VivoSeq
Hematology

Cold Agglutinin Disease

13

Pipeline Programs↗

5

Active Trials↗

7

Companies Involved↗

Cold Agglutinin Disease is an emerging landscape with 13 programs across 7 companies. The most active players are BeOne Medicines, Roche, AstraZeneca. 3 programs are in Phase 3.

Intelligence

Pipeline Metrics

Competitive Density

42/100

Pipeline Velocity

0/100

Mech. Concentration

17/100

Completion Rate

91/100

Attrition Rate

6/100

Competition

Competitive Landscape

Bubble size = clinical trials

Approved
Phase 3
Phase 2
Phase 1
Preclinical

Key Players

Top Companies Companies ranked by the number of pipeline programs they run for this disease.

B

BeOne Medicines

1 program

Phase 2Roche logo

Roche

1 program

Phase 2AstraZeneca logo

AstraZeneca

1 program

Phase 2Sanofi logo

Sanofi

3 programs

Phase 2Apellis Pharmaceuticals logo

Apellis Pharmaceuticals

2 programs

Phase 3B

Bioverativ, a Sanofi company

2 programs

Phase 3

Pipeline

Programs by Phase

Analysis

Modality Breakdown

64%

Small molecule

9 of 14 classified programs — the dominant modality here.

36%ALL OTHERSMonoclonal antibody429%Peptide17%

Small molecule leads; the ring shows all 14 classified programs, each share of the total. Modality classified for 100% of 14 pipeline programs.

Analysis

Trial Status

16

clinical trials

Completed10 · 63%
Active, not recruiting3 · 19%
Recruiting2 · 13%
Terminated1 · 6%

Clinical Trials

Trial Activity

16 trials

Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease
Recruiting·GGliknik Inc.·Phase 1·NCT05318534·70 enrolled
Cold Agglutinin Disease Real World Evidence Registry
Recruiting·RRECORDATI GROUP·N/A·NCT05791708·400 enrolled
Zanubrutinib in Primary Cold Agglutinin Disease
Active, not recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 2·NCT06067048·25 enrolled
CARDINAL-LT: Sutimlimab Long-Term in CAD
Active, not recruiting·Sanofi logoSanofi·Phase 3·NCT05900003·130 enrolled
CADENZA-EXT: Sutimlimab in Cold Agglutinin Disease
Active, not recruiting·Sanofi logoSanofi·Phase 3·NCT04762160·78 enrolled
Short Course of Bortezomib in Anemic Patients With Refractory Cold Agglutinin Disease
Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT01696474·21 enrolled
A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)
Completed·BBioverativ, a Sanofi company·Phase 3·NCT03347396·24 enrolled
Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
Completed·Sanofi logoSanofi·Phase 3·NCT05132127·7 enrolled
Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease
Completed·—·Phase 2·NCT02689986·43 enrolled
A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease
Completed·BBioverativ, a Sanofi company·Phase 1·NCT04269551·12 enrolled
Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
Completed·Apellis Pharmaceuticals logoApellis Pharmaceuticals·Phase 2·NCT03226678·24 enrolled
Therapy of Chronic Cold Agglutinin Disease With Eculizumab
Completed·UUniversity Hospital, Essen·Phase 2·NCT01303952·13 enrolled
A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion
Completed·BBioverativ, a Sanofi company·Phase 3·NCT03347422·42 enrolled
A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)
Completed·SSwedish Orphan Biovitrum·Phase 3·NCT05096403·24 enrolled
Therapy for Chronic Cold Agglutinin Disease
Completed·UUniversity of Bergen·Phase 2·NCT00373594·30 enrolled
Page 1 of 2

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