Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VCN-01 · 3 trials · 6 indications
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | ACTIVE_COMPARATOR | Single dose of 3.3x10(12) vp of VCN-01 on Day 0, followed by a single dose of 5x10(7) of huCART-meso cells on Day 14. |
| Cohort 2 | ACTIVE_COMPARATOR | Single dose of 1x10(13) vp of VCN-01 on Day 0, followed by a single dose of 5x10(7) of huCART-meso cells on Day 14. |
| Cohort -1 | ACTIVE_COMPARATOR | In the event that 2 DLTs occur in Cohort 1, then enrollment in Cohort 1 will be stopped and Cohort -1 will be opened for evaluation. Enrolled subjects will receive a single dose of huCART-meso cells on Day 0 followed by a single dose of 3.3x10(12) vp of VCN-01 on Day 14. |
| Dose Escalation, Combination | EXPERIMENTAL | Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine. |
| Part I: Dose Escalation, Single Agent | EXPERIMENTAL | Single intravenous injection of VCN-01 oncolytic adenovirus |
| Part II: Dose Escalation, Combination | EXPERIMENTAL | Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine |
| Part III: Dose Escalation, Combination, "delayed" schedule | EXPERIMENTAL | Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine |
| Name | Type | Description |
|---|---|---|
| VCN-01 | BIOLOGICAL | Intravenous administration of VCN-01 |
| huCART-meso Cells | BIOLOGICAL | Intravenous administration of huCART-meso cells |
| Gemcitabine | DRUG | 1000 mg/m2 intravenous administration |
| Abraxane® | DRUG | 125 mg/m2 intravenous administration |
Inclusion Criteria: 1. Patients with one of the following diagnoses: 1. Histologically confirmed unresectable or metastatic pancreatic adenocarcinoma; OR 2. Persistent or recurrent serous epithelial ovarian cancer 2. Progression or intolerance to at least one prior standard of care chemother...
Top 20 of 71 competitors
VCN-01 is an investigational gene therapy being developed for oncology indications, including pancreatic cancer, locally advanced solid tumors, and pancreatic adenocarcinoma. It is currently in Phase 1 clinical development and has not been approved by the FDA.
VCN-01 is a gene therapy designed to target cancer cells. It is being studied as a treatment for pancreatic cancer and other solid tumors. The therapy is administered either intratumorally or intravenously, often in combination with chemotherapy agents such as gemcitabine and nab-paclitaxel.
VCN-01 is being developed by Theriva Biologics, Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol TOVX. The company is conducting clinical trials to evaluate the safety and efficacy of VCN-01 in patients with advanced solid tumors.
VCN-01 is currently in Phase 1 clinical development. It has received Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the FDA, but it remains investigational and is not yet approved for any indication.
VCN-01 has been studied in three Phase 1 trials. NCT02045589 evaluated intratumoral VCN-01 with gemcitabine and Abraxane in advanced pancreatic cancer. NCT02045602 tested intravenous VCN-01 with or without gemcitabine and Abraxane in advanced solid tumors. NCT05057715 is an active trial combining huCART-meso and VCN-01 in pancreatic and ovarian cancer.
No, VCN-01 is not the same as huCART-meso. VCN-01 is a gene therapy developed by Theriva Biologics, while huCART-meso is a chimeric antigen receptor T-cell therapy. They are being studied in combination in a Phase 1 trial for pancreatic and ovarian cancer.