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F16IL2 in combination with paclitaxel
F16IL2 in combination with paclitaxel is a Immunocytokine Small molecule drug developed by Philogen S.p.A.. It is currently in Phase 1 development.
F16IL2 targets tumor vasculature via antibody fragment F16 and delivers IL-2 to stimulate immune response at the tumor site, combined with paclitaxel chemotherapy.
F16IL2 in combination with paclitaxel is being studied in clinical trials for various conditions, including Merkel Cell Carcinoma, Solid Tumor, Breast Cancer, Metastatic Melanoma, and Non-small Cell Lung Cancer (NSCLC). The study, identified as NCT02054884, is a Phase II trial conducted by Philogen S.p.A. to evaluate the efficacy of F16IL2 plus paclitaxel in patients with metastatic Merkel Cell Carcinoma.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | F16IL2 in combination with paclitaxel |
|---|---|
| Sponsor | Philogen S.p.A. |
| Drug class | Immunocytokine |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
F16IL2 is an immunocytokine consisting of the F16 antibody fragment that binds to the A1 domain of tenascin-C, a protein overexpressed in tumor vasculature and stroma, fused to interleukin-2. This targets IL-2-mediated immune activation to the tumor microenvironment. Paclitaxel provides cytotoxic chemotherapy activity.
Approved indications
Common side effects
Key clinical trials
- Combination Therapy of F16IL2 and Paclitaxel in Solid Tumour Patients (PHASE1, PHASE2)
- F16IL2 Plus Paclitaxel in Metastatic Merkel Cell Carcinoma (PHASE2)
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:
- F16IL2 in combination with paclitaxel CI brief — competitive landscape report
- F16IL2 in combination with paclitaxel updates RSS · CI watch RSS
- Philogen S.p.A. portfolio CI
Frequently asked questions about F16IL2 in combination with paclitaxel
What is F16IL2 in combination with paclitaxel?
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Related
- Drug class: All Immunocytokine drugs
- Manufacturer: Philogen S.p.A. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing