Head and Neck Cancer Pipeline

DelveInsight’s, “Head and Neck cancer (HNC) - Pipeline Insight, 2025” report provides comprehensive insights about 80+ companies and 100+ pipeline drugs in Head and Neck cancer (HNC) 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

 

Head and Neck cancer (HNC): Understanding

Head and Neck cancer (HNC): Overview

Head and neck cancer encompasses a diverse group of malignancies that arise in the squamous cells lining the mucosal surfaces of the oral cavity, pharynx, larynx, nasal cavity, and paranasal sinuses, as well as in the salivary glands and other structures within the head and neck region. These cancers are most commonly squamous cell carcinomas and are strongly associated with risk factors such as tobacco use, alcohol consumption, and infection with high-risk strains of human papillomavirus (HPV), particularly HPV-16. Symptoms can vary depending on the tumor’s location but may include a persistent sore throat, difficulty swallowing, hoarseness, a lump in the neck, or unexplained weight loss. Due to their proximity to critical structures, these cancers can significantly impact speech, swallowing, and appearance, often affecting the patient’s quality of life. Early diagnosis and a multidisciplinary treatment approach—typically involving surgery, radiation therapy, and chemotherapy—are essential for improving outcomes and preserving function.

 

The signs and symptoms of head and neck cancer can vary widely depending on the specific site and extent of the tumor, but they often overlap with those of benign conditions, making early detection challenging. Common symptoms include a persistent sore throat, hoarseness or voice changes, difficulty or pain while swallowing (dysphagia), and a non-healing ulcer or sore in the mouth. Patients may also experience swelling or a lump in the neck, ear pain, unexplained weight loss, or a feeling of something stuck in the throat. In cancers involving the nasal cavity or sinuses, symptoms might include nasal obstruction, frequent nosebleeds, or facial pain. Those with advanced disease may present with cranial nerve deficits, trismus (difficulty opening the mouth), or persistent bad breath. Any symptom that persists for more than two to three weeks should be evaluated by a healthcare provider, as early identification is crucial for effective treatment and improved prognosis.

 

The pathophysiology of head and neck cancer involves the malignant transformation of epithelial cells, most commonly resulting in squamous cell carcinoma. This transformation is driven by cumulative genetic and molecular changes, including mutations in tumor suppressor genes like *TP53* and *CDKN2A*, as well as overactivation of oncogenes such as *EGFR*. Major risk factors such as tobacco use, alcohol consumption, and infection with high-risk human papillomavirus (HPV), particularly HPV-16, contribute significantly to these alterations. HPV-related cancers involve viral oncoproteins E6 and E7, which inactivate key regulatory proteins like p53 and Rb, promoting uncontrolled cell growth. As the cancer progresses, malignant cells invade local tissues and spread through the rich lymphatic system of the head and neck, often leading to regional lymph node metastasis. The tumor also promotes angiogenesis and evades immune detection, further aiding its growth and dissemination. These molecular and cellular changes underlie the aggressive nature of head and neck cancers and influence both prognosis and therapeutic approaches.

 

The treatment and management of head and neck cancer depend on the tumor’s location, stage, histological type, and the patient's overall health. A multidisciplinary approach is essential, typically involving surgery, radiation therapy, chemotherapy, or a combination of these modalities. Early-stage cancers may be effectively treated with a single modality—either surgery or radiation—while advanced-stage disease often requires a combination of surgery followed by radiation or chemoradiation to ensure local and regional control. Chemotherapy, commonly using agents like cisplatin, is often used concurrently with radiation in locally advanced cases or as part of palliative care in metastatic disease. Targeted therapies, such as EGFR inhibitors (e.g., cetuximab), and immunotherapy agents like immune checkpoint inhibitors (e.g., pembrolizumab or nivolumab) have shown promise, particularly in recurrent or metastatic settings. Supportive care, including nutritional support, speech and swallowing therapy, pain management, and psychosocial support, plays a critical role in improving quality of life and treatment outcomes. Regular follow-up is crucial for monitoring recurrence, managing long-term side effects, and rehabilitating functional impairments caused by the disease or its treatment.

 

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

 

Head and Neck cancer (HNC) Emerging Drugs Chapters

This segment of the Head and Neck cancer (HNC) 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 (HNC) Emerging Drugs

• Petosemtamab: Merus

Petosemtamab, or MCLA-158, is a Biclonics® low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity. Petosemtamab granted Breakthrough Therapy designation by the US FDA for 1L PD-L1 positive head and neck squamous cell carcinoma. Currently, the drug is in Phase III stage of its development for the treatment of Head and Neck cancer (HNC).

 

• Ficerafusp alfa: Bicara Therapeutics

Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-b signaling within the tumor microenvironment. Currently, the drug is in Phase II/III stage of its development for the treatment of Head and Neck cancer (HNC).

 

• Tipifarnib: Kura Oncology, Inc

Tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. In extensive clinical trials, tipifarnib has shown a well-established safety profile and compelling and durable anti-cancer activity in certain patient subsets. Preclinical and clinical data suggest that, in the appropriate context, tipifarnib has the potential to provide significant benefit to cancer patients with limited treatment options. In addition to its development program in solid tumors with HRAS mutations, Kura has identified potential biomarkers of activity for tipifarnib in hematologic malignancies, including peripheral T-cell lymphomas (PTCL), myelodysplastic syndromes (MDS), acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). Currently, the drug is in Phase II stage of its development for the treatment of Head and Neck cancer (HNC).

 

• VCN-01: Theriva Biologics

VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to over 140 patients to date in clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). Currently, the drug is in Phase I/II stage of its development for the treatment of Head and Neck cancer (HNC).

 

• VB10.16: Nykode Therapeutics ASA

VB10.16 is a potentially first-in-class off-the-shelf therapeutic DNA-based cancer vaccine candidate in development for the treatment of human papillomavirus type 16 (HPV16)-positive cancers. The cancer vaccine is designed based on Nykode’s Vaccibody™ technology platform of targeting antigens to antigen presenting cells. The vaccine-induced significant HPV16-specific T cell responses in clinical studies that were correlated with clinical responses. Currently, the drug is in Phase I/II stage of its development for the treatment of Head and Neck cancer (HNC).

 

• CUE 101: Cue Biopharma

CUE-101 is a fusion protein designed to activate and expand tumor-specific T cells, directly in the patient’s body, that target Human Papilloma 16 (HPV16)-driven malignancies. It contains IL-2 and a pMHC composed of HLA-A*02:01 complexed with a dominant peptide derived from the E7 protein of human papilloma virus 16 (HPV 16-E7). CUE-101 is the lead immuno-oncology drug developed within the IL-2 based CUE-100 framework from Cue Biopharma’s novel Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform technology. In November 2018, LG Chem Life Sciences partnered with Cue Biopharma to develop and commercialize cancer immunotherapy drugs based on the Immuno-STAT platform technology. Currently, the drug is in Phase I stage of its development for the treatment of Head and Neck cancer (HNC).

Further product details are provided in the report……..

 

Head and Neck cancer (HNC): Therapeutic Assessment

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

Major  Players in Head and Neck cancer (HNC)

There are approx. 80+ key companies which are developing the therapies for Head and Neck cancer (HNC). The companies which have their Head and Neck cancer (HNC) drug candidates in the most advanced stage, i.e. Phase III include, Merus.

 

Phases

DelveInsight’s 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 (HNC) 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 (HNC): Pipeline Development Activities

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

 

Head and Neck cancer (HNC) Report Insights

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

Head and Neck cancer (HNC) 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 (HNC) drugs?
• How many Head and Neck cancer (HNC) 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 (HNC)?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Head and Neck cancer (HNC) 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 (HNC) and their status?
• What are the key designations that have been granted to the emerging drugs?