Imunon has announced the alignment of the US Food and Drug Administration (FDA) with the Phase III OVATION 3 trial of IMNN-001 for ovarian cancer protocol.
IMNN-001, the company’s lead candidate, is being developed for treating women with newly diagnosed advanced ovarian cancer.
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Imunon is initiating sites for the clinical trial and collaborating with investigators to commence participant enrolment.
The study will compare the combo of IMNN-001 100mg/m² with neoadjuvant and adjuvant chemotherapy (NACT) to the standard of care NACT alone in a 1:1 randomisation ratio.
It will consist of women with newly diagnosed stage III or IV advanced ovarian cancer who qualify for neoadjuvant therapy, forming the intent-to-treat (ITT) population.
A subgroup of participants who are positive for homologous recombination deficiency (HRD), which include BReast CAncer gene 1 (BRCA1) or BRCA2 mutations, will be given poly ADP-ribose polymerase (PARP) inhibitors as part of standard maintenance therapy.
Overall survival (OS) is the primary endpoint for the trial, with secondary endpoints including surgical response score, time to second-line treatment, clinical response, and chemotherapy response score.
Several exploratory endpoints will also be evaluated in the trial.
The company noted that the combo demonstrated a median overall survival of 46 months in December 2024, surpassing the standard-of-care NACT by 13 months.
Additionally, Imunon confirmed a positive result from a Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the FDA about the current good manufacturing practice (cGMP) production of the therapy for the trial and commercialisation.
The production is carried out at the company’s in-house manufacturing facility in Alabama, US.
IMNN-001 is developed using the TheraPlas platform technology of the company.
Imunon CEO and president Stacy Lindborg said: “The Phase II 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.
“We look forward to potentially replicating these unprecedented results in the Phase III OVATION 3 study.”
Last month, the company released new immunogenicity and safety data from the ongoing analysis of its proof-of-concept Phase I trial for the IMNN-101 DNA plasmid vaccine.
