Patients
As a company addressing some of the world’s most difficult-to-treat conditions, we see patients as our inspiration and equal partners in our mission to harness the building blocks of life to work in harmony with the body’s immune system.
Our current work with patients is focused on clinical studies of IMNN-001, which targets the micro-environment of ovarian cancer by harnessing the body’s immune system to produce safe and durable levels of a powerful anti-cancer immune agent, IL-12, at the tumor site.
Clinical Studies
IMNN-001 (GEN-1) in ovarian cancer
The 201-24-301 “OVATION 3” study is a randomized phase III study evaluating the safety and efficacy of Intraperitoneal IMNN-001 (formerly known as GEN-1, IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) administered in combination with standard neoadjuvant and adjuvant chemotherapy in newly diagnosed patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. The primary objective is to evaluate if combining IMNN-001 in combination with standard of care chemotherapy followed by standard of care maintenance therapy can improve overall survival in this patient population. This study is now enrolling at select centers throughout the United States of America with additional centers opening up soon. For more information please visit, OVATION 3 Study at clinicaltrials.gov
The 201-21-202 “MRD” study is a Phase II Study evaluating the effect of IMNN-001 (formerly known as GEN-1, IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) on Second Look Laparoscopy (SLL). When administered in combination with Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in subjects newly diagnosed with advanced ovarian, fallopian tube or primary peritoneal cancer. The primary endpoint of the study is to determine if the addition of IMNN-001 can reduce the rate of minimal residual disease (MRD) at SLL from an expected 70% in the control group (chemotherapy + BEV) to 35% in the experimental group (chemotherapy + BEV + IMNN-001). This is a randomized, open lablel, multicenter trial in which eligible subjects will be assigned 1:1 to the treatment and control arms. The study will also evaluate progression free survival and overall survival between the two arms.
OVATION 2 is a Phase I/II study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer. The primary objective of the study is to evaluate safety and compare progression free survival between neoadjuvant chemotherapy (NACT) plus IMNN-001 versus standard NACT. This is a randomized, open label, multicenter trial in which eligible subjects will be assigned 1:1 to the treatment and control arms. The phase II portion has completed and readout results. See more.
OVATION I was a Phase I Study of the Safety & Biological Activity of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Standard Neoadjuvant Chemotherapy in Patients Newly Diagnosed with Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. The primary endpoint was determination of a recommended Phase II dose of IMNN-001 in combination with standard neoadjuvant therapy. It had a standard 3+3 design with approximate 30% dose increments between successive cohorts of patients. The results of OVATION 1 have been published in the journal Clinical Cancer Research.
For Patients
Chapter 1 - Ovarian Cancer Background
Chapter 2 - IMNN-001 Background
Chapter 3 - Ovation 3 Study Information
OVATION 3 Study: A Randomized Phase III Study Evaluating the effect of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) on overall survival.
Administered in Combination with Neoadjuvant and Adjuvant Chemotherapy in Patients Newly Diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.
The OVATION 3 Study (NCT06915025) is a clinical research study to evaluate an investigational drug for the treatment of patients newly diagnosed advanced Ovarian Cancer.
View Trial on Clinical Trials.gov
About the Trial
All eligible patients enrolled in the study will receive the standard treatment for their cancer.
50% will receive standard treatment (neoadjuvant and adjuvant chemotherapy plus interval debulking surgery)
50% will receive a combination of standard treatment and an investigational drug, IMNN-001
Phase III
This Phase III study is the final stage of testing an experimental drug or treatment in human volunteers before it is submitted to regulatory bodies for approval. The volunteer or participant size of this trial is approximately 500 patients. The volunteers need to have the disease or condition the medicine is designed to treat.
Phase III trials take place in hospitals, clinics or physician offices.
Currently enrolling new patients.
Basic Enrollment Criteria Includes:
- Have confirmed or suspected diagnosis of stage III or IV advanced ovarian, fallopian tube or primary peritoneal cancer
- Have not been treated previously
- Have adequate bone marrow, renal, hepatic, and neurological function
- Are free of active infection for 4 weeks prior to treatment
- Have not had any form of cancer in the past 3 years.
A Potential Option Beyond Standard of Care Treatment
Offering the highest standard of care, the potential promise of investigational immunotherapy, and physicians dedicated to patient care and ovarian cancer research.
When speaking with your doctor, have this clinical trial reference number available
US Trial Locations
Locations provided may not reflect the most current site information. Click to access ClinicalTrials.gov site to view study locations.
OVATION 3 Clinical Trial Sites |
City & State |
| Advent Health | Orlando, Florida |
| Erlanger Health | Chattanooga, Tennessee |
| Medical College of Wisconsin | Milwaukee, Wisconsin |
| Providence Cancer Institute | Portland, Oregon |
| Providence Sacred Heart | Spokane, Washington |
| Sanford Health | Sioux Falls, South Dakota |
| Washington University in St. Louis | St. Louis, Missouri |
MRD Study: A Phase II Study Evaluating the effect of IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) on Second Look Laparoscopy (SLL).
Administered in Combination with Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in Subjects Newly Diagnosed with advanced ovarian, fallopian tube or primary peritoneal cancer.
Chapter 1 - Ovarian Cancer Background
Chapter 2 - IMNN-001 Background
Chapter 3 - MRD Study Information
The MRD Study is a clinical research study to evaluate an investigational drug for the treatment of patients newly diagnosed advanced Ovarian Cancer.
View Trial on Clinical Trials.gov
About the Trial
All eligible patients enrolled in the study will receive the standard treatment for their cancer.
50% will receive standard treatment (chemotherapy, BEV and surgery)
50% will receive a combination of standard treatment and an investigational drug, IMNN-001
Phase II
This Phase II study evaluates the safety, efficacy, and biological activity of the medicine in approximately 50 volunteers. Volunteers have the disease or condition the medicine is designed to treat.
Phase II trials take place in hospitals, clinics or physician offices.
Currently enrolling new patients.
Basic Enrollment Criteria Includes:
- Have confirmed or suspected diagnosis of state III or IV high grade serous ovarian, fallopian tube or primary peritoneal cancer
- Have not been treated previously
- Have adequate bone marrow, renal, hepatic, and neurological function
- Are free of active infection for 4 weeks prior to treatment
- Have not had any form of cancer in the past 3 years.
A Potential Option Beyond Standard of Care Treatment
Offering the highest standard of care, the potential promise of investigational immunotherapy, and physicians dedicated to patient care and ovarian cancer research.
When speaking with your doctor, have this clinical trial reference number available
US Trial Locations
Locations provided may not reflect the most current site information. Click to access ClinicalTrials.gov site to view study locations.
MRD Clinical Trial Sites |
City & State |
| MD Anderson Cancer Center | Houston, Texas |
| Memorial Sloan Kettering Cancer Center | New York, New York |
| Sidney Kimmel Comprehensive Cancer Center at John Hopkins | Baltimore, Maryland |
| OU Health, Stephenson Cancer Center | Oklahoma City, Oklahoma |
Resources
Ovarian Cancer Advocacy Programs
Tell Every Amazing Lady About Ovarian Cancer
Louisa M. McGregor Ovarian Cancer offers women’s health and wellness services, including public awareness and education of the signs, symptoms, and risk factors of ovarian cancer, proved support to those impacted by the disease and raises funds for research in order to find a screening test and a cure.
Expanded Patient Access Policy
Patients are our partners, our inspiration, and are behind our commitment to IMUNON’s mission, goals, and development of IMNN-001.
IMUNON believes that participation in one of our clinical trials is the most appropriate way to access our investigational therapies. For more information, visit ClinicalTrials.gov.
At this time, IMUNON is not offering IMNN-001 or any other investigational products under the Expanded Access program.
