Human Papillomavirus 16-positive (HPV16+) Cancers- Pipeline Insight, 2025

This “Human papillomavirus 16-positive (HPV16+) cancers- Pipeline Insight, 2025” report provides comprehensive insights about 10+ companies and 12+ pipeline drugs in Human papillomavirus 16-positive (HPV16+) cancers 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.

Human papillomavirus 16-positive (HPV16+) cancers: Understanding

Human papillomavirus 16-positive (HPV16+) cancers: Overview

Human papillomavirus 16 (HPV16) is one of the high-risk strains of HPV, primarily linked to various cancers, including cervical, oropharyngeal, anal, and penile cancers. HPV16 is a DNA virus that infects epithelial cells, and it is transmitted through sexual contact. Persistent infection with HPV16 can lead to the development of malignant tumors, making it a significant public health concern. HPV16-positive cancers are more common in both men and women and have been increasing in prevalence, particularly oropharyngeal cancers. The signs and symptoms of HPV16-positive cancers depend on the site of infection. For cervical cancer, early stages often present no symptoms, but advanced stages may include irregular bleeding, pelvic pain, and discharge. Oropharyngeal cancers may present with persistent sore throat, difficulty swallowing, ear pain, and lumps in the neck. Anal cancer symptoms can include rectal bleeding, pain, and changes in bowel habits. Similarly, penile cancer might present with sores, discharge, or a lump on the penis. The asymptomatic nature of early HPV16 infection underscores the importance of regular screening and monitoring. HPV16 causes cancer by integrating its DNA into the host cell's genome, leading to the overexpression of viral oncoproteins E6 and E7. These proteins interfere with tumor suppressor pathways by inactivating p53 and retinoblastoma protein (pRb), respectively. The disruption of these pathways results in uncontrolled cell proliferation and genetic instability, which can eventually lead to cancer. Persistent infection, rather than transient infection, is critical for the development of malignancy. Factors such as immune suppression, genetic predisposition, and co-infections can influence the progression from infection to cancer.

Diagnosis of HPV16-positive cancers involves a combination of clinical examination, imaging, and laboratory tests. For cervical cancer, Pap smears and HPV DNA testing are essential for early detection. Colposcopy and biopsy confirm the diagnosis. Oropharyngeal cancers are often diagnosed through physical examination, imaging studies (like MRI or CT scans), and biopsy of suspicious lesions. HPV DNA testing can also identify the presence of high-risk HPV types. Anal and penile cancers require similar diagnostic approaches, including visual inspection, biopsy, and HPV testing. The integration of molecular techniques enhances the accuracy of diagnosis and helps in guiding treatment.

The treatment of HPV16-positive cancers depends on the cancer's location and stage. Early-stage cervical cancer is typically treated with surgery (conization or hysterectomy) and may include radiation and chemotherapy for advanced stages. Oropharyngeal cancers often require a combination of surgery, radiation therapy, and chemotherapy. For anal cancer, chemoradiation is the standard treatment, while penile cancer may involve surgical excision, radiation, or chemotherapy depending on the stage. Immunotherapy and targeted therapies are emerging treatment modalities showing promise. Preventative measures, including HPV vaccination and regular screenings, play a crucial role in reducing the incidence of these cancers. The HPV vaccine, effective against multiple high-risk strains including HPV16, is recommended for both boys and girls to prevent HPV-associated malignancies.

'Human papillomavirus 16-positive (HPV16+) cancers- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Human papillomavirus 16-positive (HPV16+) cancers pipeline landscape is provided which includes the disease overview and Human papillomavirus 16-positive (HPV16+) cancers treatment guidelines. The assessment part of the report embraces, in depth Human papillomavirus 16-positive (HPV16+) cancers 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, Human papillomavirus 16-positive (HPV16+) cancers 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 Human papillomavirus 16-positive (HPV16+) cancers R&D. The therapies under development are focused on novel approaches to treat/improve Human papillomavirus 16-positive (HPV16+) cancers.

Human papillomavirus 16-positive (HPV16+) cancers Emerging Drugs Chapters

This segment of the Human papillomavirus 16-positive (HPV16+) cancers 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.

Human papillomavirus 16-positive (HPV16+) cancers Emerging Drugs

ISA101b: ISA Pharmaceuticals

ISA101b consists of 12 synthetic long peptides derived from the E6 and E7 oncogenic proteins of the HPV 16 virus, a strain responsible for over 50% of human cervical cancers and cervical intra-epithelial neoplasias, more than 85% of HPV-positive head and neck cancers, and similar substantial percentages of other premalignant and malignant HPV-induced lesions (such as VIN, vulvar cancer, AIN and anal cancer). It is currently administered either subcutaneously or intradermally. ISA101 has completed a Phase II trial in vulvar intra-epithelial neoplasia, establishing clinical proof-of-concept. In cervical cancer, ISA101 has successfully completed a company-sponsored Phase I/II trial and has entered into further clinical development in collaboration with Regeneron. The alliance aims to develop and advance ISA101 in combination with cemiplimab (Libtayo®), a PD-1 (programmed cell death protein 1) antibody currently under review by EMA and initially approved by the U.S. Food and Drug Administration in September 2018 under the brand name Libtayo® as monotherapy for patients with advanced cutaneous squamous cell carcinoma. Currently, the drug is in Phase II stage of its development for the treatment of HPV16-Positive Oropharyngeal Cancer (OPC).

CUE-101: Cue Biopharma

The CUE-100 series of biologics have the potential to improve efficacy and reduce the severe toxicities associated with non-specific IL-2 cancer immunotherapies. They are engineered to selectively engage and modulate tumor-specific immune T cells by taking advantage of the specificity already existing in nature, and avoid toxicities associated with indiscriminate immune activation. CUE-101, has already demonstrated clinical activity and favorable tolerability as a monotherapy in a Phase I trial in patients with human papilloma virus (HPV16+) recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). This validates the clinical applicability of our technology platforms and therapeutic potential of our advanced pipeline of biologics for the treatment of cancer. Currently, the drug is in Phase II stage of its development for the treatment of Oropharyngeal Squamous Cell Carcinoma.

Human papillomavirus 16-positive (HPV16+) cancers: Therapeutic Assessment

This segment of the report provides insights about the different Human papillomavirus 16-positive (HPV16+) cancers drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Human papillomavirus 16-positive (HPV16+) cancers

• There are approx. 10+ key companies which are developing the therapies for Human papillomavirus 16-positive (HPV16+) cancers. The companies which have their Human papillomavirus 16-positive (HPV16+) cancers drug candidates in the most advanced stage, i.e. phase III include, ISA Pharmaceuticals.

Phases

The report covers around 15+ 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

Human papillomavirus 16-positive (HPV16+) cancers 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.

Human papillomavirus 16-positive (HPV16+) cancers: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Human papillomavirus 16-positive (HPV16+) cancers 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 Human papillomavirus 16-positive (HPV16+) cancers drugs.

Human papillomavirus 16-positive (HPV16+) cancers Report Insights

• Human papillomavirus 16-positive (HPV16+) cancers Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Human papillomavirus 16-positive (HPV16+) cancers 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 Human papillomavirus 16-positive (HPV16+) cancers drugs?
• How many Human papillomavirus 16-positive (HPV16+) cancers drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Human papillomavirus 16-positive (HPV16+) cancers?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Human papillomavirus 16-positive (HPV16+) cancers 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 Human papillomavirus 16-positive (HPV16+) cancers and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• ISA Pharmaceuticals
• Cue Biopharma
• Genexine
• Vaccibody AS
• PDS Biotechnology
• BlueSky Immunotherapies GmbH

Key Products

• ISA101b
• CUE-101
• GX 188E
• VB 10.16
• PDS 0101
• FluBHPVE6E7

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