Vulvar Cancer - Pipeline Insight, 2025

This “Vulvar Cancer - Pipeline Insight, 2025” report provides comprehensive insights about 10+ companies and 12+ pipeline drugs in Vulvar 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.

Vulvar Cancer: Understanding

Vulvar Cancer: Overview

Vulvar cancer is recognized as the fourth most common gynecologic malignancy, accounting for approximately 5% of all female genital tract cancers. The most common histological type is squamous cell carcinoma (SCC), which represents about 95% of cases, with rarer forms such as melanoma and basal cell carcinoma also observed. The etiology of vulvar cancer is multifactorial, with significant associations to both viral and non-viral factors. Human papillomavirus (HPV) infection, particularly high-risk types such as HPV-16 and HPV-18, is strongly linked to vulvar cancer in younger women, while non-viral factors such as chronic inflammatory conditions and lichen sclerosus are more commonly seen in older women. Common clinical symptoms of vulvar cancer include pruritus (itching), vulvar bleeding, and pain, which often result in delayed diagnosis.

The epidemiology of vulvar cancer provides important insights into its incidence, demographics, and risk factors. Although vulvar cancer is relatively rare, it accounts for about 5% of all gynecologic malignancies and approximately 1% of all cancers in women. In the United States, the age-adjusted incidence rate of vulvar cancer is approximately 2.6 per 100,000 women per year, with a median age at diagnosis around 69 years. The disease predominantly affects older women, especially those aged 65 to 74, though a significant proportion of cases also occur in younger women. These younger cases are often associated with human papillomavirus (HPV) infection and vulvar intraepithelial neoplasia (VIN). Epidemiological studies have highlighted HPV as a major risk factor, particularly types 16 and 18, which are strongly linked to the development of invasive vulvar cancer.

The pathophysiology of vulvar cancer involves complex interactions between genetic, viral, and environmental factors that lead to the transformation of normal vulvar epithelial cells into malignant ones. The majority of vulvar cancers, particularly squamous cell carcinoma (SCC), are linked to persistent infection with high-risk strains of human papillomavirus (HPV), especially types 16 and 18. These HPV strains produce oncoproteins E6 and E7, which disrupt normal cell cycle regulation by interfering with host cell proteins, resulting in uncontrolled cellular proliferation and evasion of apoptosis. This disruption facilitates the development of precancerous lesions, known as vulvar intraepithelial neoplasia (VIN), which can progress to invasive cancer if left untreated. In addition to HPV-related mechanisms, vulvar cancer can also arise from non-viral factors, especially in older women.

The diagnosis of vulvar cancer involves a thorough and systematic approach, starting with a detailed medical history and physical examination. During the initial evaluation, healthcare providers perform a pelvic exam to inspect the vulva for any abnormal lesions or changes. If suspicious areas are detected, a colposcopy may be conducted, using a magnifying instrument to closely examine the vulvar tissue for further abnormalities. A biopsy is essential for confirming the diagnosis; this procedure involves extracting a small sample of tissue from the affected area for histopathological analysis to determine the presence of cancerous cells. Imaging studies, including computed tomography (CT) scans, magnetic resonance imaging (MRI), and positron emission tomography (PET) scans, are often used to assess the extent of the disease, checking for metastasis to nearby lymph nodes or other organs.

The treatment and management of vulvar cancer involve a personalized, multidisciplinary approach based on the stage of the disease and the patient’s overall health. Surgery is the primary treatment modality, with procedures ranging from radical wide local excision to partial or radical vulvectomy, depending on the size and extent of the tumor. Early-stage cancers can often be effectively treated with complete surgical removal, leading to favorable outcomes. In more advanced cases, or when the cancer has spread, radiation therapy may be used either as adjuvant treatment to eliminate residual cancer cells or as a primary option for patients who cannot undergo surgery.

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

Vulvar Cancer Emerging Drugs Chapters

This segment of the Vulvar Cancer 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.

Vulvar Cancer Emerging Drugs

TG4001: Transgene

TG4001 is an innovative therapy capable of combating papillomavirus-induced cancers. The concept behind TG4001 is to teach the immune system to recognise and destroy the cancer cells expressing HPV-16 antigens, specifically E6 and E7 antigens. The company has selected typical papillomavirus sequences that code for these antigens and have incorporated them into the DNA of a viral vector (MVA). It has also introduced a gene that codes for a molecule (interleukin 2, IL-2) that will stimulate the immune system at the injection site. TG4001 triggers a specific immune response that supports the recognition and destruction of cancer cells carrying the HPV viral antigens. This approach enables the body to destroy the tumours. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Vulvar Cancer.

GI-101: GI Innovation, Inc.

GI-101 is a novel immunotherapeutic agent developed by GI Innovation, Inc., designed as a bispecific fusion protein that combines CD80 and an interleukin-2 (IL-2) variant. This innovative drug aims to enhance anti-tumor immunity by targeting the cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and preferentially binding to the IL-2 receptor beta subunit (IL-2Rβ). Preclinical studies have demonstrated that GI-101 exhibits strong anti-tumor efficacy, stimulating the proliferation of CD8+ T cells and natural killer (NK) cells while minimizing the expansion of regulatory T cells, which are often implicated in immune suppression within the tumor microenvironment. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of Vulvar Cancer.

HRYZ-T101: HRYZ Biotech Co.

HRYZ-T101 is an innovative therapeutic agent developed by HRYZ Biotech Co., designed to target various cancers through a unique mechanism of action. It is a novel bispecific T-cell engager (BiTE) that aims to enhance the immune system's ability to recognize and eliminate cancer cells. By simultaneously binding to CD3 on T cells and a specific tumor-associated antigen (TAA), HRYZ-T101 facilitates the activation and proliferation of T cells in the presence of tumor cells, thereby promoting targeted cytotoxicity against malignant tissues. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Vulvar Cancer.

Vulvar Cancer: Therapeutic Assessment

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

Major Players in Vulvar Cancer

• There are approx. 10+ key companies which are developing the therapies for Vulvar Cancer. The companies which have their Vulvar Cancer drug candidates in the most advanced stage, i.e. Phase III include, Shanghai Bovax Biotechnology Co., Ltd.

Phases

The report covers around 12+ 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

Vulvar 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.

Vulvar Cancer: Pipeline Development Activities

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

Vulvar Cancer Report Insights

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

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

Key Players

• TScan Therapeutics, Inc.

Transgene

• Marengo Therapeutics, Inc.

SCG Cell Therapy Pte. Ltd.

HRYZ Biotech Co.

GI Innovation, Inc.

Key Products

• TSC-204-A0201
• TG4001
• STAR0602
• SCG142
• HRYZ-T101
• GI-101

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