Head And Neck Cancer - Pipeline Insight, 2025

This “Head and Neck cancer - Pipeline Insight, 2025” report provides comprehensive insights about 80+ companies and 100+ pipeline drugs in Head and Neck 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.

Head and Neck cancer: Understanding

Head and Neck cancer: Overview

Head and neck cancer is the term given to cancers that start in the head and neck region. Cancers that are known collectively as head and neck cancers usually begin in the squamous cells that line the mucosal surfaces of the head and neck (for example, those inside the mouth, throat, and voice box). These cancers are referred to as squamous cell carcinomas of the head and neck. Head and neck cancers can also begin in the salivary glands, sinuses, or muscles or nerves in the head and neck, but these types of cancer are much less common than squamous cell carcinomas. These cancers can begin in any of these places: Voice box or larynx, Nasal cavity, Mouth or oral cavity, Paranasal sinuses, spaces around the nose, lined with cells that make mucus that keeps the nose from drying out, Throat or pharynx and also in Salivary glands.

Head and Neck cancer (HNC) encompasses a variety of malignancies originating in the squamous cells lining the mucosal surfaces of the oral cavity, pharynx, and larynx. The pathophysiology of HNC is complex, involving a series of genetic mutations and epigenetic alterations that lead to uncontrolled cell proliferation, resistance to apoptosis, angiogenesis, and metastasis. Key molecular changes include mutations in tumor suppressor genes like TP53 and oncogenes such as EGFR, as well as aberrant activation of signaling pathways like PI3K/AKT and MAPK. Additionally, lifestyle factors such as tobacco and alcohol use, along with infection by human papillomavirus (HPV), particularly in oropharyngeal cancers, significantly contribute to the disease process. These factors collectively disrupt normal cellular regulation, leading to the aggressive and invasive nature of HNC.

If the healthcare provider thinks patient may have head and neck cancer, person need some tests to be sure. Person be asked about health history, symptoms, risk factors, and family history of disease. A physical exam will be done. Person may also have one or more tests, such as blood tests, X-rays, or a computed tomography (CT) scan. A biopsy is the only way to know for sure that person have cancer. Small pieces of the tumor are taken out and checked for cancer cells. They may also be tested for signs of HPV infection. After a diagnosis of head and neck cancer, patient needs more tests. These help learn more about the overall health and the cancer. They're used to find the stage of the cancer. The stage is how much cancer there is and how far it has spread (metastasized) in the body. It's one of the most important things to know when deciding how to treat the cancer.

Head and neck cancer treatment can include surgery, radiation therapy, chemotherapy, targeted therapy, immunotherapy, or a combination of treatments. The treatment plan for an individual patient depends on a number of factors, including the location of the tumor, the stage of the cancer, and the person’s age and general health. Research has shown that patients with HPV-positive oropharyngeal tumors have a much better prognosis and higher chance of complete cure than those with HPV-negative tumors following the same treatment. Because of this, ongoing clinical trials are investigating whether patients with HPV-positive cancers can be treated with less intensive regimens, such as less intensive radiation or immunotherapy.

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

Head and Neck cancer Emerging Drugs Chapters

This segment of the Head and Neck 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.

Head and Neck cancer Emerging Drugs

Xevinapant: Debiopharm/Merck

Xevinapant is a potent, orally available, inhibitor of IAPs (Inhibitor of Apoptosis Proteins). IAP inhibitors restore sensitivity to apoptosis in cancer cells and thereby deprive them of one of their major resistance mechanisms. This class of products is therefore particularly suited to be combined with widely used but often sub-optimal chemo- and radiotherapy (CRT). As leader of the class, xevinapant established proof of efficacy in high-risk locally advanced squamous cell carcinoma of the head and neck (LASCCHN) patients for which the combination provided highly significant and sustainable clinical benefit as compared to CRT alone. Increasing tumor cell sensitivity to chemoradiotherapy constitutes a highly promising strategy for xevinapant which ultimately may improve treatment outcomes for these high-risk patients and other cancer patients currently treated with similar regimens. In addition to combination with CRT, xevinapant is also being investigated in combination with chemotherapy as well as checkpoint inhibitors. An exclusive license agreement has been granted to Merck in 2021 for its further development and commercialization. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Head and Neck cancer.

Dostarlimab: GlaxoSmithKline

Dostarlimab, developed by GlaxoSmithKline (GSK), is a humanized monoclonal antibody that targets the programmed death-1 (PD-1) receptor, enhancing the body's immune response against various cancers, including head and neck cancer. It has shown promise in several clinical trials, particularly for cancers characterized by mismatch repair deficiency (dMMR) and microsatellite instability-high (MSI-H) statuses. Dostarlimab functions by inhibiting the interaction between PD-1 receptors on T-cells and their ligands (PD-L1) on tumor cells. This blockade allows T-cells to more effectively recognize and attack cancer cells, thereby promoting tumor regression. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Head and Neck cancer.

Tigilanol tiglate: QBiotics Group Limited

It is a short-chain diterpene ester isolated from the seed of Fontainea picrosperma, with potential antineoplastic activity. Upon intratumoral administration, tigilanol tiglate disrupts mitochondrial functioning and induces mitochondrial swelling, which leads to oncolysis of tumor cells that are in direct contact of the agent. In addition, tigilanol tiglate activates protein kinase C (PKC) signaling cascade, which leads to an acute inflammatory response. This results in hypoxia and activates innate immune cells including neutrophils and macrophages, thereby further killing tumor cells. The activation of the beta-II isoform of PKC (PKC beta II) also increases tumor vasculature permeability, which leads to the destruction of tumor vasculature. Currently, the drug is in the Phase II stage of development to treat Head and Neck cancer.

MEM-288: Memgen, Inc.

MEM-288 is an innovative oncolytic adenovirus developed by Memgen, Inc., designed as a cancer immunotherapy targeting solid tumors. It incorporates two key transgenes: human interferon beta (IFNβ) and a proprietary recombinant chimeric CD40 ligand (CD40L). This combination aims to enhance the immune system's response against cancer cells, particularly in patients whose tumors have not responded to existing therapies, such as checkpoint inhibitors. Currently, the drug is in the Phase I stage of development to treat Head and Neck cancer.

Head and Neck cancer: Therapeutic Assessment

This segment of the report provides insights about the different Head and Neck cancer drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Head and Neck cancer

• There are approx. 80+ key companies which are developing the therapies for Head and Neck cancer. The companies which have their Head and Neck cancer drug candidates in the most advanced stage, i.e. Phase III include, GlaxoSmithKline and Debiopharm/Merck.

Phases

The report covers around 100+ 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

Head and Neck 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.

Head and Neck cancer: Pipeline Development Activities

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

Head and Neck cancer Report Insights

• Head and Neck cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Debiopharm
• Merck
• GlaxoSmithKline
• QBiotics Group Limited
• Memgen, Inc.

BioNTech

• Alentis Therapeutics AG
• Beijing CorreGene Biotechnology
• Coordination Pharmaceuticals, Inc.

Regeneron Pharmaceuticals

• Sichuan Baili Pharmaceutical Co., Ltd.

TILT Biotherapeutics Ltd.

Coherus Biosciences, Inc.

Key Products

• Xevinapant
• Dostarlimab
• Tigilanol tiglate
• MEM-288
• BNT 113
• ALE.C04
• CRTE7A2-01
• RiMO-301
• REGN6569
• BL-B16D1
• TILT-123
• CHS-114

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