The trial aims to enrol 50 subjects with Stage III/IV ovarian cancer. Credit: Shidlovski / Shutterstock.com.

Imunon has announced the commencement of subject enrolment at Memorial Sloan Kettering Cancer Center in a Phase I/II clinical trial for DNA-based interleukin-12 (IL-12) immunotherapy, IMNN-001, in patients with advanced ovarian cancer.

The trial aims to enrol 50 subjects with Stage III/IV cancer. Those receiving frontline neoadjuvant therapy will be randomised into a 1:1 ratio to receive standard chemotherapy with bevacizumab, versus chemotherapy combined with bevacizumab and IMNN-001.

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Assessing the IMNN-001 combination regimen’s potential in reducing minimal residual disease (MRD) is the primary endpoint of the trial.

Progression-free survival (PFS) is the trial’s secondary endpoint.

Preliminary second-look laparoscopy (SLL) data from the trial are projected to be available within one year after the trial completes enrolment, with final PFS data expected approximately three years post-enrolment.

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The trial will also explore a range of translational endpoints to gain insights into the clonal evolution and immunogenomic characteristics of MRD in ovarian cancer, which currently remains undetectable through imaging or tumour markers.

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The Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology is set to conduct translational analyses on trial samples and animal models, including biomarker and genomic studies.

This is aimed at broadening the understanding of the treatment landscape for ovarian cancer.

IMUNON earlier reported positive safety and promising Phase I data from using IMNN-001 as a monotherapy or in combination with other therapies for advanced ovarian cancer.

The company also concluded the OVATION 1 Study, a Phase Ib dose-escalation trial of IMNN-001 combined with carboplatin and paclitaxel, in newly diagnosed ovarian cancer patients.

IMUNON is currently conducting the Phase II OVATION 2 Study for the localised treatment of advanced ovarian cancer, having announced full enrolment in September 2022.

IMUNON president and CEO Dr Corinne Le Goff said: “We are delighted that such a prestigious institution as Memorial Sloan Kettering has joined this trial, which is testing the combination of IMNN-001 and bevacizumab, known as Avastin, in ovarian cancer.

“We believe this combination therapy holds promise based on our preclinical animal studies, which showed strong synergies between IMNN-001 and bevacizumab.

“As an innovative immunotherapy, IMNN-001 may transform the first-line treatment of ovarian cancer and provide new options to women diagnosed with Stage III/IV disease who face cure rates of 15% or less.”