CD3 Targeted Therapies
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).
CD3 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 CD3 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 |
|---|---|---|---|
| TZIELD | PROVENTION BIO INC | 2022 | 1 |
| KIMMTRAK | IMMUNOCORE LTD | 2022 | 1 |
| LUNSUMIO | Roche | 2022 | 1 |
| TALVEY | Johnson & Johnson | 2023 | 1 |
| TECVAYLI | Johnson & Johnson | 2022 | 1 |
| IMDELLTRA | Amgen | 2024 | 1 |
| LYNOZYFIC | RENGENERON PHARMACEUTICALS, INC. | 2025 | 1 |
| ELREXFIO | Pfizer | 2023 | 1 |
CD3 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).
CD3 Clinical Trials 527 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on CD3. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 155 | 25 | 13 | 116 | 66% |
| Phase 2 | 294 | 25 | 17 | 250 | 60% |
| Phase 3 | 67 | 3 | 4 | 60 | 43% |
| Phase 4 | 11 | 1 | 1 | 9 | 50% |
Top Sponsors
By Modality
Top Conditions
Phase 3 Readout Calendar Pro
4 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.
CD3 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
- • Sponsors: 210 (34 companies)
- • Completion rates by condition
Full summary • All drugs • Genetic evidence • Trials • Timeline
How We Count Trials
- Trials: phase 1-4 interventional trials on ClinicalTrials.gov that started in 2008 or later and test an FDA-approved drug acting on CD3. A trial counts if an approved drug acting on CD3 is in any arm, including as a comparator, and a trial that tests two such drugs counts once. Trials that test only unapproved drugs are not counted. A trial listed as phase 1/2 counts as phase 1, and phase 2/3 as phase 2.
- Active: recruiting, not yet recruiting, enrolling by invitation, or active and no longer recruiting.
- Completion rate: of the trials that have ended, the share marked Completed rather than Terminated or Withdrawn. Completed means the trial ended as planned; it does not mean the drug worked. Suspended trials are not counted as ended.
- Stopped: terminated or withdrawn. Trials stop for many reasons, including slow enrolment and business decisions, not only safety or efficacy.
- Sponsors: the lead sponsor of each trial. Companies are the sponsors ClinicalTrials.gov classes as industry; the rest are universities, hospitals, cooperative groups, government bodies and individuals.