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9d
MRD: Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer (clinicaltrials.gov)
P1/2, N=30, Recruiting, Imunon | Trial completion date: Jan 2028 --> Aug 2028 | Trial primary completion date: Aug 2026 --> Dec 2026
Trial completion date • Trial primary completion date
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carboplatin • paclitaxel • IMNN-001
2ms
Potential of IMNN-001 in epithelial ovarian cancer: assessment of clinical findings. (PubMed, Expert Opin Investig Drugs)
IMNN-001 gene therapy could add clinically meaningful IL-12-driven immunotherapy to newly diagnosed ovarian cancer patients. IMNN-001 holds promise for synergistic combinations with immunotherapies requiring intrinsic immune activity.
Review • Journal • IO biomarker
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IFNG (Interferon, gamma)
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IMNN-001
3ms
Enrollment change
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carboplatin • paclitaxel • IMNN-001
10ms
Enrollment open
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Lynparza (olaparib) • carboplatin • paclitaxel • Zejula (niraparib) • IMNN-001
1year
Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2) (clinicaltrials.gov)
P1/2, N=130, Active, not recruiting, Imunon | Trial primary completion date: Dec 2024 --> Jul 2024
Trial primary completion date
|
carboplatin • paclitaxel • IMNN-001
over1year
Study of IMNN-001 (also Known As GEN-1) with NACT for Treatment of Ovarian Cancer (OVATION 2) (clinicaltrials.gov)
P1/2, N=130, Active, not recruiting, Imunon | Trial completion date: Dec 2024 --> Nov 2025
Trial completion date • Combination therapy • Metastases
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carboplatin • paclitaxel • IMNN-001
over2years
Phase classification
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Avastin (bevacizumab) • carboplatin • paclitaxel • IMNN-001
3years
Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (clinicaltrials.gov)
P1/2, N=130, Active, not recruiting, Imunon | Trial primary completion date: Feb 2023 --> Dec 2024
Trial primary completion date • Combination therapy • Metastases
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GEN1 (GEN1 Holliday junction 5' flap endonuclease)
|
carboplatin • paclitaxel • IMNN-001
3years
Efficacy of Gen-1, an interleukin-12 immune gene therapy, at different dose frequencies (AACR 2023)
Once every 2-week dosing of GEN-1 in human studies is warranted. Future combination studies of Gen-1 with immune checkpoint inhibitors will evaluate the safety and efficacy of this regimen.
Clinical • Gene therapy
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GEN1 (GEN1 Holliday junction 5' flap endonuclease)
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IMNN-001
3years
New P2 trial • Combination therapy • Metastases
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GEN1 (GEN1 Holliday junction 5' flap endonuclease)
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Avastin (bevacizumab) • carboplatin • paclitaxel • IMNN-001
over3years
Historic Clinical Trial External Control Arm Provides Actionable GEN-1 Efficacy Estimate Before a Randomized Trial. (PubMed, JCO Clin Cancer Inform)
Comparing results of a single-arm early-phase trial to those of a rigorously matched HCT ECA yielded insights regarding comparative efficacy prior to a randomized controlled trial. The effect size estimate itself informed both the decision to continue development and the randomized phase II trial (ClinicalTrials.gov identifier: NCT03393884) sample size. The work illustrates the potential of HCT data to inform drug development.
Journal
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GEN1 (GEN1 Holliday junction 5' flap endonuclease)
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IMNN-001