CD19 Targeted Therapies
9 drugsAbout CD19
CD19 is a cell surface protein expressed on B cells throughout their development. It plays a critical role in B cell receptor signaling and activation. Its consistent presence on B cells makes it a target for therapies aimed at depleting or modifying these cells.
Human genetic studies provide strong validation for CD19 as a therapeutic target (max score 0.84). Loss-of-function variants are associated with increased risk of immunodeficiency, common variable, 3 (score 0.84), suggesting activation may be beneficial.
CD19 is targeted by 4 FDA-approved drugs including MONJUVI, UPLIZNA, BLINCYTO, and ZYNLONTA. These drugs employ various modalities including biologics, bispecific antibodies, and ADCs, primarily for oncology indications.
Strategic Insights
ℹ️ How we calculate- Validated target with strong trial activity and 81% attractiveness score.
- White space opportunity in Recurrent Acute Lymphoblastic Leukemia with only 4 trials.
- phase4 represents biological uncertainty with 33% completion.
CD19 Genetic Evidence Strong
CD19 has strong genetic support with a max score of 0.84 linked to immunodeficiency.
Strong genetic support suggests CD19-targeting therapies have a higher probability of clinical success.
💡 Why activation?
- • Loss-of-function variants increase disease risk (OR > 1) — restoring function may help
- • 100% directional consistency across 2 traits
- • Strong signal in immune system disease, hematologic disease, genetic, familial or congenital disease pathways
Cross-Disease Effects
Trade-off: LowDirection of Effect
100% alignedEvidence Across Diseases
7 totalGWAS and other genetic studies link CD19 to 7 diseases.
Loss-of-function causes disease; activation may help
Loss-of-function causes disease; activation may help
Understanding these scores
Association Score (0-1): Combines all evidence types (genetic, literature, drugs, animal models). Higher = more evidence linking target to disease. This is a ranking heuristic, not a confidence score.
L2G Score: Open Targets uses a machine learning model (Locus-to-Gene) to predict which gene is causal at each GWAS locus. L2G=0.5 means ~50% probability of being the causal gene. Only associations with L2G > 0.05 are included.
Odds Ratio (OR): From gene burden studies (UK Biobank, AstraZeneca PheWAS). Measures how loss-of-function variants affect disease risk. OR<1 = protective (inhibiting target may help), OR>1 = risk (losing function causes disease).
Beta (β): Effect size for continuous traits. β<0 = protective, β>0 = risk.
Clinical Translation (~1.8x): Based on Nelson et al. 2015: drug targets with genetic evidence have ~2x higher success rates in clinical trials. We estimate: Strong support (score ≥0.7) → ~1.8x, Moderate (0.3-0.7) → ~1.3x, Weak → baseline.
Colocalization (H4): Tests whether a GWAS signal and an eQTL/pQTL signal share the same causal variant. H4 is the posterior probability that both traits are associated AND share a causal variant. H4 > 0.8 = strong evidence that gene expression/protein levels drive disease risk. This links genetic variation → gene expression → disease, supporting the target-disease connection.
Top CD19 Drugs
Four companies have approved CD19-targeting drugs, including MORPHOSYS, VIELA BIO, Amgen and ADC Therapeutics.
The presence of four companies indicates a moderately competitive landscape with potential entry barriers.
| Drug | Company | Approved | Indications |
|---|---|---|---|
| MONJUVI | MORPHOSYS US INC | 2020 | 3 |
| UPLIZNA | VIELA BIO | 2020 | 3 |
| BLINCYTO | Amgen | 2014 | 1 |
| Yescarta | Gilead Sciences | 2017 | - |
| Tecartus | Gilead Sciences | 2020 | - |
| Aucatzyl | Autolus, Inc. | 2024 | - |
CD19 Drug Modality Landscape
Modalities
Routes of Administration
CD19 requires biologic approaches (gene therapy), likely due to its structure or location.
Explore novel modalities beyond biologics to differentiate from existing CD19 therapies.
📈 Modality Evolution
Bispecific antibodies pioneered CD19 targeting (2014), with adcs entering more recently (2021).
CD19 Clinical Trials 286 trials
Completion by Phase
| Phase | Total | Completed | Failed | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 83 | 19 | 14 | 48 | 58% |
| Phase 2 | 164 | 37 | 23 | 103 | 62% |
| Phase 3 | 33 | 4 | 2 | 27 | 67% |
| Phase 4 | 6 | 1 | 1 | 4 | 50% |
Top Sponsors
By Modality
Top Conditions
Phase 3 Readout Calendar Pro
5 Phase 3 trials testing approved CD19 drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting CD19. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
CD19 Drug Approval Timeline (2014 - 2024)
the treatment of adult patients with relapsed or refracto...
AUCATZYL is indicated for the treatment of adults with re...
The first CD19-targeting drug was approved in 2014, with the most recent in 2021.
The approval timeline suggests continued interest in CD19, but potential market saturation.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 8 companies competing
- • Market share by company
Full Drug Portfolio
- • All 9 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 9-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Competition: High (15 sponsors)
- • White space: 10 underexplored indications
- • Success rates by condition
Full summary • All drugs • Genetic evidence • Trials • Timeline
How We Calculate These Metrics
Target Attractiveness Score
A 0-100 score based on trial activity, sponsor diversity, and completion rates. Calculated from 228 clinical trials targeting CD19.
Completion rate: Percentage of trials that reached their planned endpoint. Trials terminated early, withdrawn, or suspended are not counted—these often indicate safety issues, lack of efficacy, or strategic pivots.
- Highly Attractive (80+): High trial activity, many sponsors, strong completion rates
- Attractive (60-79): Good trial activity and validation
- Moderate (40-59): Moderate interest from sponsors
- Low (under 40): Limited trial activity or validation concerns
Strategic Insights
Auto-generated insights based on trial analytics including competition intensity, white space opportunities, modality shifts, and failure patterns. We analyze trial sponsors, phases, indications, and outcomes.
Risk Signals
- High Competition: Many sponsors competing for this target (may reduce market opportunity)
- High Failure Risk: Low trial completion rates suggest development challenges
- Low Validation: Limited trial activity or poor outcomes indicate uncertain viability
- White Space Available: Underexplored indications present opportunities