Drugs / IMNN-001
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02480374 | Sep 2015 → May 2017 | fallopian tube cancer, malignant epithelial tumor of ovary, peritoneum cancer | Imunon | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05739981 | Feb 2023 → Jun 2027 expected | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Imunon | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03393884 | Sep 2018 → Jul 2024 overdue | fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma | Imunon | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06915025 | Jul 2025 → Oct 2032 expected | fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma | Imunon | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 50
| Date | Issuer | Release |
|---|---|---|
| 2026-09-24 | Imunon | Results IMUNON Makes the Frontline Case for Phase 3 IMNN-001 Study: 14.7-Month OS Signal, Historical IL-12 Safety Barriers Overcome, Enrolling Ahead of Plan imunon.com ↗ |
| 2026-09-22 | Imunon | Results IMUNON Reports Independent Data Monitoring Committee Recommends Continued Phase 2 Development of IMNN-001 Following Favorable Safety Review imunon.com ↗ |
| 2026-08-11 | Imunon | Results IMUNON Reports Second Quarter 2026 Financial Results and Provides Business Update imunon.com ↗
IMNN-001 is the first frontline treatment candidate to demonstrate the potential for a clinically meaningful overall survival benefit in women newly diagnosed with ovarian cancer |
| 2026-07-21 | Imunon | Results IMUNON Reports Positive Phase 2 MRD Clinical Data for IMNN-001, Demonstrating the Successful Overcoming of Historical IL-12 Safety Barriers in Frontline Ovarian Cancer imunon.com ↗ |
| 2026-03-31 | Imunon | Results IMUNON Reports 2025 Financial Results and Provides Business Update Highlighting Significant Progress with Pivotal Phase 3 Study imunon.com ↗
Final Phase 2 clinical data show continued median overall survival improvement with IMNN-001 |
| 2026-03-25 | Imunon | Results IMUNON Reports Updated Phase 2 Data Showing Continued Improvement in Median Overall Survival with IMNN-001 in Women with Newly Diagnosed Advanced Ovarian Cancer imunon.com ↗
The increase in median overall survival among women treated with IMNN-001 in the OVATION 2 trial rose from the previously reported 11.1 months to 14.7 months following final data analysis |
| 2025-11-10 | Imunon | Results IMUNON R&D Day Showcases Clinical Progress of Its Novel Immunotherapy, Phase 3 Trial and Significant Potential for Women with Ovarian Cancer imunon.com ↗
We are very encouraged to see results from our Ovation 2 Study demonstrate that IMNN-001 treatment plus chemotherapy is associated with a 13-month improvement in overall survival with a highly favorable benefit-risk profile. |
| 2025-09-22 | Imunon | Results IMUNON Presents IMNN-001 Phase 2 Translational Data in Advanced Ovarian Cancer Demonstrating 13-Month OS Extension via Tumor Micro-Environment Shift imunon.com ↗
Positive shift in the local TME to favorable immune stimulatory T cell ratios in the majority of participants treated with IMNN-001, including favorable ratios of CD8+/T regulatory (Treg) cells, CD8+/IDO+ cells, and CD8+/CD4+ cells. |
| 2025-06-18 | Imunon | Results IMUNON Presents Positive Phase 2 Translational Data of IMNN-001 in Advanced Ovarian Cancer at ESMO Gynaecological Cancers Congress 2025 imunon.com ↗
Results being presented at the ESMO Congress showed that treatment with IMNN-001 induced substantial increases in IL-12 and interferon-gamma (IFN-γ) and tumor necrosis factor-alpha (TNF-α), key downstream anti-cancer immune cytokines. |
| 2025-06-03 | Imunon | Results IMUNON Announces Data Presented at ASCO Reinforces Unprecedented Overall Survival in Ovarian Cancer Phase 2 Study imunon.com ↗ |
| 2025-05-23 | Imunon | Results IMUNON Announces 2025 ASCO Annual Meeting Oral Presentation Highlighting Unprecedented Survival Data from Phase 2 Trial of IMNN-001 in Treatment of Newly Diagnosed Advanced Ovarian Cancer imunon.com ↗
today announced new positive data from the Company’s Phase 2 OVATION 2 Study of IMNN-001, an investigational therapy for the treatment of advanced ovarian cancer. |
| 2025-03-24 | Imunon | Regulatory IMUNON Finalizes Phase 3 Study Design with FDA for IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer imunon.com ↗ |
| 2025-02-19 | Imunon | Results IMUNON Announces Translational Data from Phase 1/2 OVATION 2 Study of IMNN-001 in Advanced Ovarian Cancer imunon.com ↗
Results demonstrated a 20% increase in IL-12 levels in women treated with IMNN-001 (100 mg/m 2 administered intraperitoneally weekly) plus standard-of-care (SoC) neoadjuvant and adjuvant chemotherapy (NACT) compared to IL-12 levels in women treated with IMNN-001 (79 mg/m 2 ). |
| 2024-12-10 | Imunon | Results IMUNON Announces Continued Strong Improvement in Overall Survival Data from Randomized Phase 2 OVATION 2 Study of IMNN-001 imunon.com ↗
Median OS increased from 11 to 13 months in IMNN-001 treatment group based on latest data analysis |
| 2024-11-07 | Imunon | Results IMUNON Presents Positive Data from Phase 2 OVATION 2 Clinical Trial of IMNN-001 in Advanced Ovarian Cancer at SITC 39th Annual Meeting imunon.com ↗
IMNN-001 immunotherapy plus standard-of-care chemotherapy resulted in 35% improvement in overall survival and 25% improvement in progression-free survival versus standard-of-care alone |
| 2024-07-30 | Imunon | Results IMUNON Announces 11.1 Month Increase in Overall Survival in Patients with Newly Diagnosed, Advanced Ovarian Cancer Treated with IMNN-001 imunon.com ↗
IMUNON, Inc. (NASDAQ: IMNN ), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, announces positive topline results from the Phase 2 OVATION 2 Study with IMNN-001 in patients with advanced ovarian cancer. |
| 2023-09-28 | Imunon | Results IMUNON Reports Interim Progression-Free Survival and Overall Survival Data in Phase 1/2 OVATION 2 Study in Advanced Ovarian Cancer imunon.com ↗
IMUNON , Inc. (NASDAQ: IMNN) , a clinical-stage biotechnology company focused on developing DNA-mediated immunotherapies and next-generation vaccines, announces interim progression-free survival (PFS) and overall survival (OS) data with IMNN-001 in its Phase 1/2 OVATION 2 Study. |
| 2023-04-19 | Imunon | Results IMUNON Presents Poster at the American Association for Cancer Research Annual Meeting Demonstrating Preclinical Immune Response of IMNN-001 imunon.com ↗
There was a gradual rise in tumor burden and mortality in all treatment groups with comparable rates between the once weekly and once every two weeks regimen. |
| 2022-06-21 | Imunon | Results Celsion Reports Data Safety Monitoring Board Unanimous Recommendation to Continue Dosing Patients in the Phase II Portion of the OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer imunon.com ↗
The DSMB also determined that safety is satisfactory with an acceptable risk/benefit, and that weekly doses of GEN-1 were well tolerated during a course of treatment that is given over six months in combination with standard neoadjuvant chemotherapy. |
| 2022-04-14 | Imunon | Results Celsion and Medidata Present Findings on Use of Synthetic Control Arm to Estimate Treatment Effect in Ovarian Cancer Trial at 2022 AACR Annual Meeting imunon.com ↗
This larger than expected effect size led to a decrease in the number of planned patients for Celsion’s subsequent Phase II trial and was used in support of Fast Track Designation from the U.S. Food and Drug Administration (FDA) received in February 2021 . |
| 2022-02-17 | Imunon | Results Celsion Reports Data Safety Monitoring Board Unanimous Recommendation to Continue Dosing Patients in the Phase II Portion of the OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer imunon.com ↗
The DSMB also determined that safety is satisfactory with an acceptable risk/benefit, and that patients tolerate up to 17 doses of GEN-1 during a course of treatment that lasts up to six months. |
| 2021-07-19 | Imunon | Results Celsion Reports Data Safety Monitoring Board Recommendation to Continue Dosing Patients in the Phase II Portion of the OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer imunon.com ↗ |
| 2021-04-01 | Imunon | Results Poster on Celsion Corporation’s Phase I/II OVATION 2 Study Presented at the Society of Gynecologic Oncology Virtual Annual Meeting on Women’s Cancer imunon.com ↗
Company reports further strengthening of R0 resection results in patients treated with GEN-1 |
| 2020-03-26 | Imunon | Results Celsion’s OVATION 1 Study with GEN-1 in Ovarian Cancer Shows Strong Progression-Free Survival Treatment Effect Utilizing Medidata Synthetic Control Arm imunon.com ↗
The hazard ratio (HR) was 0.53 in the intent-to-treat (ITT) group, showing strong signals of efficacy. |
| 2020-03-19 | Imunon | Results Celsion Announces Highly Encouraging Initial Clinical Results from the Phase I Portion of the Phase I/II OVATION 2 Study with GEN-1 in Patients with Advanced Ovarian Cancer imunon.com ↗
GEN-1 plus standard NACT produced positive dose-dependent efficacy results, with no dose-limiting toxicities, which correlates well with successful surgical outcomes as summarized below: |
| 2020-02-06 | Imunon | Results Celsion Corporation Announces DSMB has Confirmed Initial Safety of Weekly GEN-1 Dosing at 100 mg/m² in 15 Randomized Patients with Advanced Ovarian Cancer imunon.com ↗
Celsion Corporation (NASDAQ: CLSN) today announced that the independent Data Safety Monitoring Board (DSMB) has completed its initial safety review of data from the first fifteen patients treated with the first four neoadjuvant doses of GEN-1 at 100 mg/m² in the ongoing Phase I/II OVATION 2 Study. |
| 2019-11-05 | Imunon | Results Celsion Announces DSMB Recommendation to Continue GEN-1 at 100mg/m² Dose to Complete the Phase I Portion of OVATION 2 Study in Ovarian Cancer imunon.com ↗
Based on the DSMB's recommendation, the study will continue as planned and the Company will proceed with completing enrollment in the Phase I portion of the trial. |
| 2019-08-09 | Imunon | Results Celsion's GEN-1 Immunotherapy Highlighted in Oppenheimer's Expert Call on Ovarian Cancer Treatment Landscape and Emerging Opportunities imunon.com ↗
Those data showed that of the 14 evaluable patients, 100% administered NAC plus the two higher doses of GEN-1 experienced an objective tumor response, defined as a partial or complete response. |
| 2019-03-04 | Imunon | Results Celsion Announces GEN-1 Data Presentation at ASCO-SITC Clinical Immuno-Oncology Symposium imunon.com ↗
Also presented were new data from the study demonstrating reduced immunosuppression in the tumor microenvironment (TME) following treatment with GEN-1. |
| 2018-10-24 | Imunon | Results Celsion Announces Progression-Free Survival Data From GEN-1 Phase I Immuno-Oncology Study of Patients with Stage III/IV Ovarian Cancer imunon.com ↗
The results from the OVATION I Study support continued evaluation of GEN-1 based on promising tumor response, as reported in the PFS data, and the ability for surgeons to completely remove visible tumor at debulking surgery. |
| 2018-01-24 | Imunon | Regulatory Celsion Announces FDA Clearance of the OVATION II Study for the Evaluation of GEN-1 Immunotherapy to Treat Newly Diagnosed Stage III/IV Ovarian Cancer imunon.com ↗
Celsion Announces FDA Clearance of the OVATION II Study for the Evaluation of GEN-1 Immunotherapy to Treat Newly Diagnosed Stage III/IV Ovarian Cancer |
| 2017-11-29 | Imunon | Regulatory CORRECTING and REPLACING -- Celsion Files Immunotherapy Clinical Protocol for the Evaluation of GEN-1 to Treat Newly Diagnosed Ovarian Cancer imunon.com ↗
Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced the submission of its Phase I/II clinical trial protocol to the U.S. Food and Drug Administration (FDA) for GEN-1, the Company's DNA-based immunotherapy for the localized treatment of ovarian cancer. |
| 2017-11-29 | Imunon | Results Celsion Updates Clinical Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients imunon.com ↗
Of the five evaluable patients in the first two cohorts who have been on the study for over one year, only one patient's cancer has progressed after 11.7 months. |
| 2017-11-29 | Imunon | Results Celsion Reports Translational Research Data from its Phase 1b Study of GEN-1 Immunotherapy in Recurrent Ovarian Cancer imunon.com ↗
The new data demonstrate that intraperitoneally-administered GEN-1 produces an immunologically distinct IL-12 protein that is localized at the tumor site and lasts for up to one week after a single treatment. |
| 2017-11-29 | Imunon | Results Celsion Presents Two Posters on its GEN-1 IL-12 Gene-Mediated Immunotherapy at the ASCO-SITC Clinical Immuno-Oncology Symposium imunon.com ↗
In the first twelve patients dosed in the OVATION Study, GEN-1 plus standard chemotherapy produced impressive clinical results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. |
| 2017-11-29 | Imunon | Results Celsion Presents GEN-1 Immunotherapy Phase 1b Results in Recurrent Ovarian Cancer at ASCO 2015 imunon.com ↗
The clinical findings demonstrated an overall clinical benefit of 57% for all treatment arms, with a partial response (PR) rate of 21% and a stable disease (SD) rate of 36%. |
| 2017-11-29 | Imunon | Regulatory Celsion Files Immunotherapy Clinical Protocol for the Evaluation of GEN-1 to Treat Newly Diagnosed Ovarian Cancer imunon.com ↗
Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced the submission of its Phase I/II clinical trial protocol to the U.S. Food and Drug Administration (FDA) for GEN-1, the Company's DNA-based immunotherapy for the localized treatment of ovarian cancer. |
| 2017-11-29 | Imunon | Regulatory Celsion Corporation Submits DNA-based Immunotherapy Clinical Protocol to the FDA as Part of a First Line Treatment for Ovarian Cancer imunon.com ↗
today announced the submission of its Phase I clinical trial protocol to the U.S. Food and Drug Administration (FDA) for GEN-1, the Company's DNA-based immunotherapy for the localized treatment of cancer. |
| 2017-11-29 | Imunon | Results Celsion Corporation Presents Clinical and Preclinical Data for GEN-1 IL-12 Immunotherapy in Ovarian Cancer at the Molecular Medicine TRI-Conference imunon.com ↗
today presented clinical and preclinical data demonstrating the safety, biological activity and clinical benefits of GEN-1, its DNA-based immunotherapy, as a single agent in advanced platinum-resistant and recurrent ovarian cancer patients, at the Molecular Medicine TRI-Conference in San Francisco. |
| 2017-11-29 | Imunon | Results Celsion Corporation Highlights Recent Pipeline Developments for its GEN-1 Immunotherapy Program and Provides Business Update imunon.com ↗
Both patients reported stable disease with a dramatic drop in their CA-125 protein levels of 89% and 98%. |
| 2017-11-29 | Imunon | Results Celsion Corporation Announces Positive DSMB Review of Phase 1b OVATION Study in Ovarian Cancer imunon.com ↗
Based on the DSMB's recommendation, the study will continue as planned and the Company will proceed with dosing in its fourth and final patient cohort at an escalated dose. |
| 2017-11-29 | Imunon | Results Celsion Corporation Announces Positive Data from the First Cohort of Patients in the OVATION Study imunon.com ↗
In the first three patients dosed, GEN-1 plus standard chemotherapy produced excellent results, with no dose limiting toxicities and highly promising efficacy signals leading to successful surgical outcomes. |
| 2017-11-29 | Imunon | Results Celsion Announces Presentation of OVATION Study Findings at the ASCO 2017 Annual Meeting imunon.com ↗
At the highest dose, 100% of patients achieved a R0, margin-negative, resection |
| 2017-11-29 | Imunon | Results Celsion Announces Positive Data from the OVATION Study - An Immunotherapy Study of Newly Diagnosed Ovarian Cancer Patients imunon.com ↗
In the first six patients dosed, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. |
| 2017-11-29 | Imunon | Results Celsion Announces Latest Translational Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients imunon.com ↗
The treatment-related changes in immune activating cytokines and pro-tumor VEGF levels followed a dose-dependent trend and were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients' systemic blood stream. |
| 2017-11-29 | Imunon | Results Celsion Announces Impressive Preclinical Data for its GEN-1 IL-12 Immunotherapy in Combination with Avastin® and Doxil® for Ovarian Cancer imunon.com ↗
The findings represent a statistically significant reduction in tumor burden and disease progression when compared to the combination of Avastin® and Doxil® in a SKOV3 human cell line implanted into immunocompromised (nude) mice. |
| 2017-11-29 | Imunon | Results Celsion Announces Final Clinical and Translational Research Data from its OVATION Study at the AACR Special Conference on Ovarian Cancer imunon.com ↗
100% Disease Control; 86% Objective Response Rate and 86% R0 & R1 Surgical Resection Rate in All Patients Treated in Four Dose-Escalating Cohorts |
| 2017-11-29 | Imunon | Results Celsion Announces Continuing Positive Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients imunon.com ↗
In the first twelve patients dosed in the OVATION Study, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. |
| 2017-11-29 | Imunon | Results Celsion Announces Continuing Positive Data from the OVATION Study - An Immunotherapy Study of Newly Diagnosed Stage III and IV Ovarian Cancer Patients imunon.com ↗
In the first nine patients dosed, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. |
| 2017-11-29 | Imunon | Results Celsion Announces Completion of OVATION Study and Provides Update on its Immunotherapy Trial in Advanced Stage III and IV Ovarian Cancer imunon.com ↗
Of the fourteen patients treated to date, two (2) patients demonstrated a complete response, ten (10) patients demonstrated a partial response and two (2) patients demonstrated stable disease, as measured by RECIST criteria. |
All press releases naming this drug 93 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IMNN-001 | “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” NCT05739981 ↗ |
| Known as | GEN-1 | “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” NCT05739981 ↗1“Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)” NCT03393884 ↗ |
| Modality | Other / unclassified | “IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer” NCT02480374 ↗ |
| Route | Other | “intraperitoneal IMNN-001” NCT03393884 ↗ |