IMNN: R&D Day Highlights IMNN-001 Data in Frontline Ovarian Cancer
By David Bautz, PhD
NASDAQ: IMNN
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R&D Day Highlights IMNN-001 in Advanced Ovarian Cancer
On September 23, 2026, Imunon, Inc. (NASDAQ: IMNN) held an R&D Day to discuss the IMNN-001 program, which included a discussion on the use of localized IL-12 in cancer therapy, translational data that showed IMNN-001 is preferentially taken up by macrophages that leads to local IL-12 expression and remodeling of the tumor microenvironment, final data from the OVATION 2 trial that showed median overall survival was 45.1 months with IMNN-001 plus chemotherapy compared to 30.4 months with chemotherapy alone, and an update on the OVATION 3 trial that includes an enrollment rate of approximately 0.5 patients per site per month compared to a 0.3 planning assumption. There was also a pre-recorded conversation that featured a participant from the OVATION 1 trial, who reported she is now almost 10 years from diagnosis and reports remaining free of cancer recurrence.
Resurrecting IL-12: Overcoming Historical Barriers with Targeted TheraPlas™ Delivery of IMNN-001
Dr. Douglas Faller, Imunon’s Chief Medical Officer, provided an overview of IL-12 biology and its role in antitumor biology. Importantly, IL-12 affects both innate and acquired immunity through activation of monocytes, macrophages, dendritic cells, neutrophils, natural killer cells, T cells, and B cells, thus making it a powerful modifier of immune activity.
IL-12 was previously tested as a cancer therapeutic; however, its systemic use was halted following two patient deaths in clinical trials in the late 1990’s. A number of follow-up trials were attempted; however, there was no meaningful benefit noted due to dose-limiting toxicities. Thus, while IL-12 is a very powerful anti-cancer agent, systemic use of the compound isn’t currently possible, and localized delivery is necessary to manage its side effect profile. IMNN-001 has an IL-12 expression vector that is injected into the intraperitoneal cavity where localized expression of IL-12 occurs. This is supported by translational data that shows increased expression of IL-12 along with changes in immune stimulatory and suppression markers from patients treated with IMNN-001 from the Phase 1 and 2 clinical trials, as shown in the following figure.
Dr. Faller also highlighted the consistent safety profile of IMNN-001 that has been seen in clinical trials thus far, which includes no cytokine release syndrome, no serious systemic toxicity, no immune-related adverse events, and two independent safety monitoring committee (IDMC) recommendations to continue the OVATION.3 and Measurable Residual Disease (MRD) study without modification, as there were no safety concerns for either study.
Phase II Randomized Translation Study of Clinical and Biological Changes Induced by IMNN-001 (MRD) Phase in Advanced Stage High Grade Serous Ovarian Cancer
Dr. Amir Jazaeri, the lead principal investigator of the Phase 2 MRD study, presented preliminary clinical and translational findings from the MRD study, in which patients are treated with standard of care chemotherapy and bevacizumab (Avastin ® ) with and without IMNN-001. The primary outcome of the study is MRD as detected by second-look laparoscopy. Thus far, in the intent-to-treat (ITT) population, the MRD positive rate in the IMNN-001 treatment arm (44.4%, 4/9) was lower than the control arm (66.7%, 6/9). In addition, the rate of circulating tumor DNA (ctDNA) clearance was higher in the treatment arm (87.5%, 7/8) than the control arm (62.5%, 5/8). One patient from each cohort did not have ctDNA collection. While the numbers are too small for statistical analysis, there does appear to be a favorable trend in recurrence-free survival (RFS), which is twice as long in the IMNN-001 cohort compared to the control cohort.
Dr. Jazaeri also shared translational data from the study that showed macrophages are the primary cell type that expresses IL-12 following treatment with IMNN-001, along with some expression from cancer-associated fibroblasts (CAF). There was also evidence of localized IL-12 expression causing remodeling of the tumor microenvironment, as shown in the following tumor sample images from three patients on the left. The samples were stained to show the different cell types present in the tumor, with the samples showing infiltration by lymphocytes (light blue) and macrophages (green). The image on the right shows IL-12 expression in relation to the location of the different cell types, with the highest expression of IL-12 seen where macrophages are present.
The MRD study is continuing to enroll patients, and we anticipate the first abstract from the study being presented in 2027.
Advancing Frontline Efficacy: Translating OVATION 2 Overall Survival Signals into Pivotal Phase 3 OVATION 3
Dr. Premal Thaker, the study chair of the OVATION 2 and OVATION 3 studies, presented the final data from the OVATION 2 trial and noted that if replicated in the OVATION 3 trial, IMNN-001 would likely be included in the global standard of care for newly diagnosed, advanced ovarian cancer patients. The following plots show the 14.7-month improvement in median overall survival (mOS) for patients treated with IMNN-001 in the OVATION 2 trial, with those also on PARPi therapy showing an even more dramatic 24.2 month increase in mOS compared to standard of care.
In addition to the positive mOS result, treatment with IMNN-001 showed a consistent positive effect across a number of subgroups and endpoints, as shown in the following image. For example, all subgroup analyses for OS and progression-free survival (PFS) showed results that favored treatment with IMNN-001. This was also true for secondary endpoints such as R0 surgical response, chemotherapy response score, and response rate. This level of consistent signals favoring IMNN-001 provides additional evidence that the results seen in the OVATION 2 trial are meaningful and less likely to be due to random chance.
Dr. Thaker also provided an overview of the OVATION 3 trial, with the study design shown below. Thus far, the trial is off to a strong start, as exemplified by the rapid pace of site activation and patient enrollment. Currently, the study is averaging approximately 0.5 patients per site per month, compared to the industry standard of approximately 0.3 patients per site per month and the 0.2 patients per site per month that were seen in the OVATION 2 trial. We believe this enhanced pace of enrollment is being driven by a combination of factors, including the very promising OS results seen in OVATION 2 along with the biomarker data that supports the mechanism of action for IMNN-001.
Clinical Experience with IMNN-001
Lastly, there was a pre-recorded video interview conducted by Dr. William Bradley, who was a principal investigator in all three OVATION trials, with a patient that participated in the OVATION 1 study. The participant shared her journey from discovering she had ovarian cancer to being treated with IMNN-001 in the OVATION 1 trial to the years that have followed since the study. Notably, she explained that it is now almost 10 years since her initial diagnosis, and she reported remaining free of cancer recurrence.
Conclusion
Imunon’s R&D day provided an in-depth overview of IMNN-001 and its potential in treating front-line advanced ovarian cancer, and we encourage investors to watch the full program, which can be found here . The impressive OS results from OVATION 2, combined with the encouraging safety profile, support the idea that IMNN-001 could become the new standard of care for treating advanced ovarian cancer if the results can be replicated in the OVATION 3 trial. With no changes to our model, our valuation remains at $25 per share.
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