IMNN-001 along with bevacizumab is intended for the treatment of advanced ovarian cancer. Credit: Chinnapong / Shutterstock.

Imunon has started treating the first patient in a Phase I/II clinical trial of IMNN-001, along with bevacizumab in advanced ovarian cancer.

The University of Texas MD Anderson Cancer Center’s Gynecologic Oncology and Reproductive Medicine professor Amir Jazaeri is the principal investigator of the study.

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The study plans to enrol 50 patients with stage III/IV advanced ovarian cancer receiving frontline neoadjuvant therapy.

They will be randomised into a 1:1 ratio to receive either standard chemotherapy plus bevacizumab or chemotherapy plus bevacizumab and IMNN-001.

The detection of minimal residual disease (MRD) by second-look laparoscopy (SLL) is the primary endpoint while progression-free survival is the secondary endpoint of the study.

Initial SLL data are expected within one year and final PFS results are anticipated nearly three years after enrolment concludes.

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In addition, the study will include a wealth of translational endpoints for understanding the clonal evolution along with immunogenomic features of the MRD phase of ovarian cancer.

The Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology will participate in translational analyses.

During this period, trial samples and animal models of ovarian cancer MRD including genomic and biomarker analyses will be used.

IMUNON president and CEO Dr Corinne Le Goff said: “This new trial testing the combination of IMNN-001 and bevacizumab in ovarian cancer starts as we have just announced very encouraging interim data for our OVATION 2 programme evaluating the benefits of IMNN-001 in the neoadjuvant setting.

“We believe the combination of IMNN-001 and bevacizumab holds promise based on findings in our earlier pre-clinical animal studies, where the combination showed strong synergies.

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