Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bioferon · 1 trial · 1 indication
Proportion of patients in the safety cohort (chemoimmunotherapy combined with the αDC1 vaccine) experiencing a dose-limiting toxicity (DLT). A DLT will be any adverse event that is at least possibly related to the study treatment and prevents surgery or delays surgery by more than 4 weeks, or that prevents the initiation of the next cycle of treatment on schedule due to toxicity in the prior cycle. The DLT period will be 2 cycles of treatment.
Percentage of patients who show no detectable cancer (cells) in tissue samples after neoadjuvant treatment as assessed at the time of the interval debulking procedure. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in SLD compared to baseline, confirmed on a follow-up scan.
| Arm | Type | Description |
|---|---|---|
| Safety Lead-in: Paclitaxel + Cisplatin + Bioferon + Rintatolimod + Pembrolizomab + Celecoxib | EXPERIMENTAL | - |
| Paclitaxel + Cisplatin + Bioferon + Rintatolimod + DC1 Vaccine + Pembrolizomab + Celecoxib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | A chemotherapy for cancer patients that interferes structures that help move chromosomes during cell division, thus stabilizing these structures to prevents cancer cells from dividing and ultimately causing them to die. Dose: 175 mg/m\^2 IV on D1 each cycle during neoadjuvant and adjuvant periods. |
| Cisplatin | DRUG | An alkylating agent that contains platinum, which binds to DNA in cancer cells, causing cross-links that prevent DNA replication and repair, leading to cell death, particularly in rapidly dividing cancer cells. Dose: 75 mg/m\^2 IP / 1 hour on D1 of each cycle during neoadjuvant and adjuvant treatment periods. |
| Bioferon | DRUG | Inhibits replication of a wide range of RNA and DNA viruses and exerts antiproliferative effects on malignant cells. It suppresses antibody formation through an effect on B-lymphocytes and inhibits onset of delayed hypersensitivity. Dose:6 milli on units/100 mL IP over 30-60 minutes on D2 of each cycle during neoadjuvant and adjuvant treatment. D1 during maintenance treatment periods. |
| Rintatolimod | DRUG | A synthetic double-stranded RNA that selectively activates Toll-like Receptor 3 (TLR3), triggering antiviral and immunomodulatory responses, priming the immune system without causing excessive inflammation. Dose: 200 mg IP over 1-2 hours on D2 of each cycle during the neoadjuvant and adjuvant treatment periods. D1 during maintenance treatment periods |
| αDC1 Vaccine | BIOLOGICAL | Autologous tumor-loaded alpha-DC1 vaccine is the new type of dendritic cell vaccine developed by our group, are the serum-free, clinically-applicable version of type-1 polarized DCs, combining a fully-mature phenotype and high expression of co-stimulatory molecules with an elevated, rather than exhausted, ability to produce IL-12p70. Dose: 6 million dendritic cells (reduced or omitted if insufficient vaccine material), ID injection on rotating sides of lower extremities on D2 each cycle during the neoadjuvant (not C1) and adjuvant treatment periods. D1 of each cycle during maintenance period. |
| Pembrolizumab | DRUG | Humanized monoclonal antibody and a PD-1 inhibitor used in cancer immunotherapy that differs from chemotherapy as it does not directly kill cancer cells but stimulates the immune system, particularly T-cells, to recognize and attack cancer cells more effectively. Dose: 200 mg IV / 30 minutes on D2 of each cycle during neoadjuvant treatment period (none last neoadjuvant cycle), then optional on D2 for adjuvant treatment cycles, and on D1 of maintenance cycles |
| Celecoxib | DRUG | A COX-2 inhibitor in the class of nonsteroidal anti-inflammatory drugs (NSAIDs) that specifically target the cyclooxygenase-2 (COX-2) enzyme, which plays a key role in inflammation Dose: 200mg/day, orally twice a day for days 1-5 and once a day for days 6-21 of neoadjuvant and adjuvant treatment cycles, and then twice a day on D1 and once a day for days 2-21 for maintenance cycles |
| Debulking Procedure | PROCEDURE | A surgical procedure designed to remove the majority of cancerous tumors when complete removal may not be feasible, with the goal of reducing tumor burden, making follow-up treatments like chemotherapy or radiation more effective. Surgery occurs in between the neoadjuvant and adjuvant treatment periods. |
Inclusion Criteria: 1. Patients must have advanced stage (III-IV) epithelial carcinoma or carcinosarcoma of ovarian, tubal or peritoneal origin. a. Histologic documentation of the original primary tumor is required via a pathology report. 2. Patients must be eligible for cancer-related definiti...
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Bioferon is an investigational small molecule being studied for the treatment of ovarian cancer. It is currently in Phase 2 clinical development for this indication. The drug is being evaluated in a clinical trial that combines intensive locoregional chemoimmunotherapy, intradermal autologous alpha-DC1 vaccines, and systemic pembrolizumab for advanced-stage ovarian cancer.
Bioferon is being developed by AIM ImmunoTech Inc., a biopharmaceutical company. The company is conducting a Phase 2 clinical trial of Bioferon for ovarian cancer. AIM ImmunoTech Inc. is the sponsor of the ongoing clinical development program for this investigational drug.
Bioferon is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of ovarian cancer in a Phase 2 clinical trial that is not yet recruiting participants.
Bioferon is being studied in one Phase 2 clinical trial with the identifier NCT07634094. This trial is titled 'Intensive Locoregional Chemoimmunotherapy, Intradermal Autologous Alpha-DC1 Vaccines, and Systemic Pembrolizumab for Advanced-Stage Ovarian Cancer.' The trial is not yet recruiting and has an estimated enrollment of 28 female participants in the United States.
Bioferon is not the same as alpha-DC1 vaccines. In the clinical trial NCT07634094, Bioferon is being studied in combination with intradermal autologous alpha-DC1 vaccines and systemic pembrolizumab. Bioferon is a small molecule, while alpha-DC1 vaccines are a type of cellular immunotherapy. They are distinct components of the treatment regimen being evaluated.