US-based biotechnology company Imunon has reported positive results from its Phase II OVATION 2 trial of IMNN-001 for ovarian cancer.
The results showed that when given to women recently diagnosed with advanced ovarian cancer, IMNN-001 demonstrated improvements in various endpoints across treatment groups.
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The therapy was tolerated well and showed a favourable safety profile in the study.
Imunon recently presented the findings at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
The OVATION 2 study enrolled 112 subjects with newly diagnosed advanced epithelial ovarian cancer.
These subjects were randomised to assess the intraperitoneal administration of 100mg/m² of IMNN-001 with neoadjuvant and adjuvant chemotherapy (N/ACT) or the only standard of care (SoC) N/ACT, with a 31-month median follow-up period.
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By GlobalDataAccording to the results, the IMNN-001 treatment arm experienced a median 13-month increase in overall survival (OS) and a median three-month increase in progression-free survival, as well as a mean 6.5-month extension of time free of progression or mortality.
Imunon CEO and president Stacy Lindborg said: “These data highlighting the consistency of results across all treatment groups are a true testament to the power of our TheraPlas technology and the potential of IMNN-001 to transform the treatment paradigm of women who are newly diagnosed with advanced ovarian cancer and in desperate need of new treatment options.
“We are grateful for the continued support and participation of study participants and investigators and look forward to advancing our pivotal Phase III OVATION 3 trial of IMNN-001, with the first two trial sites recently initiated.”
Imunon designed IMNN-001 using its proprietary TheraPlas platform technology.
Earlier this year, the company announced that the US Food and Drug Administration was aligned with its design of the Phase III OVATION 3 trial of IMNN-001 for ovarian cancer.
