Thursday, April 3, 2025

Head and Neck Cancer Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

Head and Neck Cancer Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “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 Head and Neck Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Head and Neck Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Discover the latest drugs and treatment options in the Head and Neck Cancer Pipeline. Dive into DelveInsight's comprehensive report today! @ Head and Neck Cancer Pipeline Outlook

Key Takeaways from the Head and Neck Cancer Pipeline Report

  • In March 2025, QBiotics Group Limited announced a phase II, Open Label, Single Arm Study To Assess The Efficacy Of Intratumoral Tigilanol Tiglate In Various Head And Neck Solid Malignancies.
  • In March 2025, Coordination Pharmaceuticals Inc. announced a phase 1b/2a Study of RiMO-301 and Hypofractionated Radiotherapy With A PD-1 Inhibitor for the Treatment of Unresectable, Recurrent or Metastatic Head-Neck Cancer.
  • In March 2025, Boehringer Ingelheim conducted a phase III study will be performed in patients with recurrent and/or metastatic head and neck cancer which has progressed after platinum-based therapy. The objectives of this trial are to compare the efficacy and safety of afatinib versus methotrexate.
  • In March 2025, Merck Sharp & Dohme LLC organized a study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
  • In March 2025, Incyte Biosciences International organized a study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).
  • DelveInsight’s Head and Neck Cancer pipeline report depicts a robust space with 80+ active players working to develop 100+ pipeline therapies for Head and Neck Cancer treatment.
  • The leading Head and Neck Cancer Companies such as 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.
  • Promising Head and Neck Cancer Therapies such as RiMO-301, Pembrolizumab, Dostarlimab, Belrestotug, Nelistotug, Methotrexate, Afatinib, and others.

Stay ahead with the most recent pipeline outlook for Head and Neck Cancer. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Head and Neck Cancer Treatment Drugs

 

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.

Explore groundbreaking therapies and clinical trials in the Head and Neck Cancer Pipeline. Access DelveInsight's detailed report now! @ New Head and Neck Cancer Drugs

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.

Head and Neck cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration

  • Oral
  • Intravenous
  • Subcutaneous
  • Parenteral
  • Topical

Head and Neck Cancer Products have been categorized under various Molecule types such as

  • Monoclonal Antibody
  • Peptides
  • Polymer
  • Small molecule
  • Gene therapy

Unveil the future of Head and Neck Cancer Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Head and Neck Cancer Market Drivers and Barriers

Scope of the Head and Neck Cancer Pipeline Report

  • Coverage- Global
  • 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.
  • Head and Neck Cancer Therapies- RiMO-301, Pembrolizumab, Dostarlimab, Belrestotug, Nelistotug, Methotrexate, Afatinib, and others.
  • Head and Neck Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Head and Neck Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Get the latest on Head and Neck Cancer Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Head and Neck Cancer Companies, Key Products and Unmet Needs

Table of Content

  1. Introduction
  2. Executive Summary
  3. Head and Neck Cancer: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Late Stage Products (Phase III)
  7. Xevinapant: Debiopharm/Merck
  8. Drug profiles in the detailed report…..
  9. Mid Stage Products (Phase II)
  10. Tigilanol tiglate: QBiotics Group Limited
  11. Drug profiles in the detailed report…..
  12. Early Stage Products (Phase I)
  13. MEM-288: Memgen, Inc.
  14. Drug profiles in the detailed report…..
  15. Preclinical and Discovery Stage Products
  16. Drug name: Company name
  17. Drug profiles in the detailed report…..
  18. Inactive Products
  19. Head and Neck Cancer Key Companies
  20. Head and Neck Cancer Key Products
  21. Head and Neck Cancer - Unmet Needs
  22. Head and Neck Cancer - Market Drivers and Barriers
  23. Head and Neck Cancer - Future Perspectives and Conclusion
  24. Head and Neck Cancer Analyst Views
  25. Head and Neck Cancer Key Companies
  26. Appendix

About Us

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