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Clinical Trial
. 2025 Jun:197:182-191.
doi: 10.1016/j.ygyno.2025.04.578. Epub 2025 Jun 3.

OVATION-2: A randomized phase I/II study evaluating the safety and efficacy of IMNN-001 (IL-12 gene therapy) with neo/adjuvant chemotherapy in patients newly-diagnosed with advanced epithelial ovarian cancer

Premal H Thaker  1 , Debra L Richardson  2 , Andrea R Hagemann  3 , Robert W Holloway  4 , Mark Reed  5 , Melanie K Bergman  6 , Bhavana Pothuri  7 , Stephen DePasquale  8 , Jennifer M Scalici  9 , Amy J Bregar  10 , Christopher J Darus  11 , Karen Finkelstein  12 , Charles A Leath 3rd  13 , Maria Bell  14 , David P Warshal  15 , Richy Agajanian  16 , Megan D Indermaur  17 , Alberto A Mendivil  18 , Diane M Provencher  19 , Lee-Jen Wei  20 , Nicholas Borys  21 , Lauren Musso  22 , Stacy R Lindborg  23 , Douglas V Faller  24 , Khursheed Anwer  25 , William H Bradley  26
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Free article
Clinical Trial

OVATION-2: A randomized phase I/II study evaluating the safety and efficacy of IMNN-001 (IL-12 gene therapy) with neo/adjuvant chemotherapy in patients newly-diagnosed with advanced epithelial ovarian cancer

Premal H Thaker et al. Gynecol Oncol. 2025 Jun.
Free article

Abstract

Objective: OVATION-2, a randomized, controlled, open label phase 1/2 study, evaluated the safety and efficacy of IMNN-001, an IL-12 immune gene therapy, with neo/adjuvant chemotherapy (N/ACT) compared to N/ACT in newly-diagnosed advanced epithelial ovarian cancer (EOC).

Methods: IMNN-001 is an immunotherapeutic nanoparticle comprising a DNA plasmid encoding the IL-12 gene encased in a lipopolymer. High-grade EOC patients were randomized 1:1 to carboplatin/paclitaxel IV every 21 days for 3 cycles, before and after interval debulking surgery (IDS) or to intraperitoneal (IP) IMNN-001, given weekly concurrently with chemotherapy for 8 weeks before and 9 weeks after IDS.

Results: 54 and 58 patients with predominantly Stage IIIC/IV EOC were evaluated in the control and experimental arm, respectively. Primary endpoints were safety and PFS. Overall, the experimental arm was well tolerated with gastrointestinal and cytopenias as the most common TEAEs with no CRS or elevated risk of immune events. PFS was 14.9 months (mo) for the experimental arm vs 11.9 mo; HR 0.79 (95 % CI: 0.51-1.23). Secondary endpoints included OS (46.0 mo for experimental arm vs 33.0 mo; HR 0.69 (CI: 0.40-1.19)) and surgical response R0 rate (64.6 % experimental arm vs 52.1 %). For patients who received PARPi maintenance, PFS was 33.8 mo vs 22.1 mo; HR 0.80 (CI: 0.31-2.12) and OS was NE vs 37.1 mo with a HR of 0.38 (CI: 0.13-1.06) both favoring the experimental arm.

Conclusion: The addition of IMNN-001 to N/ACT shows a promising numerical 13-mo benefit on survival with an acceptable safety profile in patients with newly-diagnosed advanced EOC.

Keywords: Advanced epithelial ovarian cancer; Gene therapy; IL-12; Immunotherapy.

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Conflict of interest statement

Declaration of competing interest Authors with no competing financial interest or personal relationships that could have appeared to influence the work reported in this paper: Richy Agajanian, Maria Bell, Amy J. Bregar, Megan D. Indermaur, Alberto A. Mendivil, Diane M. Provencher, Jennifer M. Scalici, Mark Reed and David P. Warshal. Karen Finkelstein and Stephen DePasquale have no competing financial interests or personal relationships to influence this work. They are part of the Editorial team of the journal but without any involvement related to this article. Christopher J. Darus is a member of the AstraZeneca Advisory Board. Robert W. Holloway is a member of the AstraZeneca, GSK, Merck, Natera and Caris Speakers' Bureau and receives consultant honoraria from Genelux, GSK and Verastem. Andrea R. Hagemann performs NovoNordisk contracted research work and holds NIH grants. Debra L. Richardson is an Advisory Board member/consultant of GSK, AstraZeneca, Daiichi Sankyo, Genmab, Incyclix, Repare Therapeutics, Immunogen, and a speaker for Zentalis. William H. Bradley and Lee-Jen Wei are consultants for Imunon Inc. Charles A. Leath III performs contracted research for AbbVie, AstraZeneca, Imunon, Merck, Pfizer and Volastra Therapeutics. He has Grants from NIH and is an advisory board member and consultant for AbbVie and Pfizer and a member of the Data Safety Monitoring Board of Imunon Inc. Bhavana Pothuri is a consultant for Abbvie, Beigene, BioNTech, Curio Science, Dualitybio, Loxo, Main Line Health, Onclive, PeerView, OnCust, Pfizer and is a member of the AstraZeneca and Eisai Advisory Boards. Premal H. Thaker has contracts with Merck and GSK, receives support for travel/attending meetings from GSK, participated in the Data Safety Monitoring Board or Advisory Board of Iovance, AstraZeneca, GSK, Zentralis, Novocure, Seagen, Immunogen/Abbvie, Caris, Merck, Versten, Mural Oncology, BioNTech and receives consulting fees and owns stock from Imunon. Nicholas Borys was the former Chief Medical Officer of the initial sponsor of the study and currently an advisor to the current sponsor. Khursheed Anwer, Lauren Musso, Douglas V. Faller and Stacy Linborg are employed by Imunon Inc. SL is the President & CEO of the company and KA is the CSO who also owns company's stock options.

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