IMNN-001 / Imunon - LARVOL DELTA

IMUNON Announces Webcast of In-Person R&D Day Highlighting Progress on OVATION 3 Study in Pursuit of First Frontline Immunotherapy for Advanced Ovarian Cancer (GlobeNewswire) - "The investor event will feature ovarian cancer thought leaders, principal investigators from the Company’s Phase 3 OVATION 3 Study and Phase 2 minimal residual disease (MRD) clinical trial, conducted in partnership with Break Through Cancer Foundation, statistical experts and members of IMUNON’s management team, delivering updates on new IMNN-001 data and discussing progress with the OVATION 3 Study and IMNN-001’s potential role in transforming the treatment landscape for women with advanced ovarian cancer."

P3 data • Ovarian Cancer

IMNN-001, IL-12 gene therapy, added to Neo/Adjuvant chemotherapy safely turns the tumor microenvironment cold-to-hot in newly diagnosed epithelial ovarian cancer (EOC) (SITC 2025) - P3 | "Further immunophenotypic analysis will be presented at the Congress.Conclusions IMNN-001induces T cell and myeloid cell mediated anti-tumoral responses across the heterogeneous TMEs characteristic of HGSC, likely driven by the multifaceted actions of IL-12 on both the innate and adaptive immune systems.The ability of IMNN-001 to generate IL-12, IFN-γ and TNF-α locally and the induction of a 'hot' TME collectively support the safety and efficacy observed in the OVATION-2 trial. A Phase III trial (OVATION-3, NCT06915025) is currently enrolling.Trial Registration NCT03393884Ethics Approval This study as part of the translational research of the OVATION-2 trial was approved by all participant clinical sites' Ethics Boards."

Biomarker • Clinical • Gene therapy • IO biomarker • Tumor microenvironment • Epithelial Ovarian Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • CD14 • CD163 • CD20 • CD3E • CD68 • CD8 • FOXP3 • IDO1 • IFNG • IL12A • ITGAM • ITGAX • PD-1 • PD-L1 • PTPRC • TNFA

OVATION-3: A randomized phase III trial evaluating the safety and efficacy of intraperitoneal IL-12 gene therapy administered in combination with standard neoadjuvant and adjuvant chemotherapy (N/ACT) in newly-diagnosed patients with advanced epithelial ovarian cancer (EOC) (ESMO 2025) - P3 | "Trial design 500 patients from approximately 50 sites in Canada and USA will be randomized 1:1 to receive SoC N/ACT with or without IMNN-001, followed by PARPi (olaparib or niraparib) maintenance if homologous recombination-deficient (HRD)...Legal entity responsible for the study Imunon, Inc. Funding Imunon, Inc."

Clinical • Combination therapy • Gene therapy • Metastases • P3 data • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • HRD • IL12A

OVATION-3: A RANDOMIZED PHASE III TRIAL EVALUATING THE SAFETY AND EFFICACY OF INTRAPERITONEAL IL-12 GENE THERAPY ADMINISTERED IN COMBINATION WITH STANDARD NEOADJUVANT AND ADJUVANT CHEMOTHERAPY IN NEWLY DIAGNOSED PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER (IGCS 2025) - P3 | " Patients from ≈50 sites in Canada and USA will be randomized 1:1 to receive SoC N/ACT±IMNN-001, followed by olaparib or niraparib maintenance if HRD...IMNN-001 (100 mg/m2 IP) will be administered weekly through the last CT cycle for a total of 17 treatments. Current Status & Future Directions: The trial will open in May 2025"

Clinical • Combination therapy • Gene therapy • Metastases • P3 data • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • HRD • IL12A

IMUNON to Present Phase 3 OVATION 3 Study of IMNN-001 in Advanced Ovarian Cancer at IGCS 2025 Annual Global Meeting (GlobeNewswire) - "Four sites have been activated to date and are open for patient enrollment, with up to 46 additional sites being considered for activation."

Trial status • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

IMUNON to Present New Translational Data from Phase 2 OVATION 2 Study of IMNN-001 at SITC 40th Annual Meeting (GlobeNewswire)

P2 data • Ovarian Cancer

IMUNON Hosts R&D Day Highlighting Progress on OVATION 3 Study in Pursuit of First Frontline Immunotherapy for Advanced Ovarian Cancer (GlobeNewswire) - "The investor event will feature ovarian cancer thought leaders, principal investigators from the Company’s Phase 3 OVATION 3 Study and Phase 2 minimal residual disease (MRD) clinical trial, conducted in partnership with Break Through Cancer Foundation, statistical experts and members of IMUNON’s management team, delivering updates on new IMNN-001 data and discussing progress with the OVATION 3 Study and IMNN-001’s potential role in transforming the treatment landscape for women with advanced ovarian cancer."

Clinical data • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

IMUNON to Present Phase 3 Ovarian Cancer Study of IMNN-001 at ESMO Congress (GlobeNewswire) - "...Trials-in-progress abstract on the ongoing Phase 3 OVATION 3 clinical trial of IMNN-001, its investigational therapy for the treatment of women with newly diagnosed advanced ovarian cancer, was accepted for poster presentation....The Company...is working with trial investigators to expand clinical sites and accelerate enrollment. Four sites have been activated to date and are open for patient enrollment, with up to 46 additional sites being considered for activation."

Trial status • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

IMUNON to Present New Translational Data of IMNN-001 Supporting Phase 3 Trial of Immunotherapy for Ovarian Cancer at AACR Special Conference in Cancer Research (GlobeNewswire)

P1/2 data • Epithelial Ovarian Cancer

IMUNON Reports Second Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "On July 30, 2025, the Company announced treatment of the first patient in the OVATION 3 Study and is working with trial investigators to expand clinical sites and accelerate enrollment. Three sites have been activated and are open for patient enrollment, with a corporate goal of having 20 sites activated by the end of 2025."

Trial status • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

IMUNON Announces First Patient Dosed in Phase 3 OVATION 3 Study of IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer (GlobeNewswire) - "IMUNON...announced that the first patient has been dosed in the pivotal Phase 3 OVATION 3 Study evaluating the Company’s lead candidate, IMNN-001, for the treatment of women with newly diagnosed advanced ovarian cancer. The first patient was dosed by Melanie K. Bergman, M.D., FACOG, Gynecologic Oncologist with Providence Medical Group at Providence Health in Spokane, Washington....The Phase 3 OVATION 3 trial is designed to assess the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard of care (SoC) N/ACT alone."

Trial status • Ovarian Cancer

OVATION-3: Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Imunon | Not yet recruiting ➔ Recruiting

Enrollment open • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Immune biomarker analysis of the OVATION-2 trial, a randomized phase I/II study of IL-12 gene therapy IMNN-001 in combination with neo/adjuvant chemotherapy (NACT) in newly-diagnosed advanced epithelial ovarian cancer (EOC) (ESMO-GC 2025) - P1/2 | "IMNN-001, a nanoparticle comprising a DNA plasmid encoding the IL-12 gene and a synthetic polymer facilitating plasmid delivery, in combination with carboplatin-paclitaxel chemotherapy, showed numerical survival benefit over SoC in the EOC population...Clinical trial identification NCT03393884. Legal entity responsible for the study Imunon, Inc."

Biomarker • Clinical • Combination therapy • Gene therapy • IO biomarker • Metastases • P1/2 data • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • IFNG • IL12A • TNFA

IMUNON Presents Positive Phase 2 Translational Data of IMNN-001 in Advanced Ovarian Cancer at ESMO Gynaecological Cancers Congress 2025 (GlobeNewswire) - P1/2 | N=130 | OVATION 2 (NCT03393884) | Sponsor: Imunon | "IMUNON...announced the presentation of new positive translational data from the Phase 2 OVATION 2 Study of IMNN-001...for the treatment of newly diagnosed advanced ovarian cancer. Results are being highlighted in a poster presentation at the ESMO Gynaecological Cancers Congress 2025....Results being presented at the ESMO Congress showed that treatment with IMNN-001 induced substantial increases in IL-12 and interferon-gamma (IFN-γ) and tumor necrosis factor-alpha (TNF-α), key downstream anti-cancer immune cytokines. Increases in IL-12, IFN-γ and TNF-α levels in the peritoneal cavity were approximately 27-, 62- and 36-fold following treatment, respectively demonstrating the tumor-localized effect of IMNN-001 in women with advanced ovarian cancer. IMNN-001 continues to show a favorable safety profile."

P2 data • Ovarian Cancer

A phase I/II study of the safety and efficacy of intraperitoneal IMNN-001 in combination with neoadjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian cancer (EOC): Updated survival analysis from OVATION-2 trial. (ASCO 2025) - P1/2 | "IMNN-001 demonstrated trends towards material improvement in overall survival and acceptable safety in advanced EOC, especially in HRD+ patients. These results are supportive of further development in the upcoming pivotal phase 3 study."

Clinical • Combination therapy • Metastases • P1/2 data • Epithelial Ovarian Cancer • Gene Therapies • Oncology • Ovarian Cancer • Pain • Solid Tumor • HRD • IL12A

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. (PubMed, Gynecol Oncol) - "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."

Journal • P1/2 data • Epithelial Ovarian Cancer • Gene Therapies • Hematological Disorders • Oncology • Ovarian Cancer • Solid Tumor • IL12A

IMUNON Announces Data Presented at ASCO Reinforces Unprecedented Overall Survival in Ovarian Cancer Phase 2 Study (GlobeNewswire) - P1/2 | N=130 | OVATION 2 (NCT03393884) | Sponsor: Imunon | "The data being presented today highlight the consistent results achieved across all treatment groups, demonstrating: Median 13-month increase in OS (46 vs. 33 months) and median 3-month increase in PFS (14.9 vs. 11.9 months) in IMNN-001 treatment arm compared to standard of care alone. Better therapeutic effect observed with IMNN-001 treatment compared to the control arm (p=0.0375), as shown by mean 6.5-month extension of time free of progression or death (PFS + OS) captured in totality of treatment effect....Chemotherapy response score highlights double the response rate of a complete or near complete histopathological response following treatment with 26.1% in the IMNN-001 treatment arm compared to 13.0% in the control arm....'We...look forward to advancing our pivotal Phase 3 OVATION 3 trial of IMNN-001, with the first two trial sites recently initiated'."

P2 data • Trial status • Ovarian Cancer

IMUNON Invited to Present Translational Data in Supporting Remarkable Phase 2 Ovarian Cancer Survival Results at ESMO Gynaecological Cancers Congress 2025 (The Manila Times) - "IMUNON, Inc...today announced that an abstract highlighting IMNN-001 data based on an immune biomarker analysis from the Phase 2 OVATION 2 Study in women with newly diagnosed advanced ovarian cancer was accepted for poster presentation at the European Society for Medical Oncology (ESMO) Gynaecological Cancers Congress 2025, being held June 19-21, 2025 in Vienna, Austria."

P2 data • Ovarian Cancer

IMUNON Announces 2025 ASCO Annual Meeting Oral Presentation Highlighting Unprecedented Survival Data from Phase 2 Trial of IMNN-001 in Treatment of Newly Diagnosed Advanced Ovarian Cancer (GlobeNewswire) - P1/2 | N=130 | OVATION 2 (NCT03393884) | Sponsor: Imunon | "IMUNON, Inc...announced new positive data from the Company’s Phase 2 OVATION 2 Study of IMNN-001, an investigational therapy for the treatment of advanced ovarian cancer....Patients in the intent-to-treat (ITT) population administered IMNN-001 plus SoC N/ACT achieved a median increase in overall survival (OS) of 13 months compared to SoC N/ACT alone (46 vs. 33 months), with a hazard ratio of 0.69. Increased therapeutic activity was observed among patients treated with poly ADP-ribose polymerase (PARP) inhibitors as part of standard maintenance therapy, with the median OS not yet reached in the IMNN-001 treatment arm after more than five years (vs. 37 months in the control arm), with a hazard ratio of 0.38."

P1/2 data • Ovarian Cancer

IMUNON Announces First Site Initiated for Pivotal Phase 3 OVATION 3 Study of IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer (GlobeNewswire) - "IMUNON, Inc...today announced that the first trial site has been initiated for the Company’s Phase 3 pivotal study, called OVATION 3, of its lead candidate IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer. The first trial site is Washington University School of Medicine, and IMUNON is currently initiating additional trial sites and working with investigators to begin enrolling study participants....The primary endpoint of the study is overall survival (OS), and secondary endpoints are surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints."

Trial status • Ovarian Cancer

IMUNON Announces Data from Phase 1/2 Trial Evaluating Intraperitoneal IMNN-001 in Combination with Neoadjuvant Chemotherapy in Newly Diagnosed Patients with Advanced Epithelial Ovarian Cancer to be Published in Gynecologic Oncology (GlobeNewswire) - "IMUNON, Inc...today announced that data from the company’s Phase 1/2 OVATION 2 trial evaluating intraperitoneal IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy in newly diagnosed patients with advanced epithelial ovarian cancer will be published in the peer-reviewed journal Gynecologic Oncology."

P1/2 data • Ovarian Cancer

OVATION-3: Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Imunon

New P3 trial • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

IMUNON Announces IMNN-001 Abstract Accepted for Oral Presentation at 2025 ASCO Annual Meeting (GlobeNewswire) - "IMUNON, Inc...today announced that an abstract highlighting new, highly encouraging, Overall Survival data from the Phase 2 OVATION 2 Study of IMNN-001 to treat women with newly diagnosed advanced ovarian cancer was accepted for oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting is being held May 30 - June 3, 2025, in Chicago, Illinois and virtually."

P2 data • Ovarian Cancer

IMUNON Finalizes Phase 3 Study Design with FDA for IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer (GlobeNewswire) - "IMUNON...announced that the U.S. Food and Drug Administration (FDA) is aligned with the protocol for the Phase 3 pivotal trial, called OVATION 3, of its lead candidate IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer. The company is currently initiating trial sites and working with trial investigators to begin enrolling study participants....The Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard of care (SoC) NACT alone."

FDA event • New P3 trial • Ovarian Cancer

IMUNON Reports 2024 Financial Results and Provides Business Update Highlighting Significant Progress Towards the Initiation of a Pivotal Phase 3 Study (GlobeNewswire) - "IMUNON remains on track to initiate the Phase 3 trial in the first quarter of 2025...Research and development (R&D) expenses were $11.6 million for 2024, a decrease of $0.3 million from $11.3 million for 2023. Costs associated with the OVATION 2 Study were $1.4 million and $1.2 million for 2024 and 2023, respectively....Other clinical and regulatory costs, which include start up costs for OVATION 3, were $2.4 million for 2024 compared with $1.8 million for 2023. R&D costs associated with the development of IMNN-001 to support the OVATION 2 Study were $1.8 million for 2024 compared with $1.5 million for 2023."

Commercial • New P3 trial • Ovarian Cancer