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The phase 3 trial design evaluating IMNN-001 in newly diagnosed advanced ovarian cancer has been finalized among regulatory agencies.
The phase 3 trial design evaluating IMNN-001 in newly diagnosed advanced ovarian cancer has been finalized: © Tada Images - stock.adobe.com
The Food and Drug Administration (FDA), with Imunon Inc., has finalized the study design for the phase 3 OVATION 3 clinical trial evaluating IMNN-001 among patients with newly diagnosed advanced ovarian cancer, according to a pree release from the company.
Moreover, the news release from Imunon also noted that the company is currently initiating trial sites and working with trial investigators to begin the enrollment of participants in the study.
“We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial,” said Stacy Lindborg, president and chief executive officer of Imunon, in the news release. “The Phase 2 OVATION 2 study data are highly encouraging, demonstrating that IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, including benefits in both progression-free and overall survival in frontline treatment, and we continue to observe strong improvements with additional monitoring and follow-up of patients.
Overall survival: the time that a patient lives, regardless of disease status.
Progression-free survival: the time that a patient lives without their disease spreading or worsening.
Neoadjuvant: administered prior to the main treatment, such as surgery.
Adjuvant: administered after the main treatment, such as surgery.
“We look forward to potentially replicating these unprecedented results in the Phase 3 OVATION 3 study. We are currently initiating trial sites and are focused on enrolling study participants as quickly as possible as we work towards our goal of bringing thousands of women with advanced ovarian cancer a first-in-class and much-needed treatment option,” she emphasized.
The OVATION 3 trial is set to analyze the safety and efficacy of IMNN-001 plus neoadjuvant and adjuvant chemotherapy versus standard-of-care chemotherapy alone. Study participants will include those with newly diagnosed staged 3 or 4 ovarian cancer who are eligible for neoadjuvant therapy; a sub-group of participants will include those who are positive for homologous recombination deficiency including BRCA1 or BRCA2 mutations and who will receive poly ADP-ribose polymerase (PARP) inhibitors as part of standard maintenance therapy.
Results from the phase 2 OVATION 2 study — which were announced in 2024 — showed that patients treated with IMNN-001 saw a median increase in overall survival of 11.1 months compared with those who did not receive the new drug, representing a 35% improvement in survival. Additionally, patients who received IMNN-001 alongside standard neoadjuvant chemotherapy experienced a median of three months of improvement in progression-free survival compared with patients who received presurgical chemotherapy alone, a 27% improvement in delaying disease progression.
By December 2024, IMNN-001 plus neoadjuvant chemotherapy had been found to extend overall survival to 46 months, improving on standard-of-care neoadjuvant chemotherapy by 13 months, after seven additional months of follow-up. Additionally, the safety profile showed no cytokine release syndrome or serious side effects, according to the news release.
IMNN-001, touted by Imunon as the first and to date only immunotherapy to show meaningful benefit in a phase 2 trial of patients with advanced ovarian cancer, was described in the company’s press release as an “IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein.”
The IL-12 protein, the company stated, is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation.
IMNN-001 works by instructing the patient’s body to produce safe and durable levels of cancer-fighting molecules at the tumor site, which the company explained in the press release.
In 2025, approximately 20,980 women in the United States will receive a new diagnosis of ovarian cancer, and approximately 12,730 women will die from the disease, according to the American Cancer Society, which stated that ovarian cancer is one of the leading causes of cancer deaths among women. A woman’s risk of getting ovarian cancer, the American Cancer Society stated, is approximately 1 in 91 in her lifetime, while her lifetime chance of dying from the disease is approximately 1 in 143.
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