Product Description
An immunocytokine of the human monoclonal antibody fragment F16 (scFv) against the extra-domain A1 of tenascin-C fused, via a short 5-amino acid linker, to a recombinant form of the human cytokine interleukin-2 (IL-2) with potential immunostimulating and antineoplastic activities. The monoclonal antibody portion of the F16-IL2 fusion protein binds to tumor cells expressing the tumor associated antigen (TAA) tenascin-C. In turn, the IL-2 moiety of the fusion protein stimulates natural killer (NK) cells, macrophages and neutrophils and induces T-cell antitumor cellular immune responses thereby selectively killing tenascin-C-expressing tumor cells. In addition, F16-IL2 may potentiate the cytotoxicity of other chemotherapeutic agents. Tenascin-C, a glycoprotein of the extracellular matrix, is expressed in many cancer cell types. (Sourced from: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/f16-il2-fusion-protein)
Mechanisms of Action: NK Cells
Novel Mechanism: Yes
Modality: Fusion Protein
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Philogen S.p.A.
Company Location:
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Non-Small-Cell Lung Cancer|Breast Cancer|Carcinoma, Merkel Cell|Melanoma
Phase 1: Acute Myeloid Leukemia
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT02957032 |
PH-F16IL2CYT-03/14 | P1 |
Terminated |
Acute Myeloid Leukemia |
2023-09-29 |
9% |
2023-10-11 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT03207191 |
PHIBI | P1 |
Completed |
Acute Myeloid Leukemia |
2020-03-26 |
2022-04-22 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT05468294 |
Nivokin | P2 |
Unknown status |
Non-Small-Cell Lung Cancer |
2021-12-31 |
25% |
2024-07-03 |
Primary Endpoints |
NCT02054884 |
PH-F16IL2TAXO-03/12 | P2 |
Terminated |
Carcinoma, Merkel Cell |
2016-12-31 |
2021-12-28 |
Primary Endpoints|Treatments |
|
2012-004018-33 |
F16IL2 plus paclitaxel in metastatic Merkel cell carcinoma | P2 |
Terminated |
Carcinoma, Merkel Cell |
2015-04-24 |
2022-03-13 |
Treatments |
|
NCT01134250 |
PH-F16IL2TAXO-05/07 | P2 |
Completed |
Non-Small-Cell Lung Cancer|Melanoma|Breast Cancer |
2014-04-07 |
2022-04-16 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT01131364 |
PH-F16IL2DOXO-04/07 | P2 |
Terminated |
Breast Cancer |
2012-03-01 |
2024-11-27 |
Primary Endpoints|Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/01/2024 |
PubMed |
Clinical advances in TNC delivery vectors and their conjugate agents. |
|
01/01/2024 |
PubMed |
The role of TNC in atherosclerosis and drug development opportunities. |
|
06/28/2022 |
PubMed |
Using stroma-anchoring cytokines to augment ADCC: a phase 1 trial of F16IL2 and BI 836858 for posttransplant AML relapse. |
|
03/26/2021 |
News Article |
Immunocytokines Markets, 2030 |