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Cell line and virus
Cell line and virus is a Biologic drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 2 development.
This is a cell line and virus preparation used as a research or therapeutic tool, not a traditional pharmaceutical drug with a defined molecular mechanism.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Cell line and virus |
|---|---|
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Modality | Biologic |
| Phase | Phase 2 |
Mechanism of action
Cell lines and viruses are biological materials used in pharmaceutical development, vaccine production, or research rather than drugs with specific receptor or enzyme targets. Without additional context on the specific cell line type, virus species, or intended use, the mechanism cannot be precisely defined. Phase 2 development suggests this may be a viral vector-based therapy or cell therapy candidate.
Approved indications
Common side effects
Key clinical trials
- A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 (PHASE2, PHASE3)
- Donor-Derived EBV-Specific T Cells for Life Threatening EBV-lymphoma (OLIP-EBV-TCL-01-HMR01) (NA)
- A Study to Evaluate the Safety and Immunogenicity of Two Doses of DCVC H1 HA mRNA-LNP in Healthy Adults (PHASE1)
- A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases (PHASE2)
- Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. (PHASE3)
- Pathological Myeloid Activation After Sepsis and Trauma
- Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC (PHASE2)
- HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cell line and virus CI brief — competitive landscape report
- Cell line and virus updates RSS · CI watch RSS
- Assistance Publique - Hôpitaux de Paris portfolio CI
Frequently asked questions about Cell line and virus
What is Cell line and virus?
How does Cell line and virus work?
Who makes Cell line and virus?
What development phase is Cell line and virus in?
Related
- Manufacturer: Assistance Publique - Hôpitaux de Paris — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing