^
    5ms
    OVATION-3: Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer (clinicaltrials.gov)
    P3, N=500, Recruiting, Imunon | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Lynparza (olaparib) • carboplatin • paclitaxel • Zejula (niraparib) • IMNN-001
    8ms
    OVATION-3: Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer (clinicaltrials.gov)
    P3, N=500, Not yet recruiting, Imunon
    New P3 trial
    |
    Lynparza (olaparib) • carboplatin • paclitaxel • Zejula (niraparib) • IMNN-001
    10ms
    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
    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 completion date: Dec 2024 --> Nov 2025
    Trial completion date • Combination therapy • Metastases
    |
    carboplatin • paclitaxel • IMNN-001
    2years
    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=50, Recruiting, Imunon | Phase classification: P2 --> P1/2
    Phase classification
    |
    Avastin (bevacizumab) • carboplatin • paclitaxel • IMNN-001
    over2years
    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
    |
    GEN1 (GEN1 Holliday junction 5' flap endonuclease)
    |
    carboplatin • paclitaxel • IMNN-001
    over2years
    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
    |
    GEN1 (GEN1 Holliday junction 5' flap endonuclease)
    |
    IMNN-001
    almost3years
    MRD: Phase II GEN-1 on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Imunon
    New P2 trial • Combination therapy • Metastases
    |
    GEN1 (GEN1 Holliday junction 5' flap endonuclease)
    |
    Avastin (bevacizumab) • carboplatin • paclitaxel • IMNN-001
    almost3years
    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
    |
    GEN1 (GEN1 Holliday junction 5' flap endonuclease)
    |
    IMNN-001
    over3years
    Phase Ib trial single-arm efficacy estimates via comparison to a historical clinical trial synthetic control arm (AACR 2022)
    To guide development of the novel immune agent GEN-1, we compared endpoints experienced by patients from a recent neoadjuvant single-arm phase Ib study of GEN-1 plus standard chemotherapy to those of similar historical clinical trial patients in receipt of standard chemotherapy alone. To compare safety and efficacy endpoints following first-line neoadjuvant weekly GEN-1 immunotherapy and carboplatin and paclitaxel to standard first-line neoadjuvant carboplatin and paclitaxel in women with advanced ovarian cancer, we first applied key OVATION-1 trial (NCT02480374) inclusion and exclusion criteria to the Medidata Enterprise Data Store (MEDS) data to identify candidate historical clinical trial patients for comparison. The comparison of patient endpoints from a single-arm phase Ib trial to a historical clinical trial SCA provided informative and relatively reliable estimates of efficacy endpoints which were used to inform GEN-1’s expected effect study size in the phase II setting. This information led to a decrease in the number of planned patients for the subsequent randomized phase II trial. More broadly, this approach supports the ability of historical clinical trial patient comparisons to inform drug development via trial design, something which may further increase the scientific value of early phase trials.
    Clinical • P1 data
    |
    GEN1 (GEN1 Holliday junction 5' flap endonuclease)
    |
    carboplatin • paclitaxel • IMNN-001
    over4years
    GEN-1 in Combination with Neoadjuvant Chemotherapy for Patients with Advanced Epithelial Ovarian Cancer: A Phase I Dose-Escalation Study. (PubMed, Clin Cancer Res)
    Adding GEN-1 to standard NAC is safe, appears active and impacts the tumor microenvironment.
    Clinical • P1 data • Journal • Combination therapy
    |
    IFNG (Interferon, gamma) • GEN1 (GEN1 Holliday junction 5' flap endonuclease)
    |
    carboplatin • paclitaxel • IMNN-001
    over4years
    OVATION II: Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (clinicaltrials.gov)
    P1/2, N=130, Recruiting, Celsion | Trial completion date: May 2024 --> Dec 2024 | Trial primary completion date: Aug 2022 --> Feb 2023
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    GEN1 (GEN1 Holliday junction 5' flap endonuclease)
    |
    carboplatin • paclitaxel • IMNN-001