs in Anal Cancer 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

Anal Cancer: Understanding

Anal Cancer: Overview

Anal cancer is a rare condition, although its incidence has been increasing over the past several decades, particularly in women. The majority of anal cancers are squamous cell cancers and are linked with human papillomavirus (HPV) infection. There is a clear correlation between human papillomavirus (HPV) infection, mainly HPV 16, and anal cancer. Hence, there is an increased incidence in certain populations, such as young men who have genital viral infections. A large study highlighted a correlation between the amount of sexual activity and venereal infections. Earlier low-powered studies linked anal-receptive intercourse to an increased risk of anal cancer, but this has not been confirmed in a large trial. In addition to HPV, condylomata infections have been implicated in anal cancer in the general population and homosexual men. A study showed that in women with genital warts, anal cancer was associated with the Human Papillomavirus and Chlamydia trachomatis. Conversely, in men with no history of genital warts, there was an association with gonorrhea infection. In addition to the etiologies mentioned above, there has been an association between acquired immunodeficiency syndrome (AIDS) and anal cancer. In patients infected with the human immunodeficiency virus (HIV), the risk of anal cancer is 40 times higher compared to the general population.

The pathophysiology of the development of anal cancer is believed to be directly linked to a complex inflammatory process secondary to infections such as HPV (particularly serotypes 16 and 18). In a Scandinavian study, serotype 16 was detected in 73% of anal cancer specimens, and serotypes 16, 18, or both were present in 84% of the specimens. The progression of this inflammatory process heralds the development of anal intraepithelial neoplasia (AIN) or squamous cell carcinoma in situ (Bowen disease), which is a pre-malignant condition. Anal intraepithelial neoplasia can be graded from I to III depending on the abnormalities in differentiation and maturation of the squamous layers, mitotic activity, nuclear membrane changes, and the depth of those abnormalities. AIN can subsequently progress to invasive squamous cell carcinoma (SCC), and this occurs in 10% to 11% of cases. HIV-positive patients have a higher rate of conversion to squamous cell carcinoma, even if AIDS has not manifested. Most anal cancers are squamous or colitogenic cancers with a few adenocarcinomas and rarely melanoma. Tumors tend to spread by local extension but also have the potential to metastasize.

Many anal cancers are found early because they are in a location that your physician can easily see and reach. Diagnosis is often made when people with any of the symptoms undergo an anal exam. Anal cancer may also be found incidentally during yearly physical exams that include a digital rectal exam. The rectal exam is performed to check the rectum, prostate, or other pelvic organs. Anal cancers can also be found when a person has a preventive colorectal screening test (such as a colonoscopy).

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

Anal Cancer Emerging Drugs Chapters

This segment of the Anal Cancer 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.

Anal Cancer Emerging Drugs

PDS0101: Merck & CoPDS0101 is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by a simple subcutaneous injection in combination with other immunotherapies and cancer treatments. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments demonstrates significant disease control by shrinking tumors, delaying disease progression, and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents. Currently, the drug is being evaluated in the Phase II stage of its development for the treatment of patients with anal cancer.

BMX-001: BioMimetixBMX-001 is a metalloporphyrin, a novel class of redox-active, small molecule. The active center is designed to mimic the center of superoxide dismutase. The primary mechanism of action is modulation of cellular signaling pathways. BMX-001 inhibits both NFkB and HIF-1a. By inhibiting these pro-survival and pro-angiogenic transcription factors, BMX-001 augments tumor killing by radiation therapy and inhibits tumor regrowth. The inhibition of NFkB blocks major components of the inflammatory cascade which simultaneously results in protection of normal tissue from radiation induced injury. The drug is in phase I/II of clinical trials for the treatment of anal cancer.

Anal Cancer: Therapeutic Assessment

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

Major Players in Anal Cancer

• There are approx. 6+ key companies which are developing the therapies for Anal Cancer. The companies which have their Anal Cancer drug candidates in the most advanced stage, i.e. phase II include, Merck & Co.

Phases

This report covers around 8+ 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

Anal Cancer 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.

Anal Cancer: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Anal Cancer 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 Anal Cancer drugs.

Anal Cancer Report Insights

• Anal Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Incyte Corporation
• Merck & Co
• Novartis Pharmaceuticals
• Advaxis
• Merck KGaA

Key Products

• Retifanlimab
• PDS0101
• KFA-115
• ADXS11-001
• Avelumab

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