Imunon Inc. (NASDAQ:IMNN) on Tuesday reported new preliminary findings from its ongoing Phase 2 minimal residual disease (MRD) translational trial.
MRD refers to the small number of cancer cells that remain in the body during or after treatment.
The data showed that patients receiving IMNN-001 alongside standard-of-care chemotherapy and bevacizumab demonstrated lower rates of residual disease and higher circulating tumor DNA (ctDNA) clearance than those receiving standard treatment alone.
The multi-site study is being led by investigators at The University of Texas MD Anderson Cancer Center, which serves as the lead clinical site.
Researchers are evaluating how IMNN-001 combined with neoadjuvant and adjuvant chemotherapy affects ovarian cancer’s tumor microenvironment and MRD in newly diagnosed advanced ovarian cancer patients.
Early Data Show Improved MRD, ctDNA Outcomes
So far, nine patients in each study arm have reached second-look laparoscopy, the trial’s primary assessment point for surgical MRD. Preliminary results showed that patients treated with IMNN-001 had a lower MRD-positive rate than the control group, at 44% compared with 67%.
The experimental arm also recorded higher ctDNA clearance, with 87.5% of patients clearing circulating tumor DNA versus 62.5% in the control arm.
In addition, all patients receiving IMNN-001 achieved no evidence of disease following frontline therapy, compared with 56% in the control group.
Findings Build On Earlier OVATION 2 Results
The company said the latest MRD data reinforce findings from its completed Phase 2 OVATION 2 study.
In that trial, IMNN-001 was associated with a median overall survival improvement of 14.7 months over chemotherapy alone, extending survival to 45.1 months from 30.4 months.
Among patients who also received PARP inhibitor maintenance therapy, median overall survival increased by 24.2 months, reaching 65.6 months compared with 41.4 months for chemotherapy alone.
Mechanism Of Action And Safety Profile Remain Consistent
According to the company, translational data from the MRD study continue to support IMNN-001’s proposed mechanism of action.
Imunon added that the favorable tolerability profile seen in prior studies has continued in the ongoing MRD trial.
To date, investigators have observed no cytokine release syndrome, systemic toxicities, or serious immune-related adverse events.
IMNN-001 is currently being evaluated in the pivotal Phase 3 OVATION 3 trial enrolling patients with newly diagnosed advanced ovarian cancer across clinical sites in the U.S.
IMNN Price Action: Imunon shares were up 7.91% at $1.91 during premarket trading on Tuesday. The stock is near its 52-week low of $1.70, according to Benzinga Pro data.
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