CD3 Inhibitors
11 drugsAbout CD3
CD3 is a protein complex essential for T cell activation and adaptive immune response. It functions as a key signaling component within the T cell receptor, initiating downstream effects. As such, CD3 is a crucial regulator of immune function.
CD3 is a therapeutic target with strong genetic support (max score 0.91). Loss-of-function variants in CD3E are associated with immunodeficiency 18 (score 0.91) and severe combined immunodeficiency, suggesting activation of CD3 may be therapeutically beneficial.
CD3 is targeted by 11 FDA-approved drugs, primarily bispecific antibodies (7 drugs) and other biologics (4 drugs). Key drugs include EPKINLY, COLUMVI, and TZIELD, developed by companies like Roche, GENMAB, and PROVENTION BIO, mainly for oncology (9 drugs).
Strategic Insights
ℹ️ How we calculate- Validated target with strong trial activity and 88% attractiveness score.
- White space opportunity in Recurrent Multiple Myeloma with only 5 trials.
Human Genetic Evidence Strong
CD3 has strong genetic support with a max score of 0.91 linked to immunodeficiency.
Strong genetic support suggests that CD3-targeting drugs 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, genetic, familial or congenital disease, phenotype pathways
Cross-Disease Effects
Trade-off: LowDirection of Effect
100% alignedEvidence Across Diseases
5 totalGWAS and other genetic studies link CD3E to 5 diseases.
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 Drugs
Eight companies have approved CD3-targeting drugs, with PROVENTION BIO, Roche, and GENMAB leading the market.
The presence of multiple companies indicates a moderately competitive landscape, but high entry barriers exist due to regulatory hurdles.
| Drug | Company | Approved | Indications |
|---|---|---|---|
| KIMMTRAK | IMMUNOCORE LTD | 2022 | 1 |
| TECVAYLI | Johnson & Johnson | 2022 | 1 |
| LYNOZYFIC | RENGENERON PHARMACEUTICALS, INC. | 2025 | 1 |
| BLINCYTO | Amgen | 2014 | 1 |
| TALVEY | Johnson & Johnson | 2023 | 1 |
| TZIELD | PROVENTION BIO INC | 2022 | 1 |
| IMDELLTRA | Amgen | 2024 | 1 |
| ELREXFIO | Pfizer | 2023 | 1 |
Drug Modality Landscape
Modalities
Routes of Administration
CD3 requires biologic approaches (bispecific antibody), likely due to its structure or location.
The prevalence of bispecific antibodies suggests a competitive market, but opportunities may exist for novel modalities.
📈 Modality Evolution
Bispecific antibodies pioneered CD3 targeting (2014), with other biologics entering more recently (2022).
Clinical Trials 541 trials
Completion by Phase
| Phase | Total | Completed | Failed | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 167 | 42 | 13 | 112 | 76% |
| Phase 2 | 282 | 43 | 20 | 217 | 68% |
| Phase 3 | 77 | 16 | 6 | 55 | 73% |
| Phase 4 | 15 | 2 | 2 | 10 | 50% |
Top Sponsors
By Modality
Top Conditions
Phase 3 Readout Calendar Pro
5 Phase 3 trials testing approved CD3 drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting CD3. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
Drug Approval Timeline (2014 - 2025)
The first CD3-targeting drug was approved in 2014 (BLINCYTO), with the most recent approval in 2025 (LYNOZYFIC).
The continued approval of new drugs indicates an active area of research and development, but potential market saturation should be considered.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 8 companies competing
- • Market share by company
Full Drug Portfolio
- • All 11 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 11-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Competition: High (15 sponsors)
- • White space: 2 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 494 clinical trials targeting CD3.
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