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Other/HNSCC

HNSCC

20

Pipeline Programs↗

16

Active Trials↗

12

Companies Involved↗

HNSCC is an emerging landscape with 20 programs across 12 companies. The most active players are CSPC Megalith Biopharmaceutical Co.,Ltd., FBD Biologics Limited. 1 program is in Phase 3.

Intelligence

Pipeline Metrics

Competitive Density

50/100

Pipeline Velocity

25/100

Mech. Concentration

40/100

Completion Rate

56/100

Attrition Rate

13/100

Competition

Competitive Landscape

Bubble size = clinical trials

Approved

Phase 3

Phase 2

Phase 1

Preclinical

Key Players

Top Companies

CSPC Megalith Biopharmaceutical Co.,Ltd.

1 program

FBD Biologics Limited

1 program

Pipeline

Programs by Phase

Preclinical5

Tislelizumab

BeiGene

Afatinib

Boehringer Ingelheim

Lysogenic HSV Virus.

West China Hospital

HCB101

FBD Biologics Limited

Pembrolizumab

Merck & Co.

Phase 17

Nivo800

Vanderbilt-Ingram Cancer Center

Nivolumab

Bristol-Myers Squibb

Panitumumab Irdye 800

Vanderbilt-Ingram Cancer Center

Nivolumab-Irdye800

Eben Rosenthal

NRM-823

Normunity AccelCo, Inc.

Phase 27

Dalpiciclib Isethionate

Tianjin Medical University Cancer Institute and Hospital

SYS6002

CSPC Megalith Biopharmaceutical Co.,Ltd.

Ahcccapsules

Shandong University

Dalpicilib Combined With Cetuximab

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Immunotherapy：pembrolizumab；chemo：albumin-Bound Paclitaxel and Cisplatin

Ruijin Hospital

Phase 31

Cisplatin

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Approved

No programs

Analysis

Modality Breakdown

69%

Small molecule

11 of 16 classified programs — the dominant modality here.

Small molecule leads; the ring shows all 16 classified programs, each share of the total. Modality classified for 85% of 20 pipeline programs.

Analysis

Trial Status

30

clinical trials

Recruiting11 · 37%

Completed5 · 17%

Unknown status5 · 17%

Not yet recruiting3 · 10%

Active, not recruiting2 · 7%

Terminated2 · 7%

Other2 · 7%

Clinical Trials

Trial Activity

30 trials

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 2·NCT07668154·120 enrolled

A Phase 1a/1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors

Recruiting·NNormunity AccelCo, Inc.·Phase 1·NCT07182149·150 enrolled

Window Trial of Fluorescently Labeled Panitumumab (Panitumumab-IRDye800) in Head and Neck Cancer

Recruiting·VVanderbilt-Ingram Cancer Center·Phase 1·NCT06819228·70 enrolled

Objective Response Rate of Ivonescimab With Chemotherapy in Locally Advanced Resectable Oral and Oropharyngeal Squamous Cell Carcinoma

Recruiting·ZZhujiang Hospital·N/A·NCT07686575·20 enrolled

Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)

Recruiting·VVanderbilt-Ingram Cancer Center·Phase 1·NCT07460765·40 enrolled

A Phase I/II Trial of HCB101 in Combination With Pembrolizumab for Patients With Platinum-Refractory, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SirH&N Trial)

Recruiting·TTaipei Veterans General Hospital, Taiwan·Preclinical·NCT07136545·50 enrolled

Single-Center Eval of Clinical & Radiological Benefit AHCC in Combo W/ SOC Tx for HPV+ Pts W/ HNSCC

Recruiting·UUniversity of California, Irvine·Phase 2·NCT06693323·34 enrolled

Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in HPV-negative, Anti-PD-1-resistant R/M HNSCC

Recruiting·SShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University·Phase 2·NCT06935188·98 enrolled

Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC

Recruiting·HHunan Cancer Hospital·Phase 2·NCT06752798·30 enrolled

De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC

Recruiting·RRuijin Hospital·Phase 1/2·NCT06572514·20 enrolled

Neoadjuvant SBRT in Localized Advanced HNSCC

Recruiting·—·Phase 2·NCT06306846·81 enrolled

A Prospective, Single-arm Clinical Study of Immune-targeted Therapy Combined With Lysogenic HSV Virus for the Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma

Active, not recruiting·WWest China Hospital·Preclinical·NCT07010120·29 enrolled

Local Injection Methylene Blue Combined With Radiation in HNSCC Patients

Active, not recruiting·—·Phase 1·NCT07435415·10 enrolled

A Prospective, Open-Label, Phase II Clinical Trial of Adebrelimab Combined With Dalpiciclib Isethionate Plus Chemotherapy for Neoadjuvant Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07778732·32 enrolled

Window Trial of Intratumoral (IT) Neoadjuvant Fluorescently Labelled Nivolumab (nivo800) in Head and Neck Squamous Cell Carcinoma (HNSCC)

Not yet recruiting·VVanderbilt-Ingram Cancer Center·Phase 1·NCT07741565·18 enrolled

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Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)