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Oncology/Triple Negative Breast Cancer (TNBC)

Triple Negative Breast Cancer (TNBC)

13

Pipeline Programs↗

12

Active Trials↗

9

Companies Involved↗

Triple Negative Breast Cancer (TNBC) is an emerging landscape with 13 programs across 9 companies. The most active players are Sichuan Baili Pharmaceutical Co., Ltd.. 2 programs are in Phase 3.

Intelligence

Pipeline Metrics

Competitive Density

45/100

Pipeline Velocity

37/100

Mech. Concentration

25/100

Completion Rate

50/100

Attrition Rate

7/100

Competition

Competitive Landscape

Bubble size = clinical trials

Approved

Phase 3

Phase 2

Phase 1

Preclinical

Key Players

Top Companies

Sichuan Baili Pharmaceutical Co., Ltd.

1 program

Pipeline

Programs by Phase

Preclinical5

Zn-Telomir

Telomir Pharmaceuticals, Inc.

Group 1-Isunakinra

University Health Network, Toronto

Breakvax

BreakBio Corp

Ipilimumab

Bristol-Myers Squibb

Losartan

Organon and Co

Phase 11

Ct-202

Context Therapeutics Inc.

Phase 25

Pembrolizumab

Merck & Co.

Carboplatin

Avyxa

Retlirafusp Alfa

Tang-Du Hospital

Paclitaxel

Teva

Paclitaxcel

Shanghai Jiao Tong University School of Medicine

Phase 32

BL-B01D1

Sichuan Baili Pharmaceutical Co., Ltd.

PD-1 Monoclonal Antibody

Sichuan Baili Pharmaceutical Co., Ltd.

Approved

No programs

Analysis

Modality Breakdown

63%

Small molecule

5 of 8 classified programs — the dominant modality here.

Small molecule leads; the ring shows all 8 classified programs, each share of the total. Modality classified for 62% of 13 pipeline programs.

Analysis

Trial Status

14

clinical trials

Not yet recruiting6 · 43%

Recruiting5 · 36%

Terminated1 · 7%

Enrolling by invitation1 · 7%

Completed1 · 7%

Clinical Trials

Trial Activity

14 trials

Pilot Feasibility Trial of a Nurse-Led, Coping and Supportive Intervention (RESTORE) for Patients With Triple-Negative Breast Cancer

Recruiting·MMassachusetts General Hospital·Preclinical·NCT07513311·75 enrolled

A Phase 1, Multicenter, Open-label, First-in-Human Study of ITI-5000 (Self-Amplifying RNA Vaccine) Alone and in Combination With Standard of Care Adjuvant Therapy in Participants With Stage II-III Triple-Negative Breast Cancer (TNBC)

Recruiting·IImmunomic Therapeutics, Inc.·Phase 1·NCT07652242·60 enrolled

A Phase 1a/1b, First Time in Human Study of CT-202, A Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, and Urothelial Cancers

Recruiting·CContext Therapeutics Inc.·Phase 1·NCT07545122·162 enrolled

NeoTILs: A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early-Stage Triple Negative Breast Cancer (TNBC) Patients With High Tumor-Infiltrating Lymphocytes (TILs)

Recruiting·MMedical University of South Carolina·Phase 2·NCT07743190·55 enrolled

Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer

Recruiting·CCenter Eugene Marquis·N/A·NCT07570524·200 enrolled

A Phase 2 Randomized Pilot Study to Develop Tailored Neoadjuvant Chemoimmunotherapy Strategies in Stage I Triple-negative Breast Cancer (DETENTE-1)

Not yet recruiting·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT07786428·60 enrolled

A Phase III Randomized Controlled Clinical Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07729956·436 enrolled

Phase 1/2 Trial of a Combination Immunotherapy Treatment for Solid Tumors Including BreakVax ImmunoTreatment (Designed and Manufactured Per Patient), Chemotherapy and Anti PD-1 Therapy

Not yet recruiting·BBreakBio Corp·Preclinical·NCT07762703·10 enrolled

Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer: An Exploratory Clinical Study

Not yet recruiting·HHarbin Medical University·Phase 2·NCT07752550·120 enrolled

Rebooting Sensitivity to Checkpoint Blockade Therapy in Triple-Negative Breast Cancer With Isunakinra (RESETT- I)

Not yet recruiting·UUniversity Health Network, Toronto·Preclinical·NCT07698106·60 enrolled

A First-in-Human (FIH), Phase I/II, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Antitumor Activity of Zn-Telomir Administered Orally as Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)

Not yet recruiting·TTelomir Pharmaceuticals, Inc.·Preclinical·NCT07581314·76 enrolled

Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer（UPGRADE-TNBC）

Enrolling by invitation·CCancer Institute and Hospital, Chinese Academy of Medical Sciences·Preclinical·NCT06910072·32 enrolled

Survival Outcomes of Residual Disease in Patients With Triple-Negative Breast Cancer Following Neoadjuvant Therapy: A Retrospective Cohort Study

Completed·SSohag University·N/A·NCT07714382·100 enrolled

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination With Select Targeted Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Oncogene Amplifications

Terminated·BBoundless Bio, Inc.·Phase 1·NCT05827614·85 enrolled

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