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Also known as GEN-1
IMNN-001 · 4 trials · 5 indications
Overall Survival is defined as the time (in months) from the date of randomization to the date of death by any cause.
To determine if the addition of IMNN-001 reduces the rate of histologically documented MRD as determined by SLL in the experimental group (chemotherapy + BEV + IMNN-001) as compared to the control group (chemotherapy + BEV).
The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus IMNN-001 versus standard NACT.
Dose-limiting toxicity
| Arm | Type | Description |
|---|---|---|
| Experimental Arm: IMNN-001 + SOC Chemotherapy + SOC Maintenance Therapy | EXPERIMENTAL | IMNN-001 in combination with standard neoadjuvant and adjuvant chemotherapy followed by standard of care maintenance therapy |
| Control Arm: SOC Chemotherapy + SOC Maintenance Therapy | ACTIVE_COMPARATOR | Standard neoadjuvant and adjuvant chemotherapy followed by standard of care maintenance therapy. |
| Chemotherapy + BEV + IMNN-001 (Experimental) | EXPERIMENTAL | Chemotherapy (neoadjuvant and adjuvant): Paclitaxel 175 mg/m2 IV followed by carboplatin AUC 5-6 IV starting on C1D1. During the neoadjuvant period, there will be from 4 to 6 cycles repeated every 21 days. BEV 15 mg/kg IV administration will be included with each cycle except during the cycles around time of surgery. During maintenance, BEV will be administered every 3 weeks as a single agent until disease progression or unacceptable toxicity for a maximum of an additional 18 cycles. In total, BEV may be administered up to 24 cycles. FDA approved BEV biosimilars may be used in this study in place of BEV. IMNN-001 80 mg/m2 IP will be administered weekly beginning C1D15 and continue weekly through the last cycle of adjuvant therapy. At the conclusion of chemotherapy, GEN-1 will be administered every 21 days with BEV in subjects who are BRCA-/HRP until disease progression or unacceptable toxicity for up to an additional 18 cycles. |
| Chemotherapy + BEV (Control) | OTHER | Chemotherapy (neoadjuvant and adjuvant): Paclitaxel 175 mg/m2 IV followed by carboplatin AUC 5-6 IV starting on C1D1. During the neoadjuvant period, there will be from 4 to 6 cycles (at the Investigator's discretion, having an additional C4+1 and C4+2) repeated every 21 days. BEV 15 mg/kg IV administration will be included with each cycle EXCEPT the following cycles: \[1\] Cycle 1, \[2\] the last cycle of neoadjuvant therapy immediately preceding ICS, and \[3\] the first cycle of adjuvant chemotherapy (i.e., first cycle after ICS). During the maintenance phase, BEV 15 mg/kg will be administered every 3 weeks as a single agent until disease progression or unacceptable toxicity for a maximum of an additional 18 cycles. In total, BEV may be administered up to 24 cycles. FDA approved BEV biosimilars may be used in this study in place of BEV. |
| NACT + IMNN-001 | EXPERIMENTAL | The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. IMNN-001 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments. |
| NACT Alone | ACTIVE_COMPARATOR | The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. |
| Single Arm | EXPERIMENTAL | Carboplatin + Paclitaxel + IMNN-001 |
| Name | Type | Description |
|---|---|---|
| IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) | DRUG | 100 mg/m2 IP given weekly during frontline treatment |
| Paclitaxel | DRUG | 175 mg/m2 IV given every 21 days for 6 cycles during frontline treatment |
| Carboplatin | DRUG | AUC 6 IV given every 21 days for 6 cycles during frontline treatment |
| Olaparib | DRUG | Olaparib (300 mg orally every 12 hours for 2 years) for patients with somatic or germline BRCAmut. |
| Niraparib | DRUG | Niraparib (200-300 mg orally daily for 3 years; dosing based on participant's weight and platelet counts) for either HRD/BRCAmut \& HRD/BRCAwt. |
| Bevacizumab | DRUG | BEV 15 mg/kg IV administration will be included with each cycle EXCEPT the following cycles: \[1\] Cycle 1, \[2\] the last cycle of neoadjuvant therapy immediately preceding ICS, and \[3\] the first cycle of adjuvant chemotherapy (i.e., first cycle after ICS). During the maintenance phase, BEV 15 mg/kg will be administered every 3 weeks as a single agent until disease progression or unacceptable toxicity for a maximum of an additional 18 cycles. In total, BEV may be administered up to 24 cycles. FDA approved BEV biosimilars may be used in this study in place of BEV. |
| IMNN-001 | DRUG | IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer |
Inclusion Criteria: 1. Participants must be female, ≥18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent. 2. Participants with a histologically confirmed diagnosis of high-grade non-mucinous epithelial ovarian (serous...
IMNN-001 is an investigational therapy being studied for epithelial ovarian cancer, ovarian cancer, fallopian tube cancer, and primary peritoneal carcinoma. It is given in combination with standard neoadjuvant and adjuvant chemotherapy in newly diagnosed patients with advanced disease. It is not approved for any indication and remains in clinical development.
IMNN-001 is being developed by Imunon, Inc., which trades on the Nasdaq under the ticker IMNN. The company sponsors the clinical program evaluating the agent in ovarian cancer and related peritoneal and fallopian tube cancers.
IMNN-001 is in Phase 3 development. The pivotal study, NCT06915025, is a randomized, active-controlled Phase 3 trial in newly diagnosed patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. IMNN-001 is investigational and has not been approved by the FDA.
IMNN-001 has been studied across several trials. NCT06915025 is a recruiting Phase 3 study with 500 patients. NCT05739981 is a recruiting study of 30 patients. NCT03393884 (OVATION 2) is active but not recruiting with 130 patients, and NCT02480374 is completed with 18 patients.
Yes. IMNN-001 has also been known as GEN-1, and earlier trial records list it under that name. It is described as an IL-12 plasmid formulated with PEG-PEI-cholesterol lipopolymer. Searches for GEN-1 ovarian cancer refer to the same investigational agent now called IMNN-001.
Across the reported studies, total enrollment for IMNN-001 is 648 patients. The Phase 3 trial NCT06915025 accounts for 500 of those, with the remaining patients enrolled in the earlier studies NCT05739981, NCT03393884, and NCT02480374. All trials enrolled patients aged 18 years and older and were limited to female participants.