Squamous Cell Carcinoma Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, and Companies

DelveInsight's, "Squamous Cell Carcinoma Pipeline Insight 2025" report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in Squamous Cell Carcinoma pipeline landscape. It covers the Squamous Cell Carcinoma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Squamous Cell Carcinoma 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 Squamous Cell Carcinoma Pipeline Report

* On 29 August 2025, Merck Sharp & Dohme LLC initiated a study focused on esophageal squamous cell carcinoma (ESCC) that is either locally advanced and unresectable -meaning it has spread into nearby tissues and cannot be completely removed by surgery-or metastatic , indicating it has spread to other parts of the body.
* On 28 August 2025, Fulgent Pharma LLC announced a FID-007 clinical trial designed to compare the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The trial aims to evaluate efficacy, as well as characterize safety and tolerability. Eligible participants will be enrolled and randomized into one of two arms of FID-007, each combined with a fixed dose of Cetuximab in 28-day cycles.
* On 27 August 2025, Regeneron Pharmaceuticals began a study to evaluate the investigational drug cemiplimab for the treatment of early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by enhancing the immune system's ability to kill cancer cells. It binds to a protein known as programmed cell death-1 (PD-1) found on the surface of specific immune cells.
* On 20 August 2025, Alentis Therapeutics AG initiated a study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of ALE.P02 monotherapy in adult patients with selected squamous solid tumors. The trial also aims to determine the recommended Phase II dose (RP2D).
* DelveInsight's Squamous Cell Carcinoma pipeline report depicts a robust space with 75+ active players working to develop 80+ pipeline therapies for Squamous Cell Carcinoma treatment.
* The leading Squamous Cell Carcinoma Companies such as Hookipa Pharma, Zenith Epigenetics, HiFiBiO, Nanobiotix, GSK, AstraZeneca, VCN Biosciences, Moderna Therapeutics, Exelixis, MacroGenics, Nykode Therapeutics, Tizona Therapeutics, Totus Medicines, Turnstone Biologics, Hoffmann-La Roche, Merus , and others.
* Promising Squamous Cell Carcinoma Therapies such as SI-B001, IFX-1, Afatinib 40 MG, Pembrolizumab Injection, MK-3475A, and others.

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Squamous Cell Carcinoma Emerging Drugs Profile

* NBTXR-3: Nanobiotix

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The drug is currently being evaluated under Phase III clinical trial for the treatment of patients with squamous cell carcinoma.

* mRNA-4157: Moderna Therapeutics

mRNA-4157 is an investigational personalized mRNA cancer vaccine, Merck's anti-PD-1 therapy, for the adjuvant treatment of patients with squamous cell carcinoma. The drug is currently being evaluated under Phase II/III clinical trial for the treatment of patients with squamous cell carcinoma.

* HB-200: Hookipa Pharma

HB-200 is HOOKIPA's lead oncology candidate engineered with the company's proprietary replicating arenaviral vector platform. HB-200 is an alternating 2-vector immunotherapy designed to focus the immune response against the encoded antigen. It comprises two single-vector compounds with arenaviral backbones based on LCMV and PICV. Both encode and express an identical E7E6 fusion protein, comprising well characterized tumor-specific antigens for HPV16+ cancers. The drug is currently being evaluated under Phase II clinical trial for the treatment of patients with squamous cell carcinoma.

* MCLA-158: Merus

MCLA-158 (also known as Petosemtamab) 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). The drug 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 and antibody-dependent cellular phagocytosis activity. The drug is currently being evaluated under Phase I/II clinical trial for the treatment of patients with squamous cell carcinoma.

* HFB-301001: HiFiBiO

HFB301001 is a novel fully human IgG1 class OX-40 agonistic antibody with an optimized pharmacological profile. In contrast to other anti-OX-40 antibodies, the agonistic activity of HFB301001 is further enhanced in the presence of the endogenous ligand OX-40L and does not result in reduced expression of OX-40 on T cells. The drug is currently being evaluated under Phase I clinical trial for the treatment of patients with squamous cell carcinoma.

The Squamous Cell Carcinoma Pipeline Report Provides Insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Squamous Cell Carcinoma 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 Squamous Cell Carcinoma Treatment.
* Squamous Cell Carcinoma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Squamous Cell Carcinoma 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 Squamous Cell Carcinoma market

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Squamous Cell Carcinoma Companies and Therapies

* Sichuan Baili Pharmaceutical Co., Ltd.: SI-B001
* InflaRx GmbH: IFX-1
* Merck Sharp & Dohme LLC: MK-3475A
* ImmunityBio Inc.- Aldoxorubicin HCl
* Incyte Corporation: INCB099280

Squamous Cell Carcinoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

* Intravenous
* Subcutaneous
* Oral
* Intramuscular

Squamous Cell Carcinoma Products have been categorized under various Molecule types such as

* Monoclonal antibody
* Small molecule
* Peptide

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Scope of the Squamous Cell Carcinoma Pipeline Report

* Coverage- Global
* Squamous Cell Carcinoma Companies- Hookipa Pharma, Zenith Epigenetics, HiFiBiO, Nanobiotix, GSK, AstraZeneca, VCN Biosciences, Moderna Therapeutics, Exelixis, MacroGenics, Nykode Therapeutics, Tizona Therapeutics, Totus Medicines, Turnstone Biologics, Hoffmann-La Roche, Merus, and others.
* Squamous Cell Carcinoma Therapies- SI-B001, IFX-1, Afatinib 40 MG, Pembrolizumab Injection, MK-3475A , and others.
* Squamous Cell Carcinoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Squamous Cell Carcinoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Contents

* Introduction
* Executive Summary
* Squamous Cell Carcinoma: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Squamous Cell Carcinoma- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* NBTXR-3: Nanobiotix
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* HB-200: Hookipa Pharma
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* HFB-301001: HiFiBiO
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Squamous Cell Carcinoma Key Companies
* Squamous Cell Carcinoma Key Products
* Squamous Cell Carcinoma- Unmet Needs
* Squamous Cell Carcinoma- Market Drivers and Barriers
* Squamous Cell Carcinoma- Future Perspectives and Conclusion
* Squamous Cell Carcinoma Analyst Views
* Squamous Cell Carcinoma Key Companies
* Appendix

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