Head and Neck Cancer Clinical Pipeline | 80+ Companies Leading the Next Breakthroughs

The head and neck cancer market is undergoing a transformative shift, driven by groundbreaking research and innovative therapies that are redefining treatment possibilities.

DelveInsight's 'Head and Neck Cancer Pipeline Insight 2024' report provides comprehensive global coverage of pipeline Head and Neck Cancer therapies in various stages of clinical development. Major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Head and Neck Cancer pipeline domain.

For Head and Neck Cancer emerging drugs, the Head and Neck Cancer pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Head and Neck Cancer Pipeline Report
• DelveInsight's Head and Neck Cancer Pipeline analysis depicts a robust space with 80+ active players working to develop 100+ pipeline drugs for Head and Neck Cancer treatment.
• The leading Head and Neck Cancer companies include 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., and others are evaluating their lead assets to improve the Head and Neck Cancer treatment landscape.
• Key Head and Neck Cancer pipeline therapies in various stages of development include Leukocyte Interleukin, Zanzalintinib + pembrolizumab, Xevinapant, Dostarlimab, Tigilanol tiglate, MEM-288, and others.
• In February 2025, Merck announced that the FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) as a neoadjuvant treatment, followed by adjuvant treatment in combination with standard radiotherapy (with or without cisplatin), for patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
• In February 2025, Cedars-Sinai successfully performed the first robot-assisted microsurgical reconstructive surgery for head and neck cancer in the U.S., following FDA approval of the robotic device, marking a significant surgical advancement.
• In February 2025, Pyxis Oncology, Inc. received FDA Fast Track Designation for its investigational drug PYX-201 to treat adult patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy.
• In October 2024, CEL-SCI Corporation renewed its collaboration with Ergomed Clinical Research for a confirmatory FDA Registration Study of Multikine® (Leukocyte Interleukin, Injection) in head and neck cancer.
• In August 2024, the FDA granted Fast Track designation to APG-157 for neoadjuvant treatment of head and neck cancer. APG-157 is a first-in-class botanical drug designed to deliver active components to oromucosal tissues near the tumor target.

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Head and Neck Cancer Overview
Head and neck cancer (HNC) refers to cancers that originate in the head and neck region. These cancers typically begin in the squamous cells lining the mucosal surfaces of areas like the mouth, throat, and voice box, and are known as squamous cell carcinomas of the head and neck. Less commonly, HNC can also arise in the salivary glands, sinuses, or muscles and nerves in the head and neck. The primary locations for these cancers include the voice box (larynx), nasal cavity, mouth (oral cavity), paranasal sinuses (spaces around the nose lined with mucus-producing cells), throat (pharynx), and salivary glands.

The pathophysiology of HNC is intricate, involving genetic mutations and epigenetic changes that result in uncontrolled cell growth, resistance to cell death, angiogenesis, and metastasis. Key molecular alterations include mutations in tumor suppressor genes such as TP53, as well as oncogene activation like EGFR and abnormal signaling pathways, including PI3K/AKT and MAPK. Lifestyle factors such as tobacco and alcohol use, along with human papillomavirus (HPV) infection, particularly in oropharyngeal cancers, play a major role in the development of the disease. These factors disrupt normal cellular regulation, leading to the aggressive and invasive nature of HNC.

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Head and Neck Cancer Treatment Analysis: Drug Profile
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.

Key Head and Neck Cancer Therapies and Companies
• Leukocyte Interleukin (MULTIKINE): CEL-SCI
• Zanzalintinib + pembrolizumab: Exelixis
• Xevinapant: Debiopharm/Merck
• Dostarlimab: GlaxoSmithKline
• Tigilanol tiglate: QBiotics Group Limited

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Head and Neck Cancer Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Scope of the Head and Neck Cancer Pipeline Report
• Coverage: Global
• Key Head and Neck Cancer Companies: 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., and others.
• Key Head and Neck Cancer Pipeline Therapies: Leukocyte Interleukin, Zanzalintinib + pembrolizumab, Xevinapant, Dostarlimab, Tigilanol tiglate, MEM-288, and others.

Dive deep into rich insights for drugs used for Head and Neck Cancer treatment; visit @ https://www.delveinsight.com/report-store/head-and-neck-cancer-hnc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Head and Neck Cancer Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Head and Neck Cancer Pipeline Therapeutics
6. Head and Neck Cancer Pipeline: Late-Stage Products (Phase III)
7. Head and Neck Cancer Pipeline: Late-Stage Products (Phase III)
8. Head and Neck Cancer Pipeline: Mid-Stage Products (Phase II)
9. Head and Neck Cancer Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

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jvimal@delveinsight.com
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Healthcare Consulting
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About DelveInsight
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This release was published on openPR.