Head and Neck Cancer Pipeline Therapeutics Appears Robust With 80+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

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 Pipeline Therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Head and Neck Cancer Pipeline Report

* In June 2025, M.D. Anderson Cancer Center announced a clinical research study is to learn if giving the new drug, Tarceva Registered (OSI-774), in combination with Platinol Registered (cisplatin) and Taxotere Registered (docetaxel) is effective in the treatment of metastatic or recurrent head and neck cancer. The safety of this treatment will also be studied.
* In June 2025, University of Colorado, Denver conducted a Phase Ib/II Study of NT219 in Combination With Pembrolizumab or Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
* In May 2025, M.D. Anderson Cancer Center announced a clinical research study is to learn if RAD001 in combination with Tarceva (erlotinib hydrochloride) can help to control head and neck squamous cell cancer (HNSCC). The safety of this drug combination will also be studied.
* In May 2025, Ascendis Pharma A/S conducted a study is to evaluate the safety and efficacy of TransCon TLR7/8 Agonist, TransCon IL-2 /, and pembrolizumab given prior to curative intent surgery in treatment of participants with newly diagnosed Stage III/IVA resectable locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). After surgery, participants will receive local standard-of-care treatment and will be followed for safety, efficacy, and survival for up to 2 years.
* 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 Merus, Bicara Therapeutics, Kura Oncology, Inc., Theriva Biologics, Nykode Therapeutics ASA, Cue Biopharma, BioNTech SE, Exelixis, AstraZeneca, Johnson & Johnson, Intragel, AbbVie, IOVANCE Biotherapeutics, Inc., Immutep Limited, Repertoire Immune Medicines, Pyxis Oncology, Inc., ALX Oncology, iTeos Therapeutics, AVEO Oncology, Akeso Biopharma, Coherus BioSciences, Inc., Flamingo Therapeutics, Adlai Nortye Ltd., Hibercell Inc., Elpiscience Biopharmaceuticals, KSQ Therapeutics, and Transgene and others.
* Promising Head and Neck Cancer Therapies such as RiMO-301, Pembrolizumab, Dostarlimab, Belrestotug, Nelistotug, Methotrexate, Afatinib, and others.

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Head and Neck Cancer Emerging Drugs Profile

* Petosemtamab: Merus

Petosemtamab, or MCLA-158, is a Biclonics Registered 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-). 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 Trademark 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 Trademark (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).

The Head and Neck Cancer Pipeline Report Provides Insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Head and Neck Cancer with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Head and Neck Cancer Treatment.
* Head and Neck Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Head and Neck Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Head and Neck Cancer Market

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Head and Neck Cancer Companies

Merus, Bicara Therapeutics, Kura Oncology, Inc., Theriva Biologics, Nykode Therapeutics ASA, Cue Biopharma, BioNTech SE, Exelixis, AstraZeneca, Johnson & Johnson, Intragel, AbbVie, IOVANCE Biotherapeutics, Inc., Immutep Limited, Repertoire Immune Medicines, Pyxis Oncology, Inc., ALX Oncology, iTeos Therapeutics, AVEO Oncology, Akeso Biopharma, Coherus BioSciences, Inc., Flamingo Therapeutics, Adlai Nortye Ltd., Hibercell Inc., Elpiscience Biopharmaceuticals, KSQ Therapeutics, and Transgene and others.

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

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

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

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Scope of the Head and Neck Cancer Pipeline Report

* Coverage- Global
* Head and Neck Cancer Companies- Merus, Bicara Therapeutics, Kura Oncology, Inc., Theriva Biologics, Nykode Therapeutics ASA, Cue Biopharma, BioNTech SE, Exelixis, AstraZeneca, Johnson & Johnson, Intragel, AbbVie, IOVANCE Biotherapeutics, Inc., Immutep Limited, Repertoire Immune Medicines, Pyxis Oncology, Inc., ALX Oncology, iTeos Therapeutics, AVEO Oncology, Akeso Biopharma, Coherus BioSciences, Inc., Flamingo Therapeutics, Adlai Nortye Ltd., Hibercell Inc., Elpiscience Biopharmaceuticals, KSQ Therapeutics, and Transgene 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

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Table of Contents

* Introduction
* Executive Summary
* Head and Neck Cancer: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Late Stage Products (Phase III)
* Xevinapant: Debiopharm/Merck
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* Tigilanol tiglate: QBiotics Group Limited
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* MEM-288: Memgen, Inc.
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Head and Neck Cancer Key Companies
* Head and Neck Cancer Key Products
* Head and Neck Cancer - Unmet Needs
* Head and Neck Cancer - Market Drivers and Barriers
* Head and Neck Cancer - Future Perspectives and Conclusion
* Head and Neck Cancer Analyst Views
* Head and Neck Cancer Key Companies
* Appendix

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