Core Insights - IMUNON, Inc. is presenting updates on its IMNN-001 development program for newly diagnosed advanced ovarian cancer, highlighting positive data from the Phase 2 OVATION 2 Study and ongoing Phase 3 OVATION 3 trial [1][2][8] Group 1: IMNN-001 Development Program - IMNN-001 is a DNA-mediated immunotherapy that has shown a 13-month improvement in overall survival when combined with standard chemotherapy, marking a significant advancement in ovarian cancer treatment [2][5] - The Phase 2 OVATION 2 Study demonstrated a favorable benefit-risk profile for IMNN-001, with results indicating a broad impact on cancer-fighting cytokines and a shift in the tumor microenvironment from "cold" to "hot" [5][6] - The ongoing Phase 3 OVATION 3 trial is designed with an innovative, adaptive approach that aligns with successful oncology trials, increasing the probability of success [4][6] Group 2: Clinical Insights and Expert Opinions - Experts at the event will discuss the unmet needs in ovarian cancer treatment, emphasizing that patient outcomes have not significantly changed in the last 30 years, and the promise that IMNN-001 holds for patients [5] - New translational data from the Phase 2 MRD study indicates that IMNN-001 is preferentially taken up by macrophages, leading to a robust immune response and tumor microenvironment remodeling [5][6] - The safety and tolerability of IMNN-001 have been positively evaluated, including its combination with standard chemotherapy and in maintenance settings [5][6] Group 3: Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases [7] - The company is advancing its non-viral DNA technology, with IMNN-001 being the lead clinical program aimed at treating advanced ovarian cancer [8] - IMUNON is also developing a COVID-19 booster vaccine, showcasing its commitment to leveraging its technological capabilities for patient benefit [8]

Core Insights - IMUNON, Inc. is hosting an R&D Day on November 10, 2025, to discuss its DNA-mediated immunotherapy, IMNN-001, which is in Phase 3 development for advanced ovarian cancer treatment [1][2] - The event will feature presentations from leading investigators involved in the clinical trials, highlighting the urgent need for new treatment options in ovarian cancer [2][7] - IMUNON aims to bring innovation to ovarian cancer treatment, which has not seen significant advancements in approximately 30 years [2] Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases [4] - The company is advancing its non-viral DNA technology, with its lead clinical program, IMNN-001, being a DNA-based immunotherapy for advanced ovarian cancer [5] - IMNN-001 instructs the body to produce cancer-fighting molecules at the tumor site and has completed multiple clinical trials, including a Phase 2 trial and is currently in a Phase 3 trial [5] Clinical Trials and Research - The OVATION 2 trial data presented will include survival benefits and address the unmet needs in ovarian cancer treatment [7] - The Phase 2 minimal residual disease (MRD) study results will provide insights into immune activation mechanisms [7] - The statistical design of the Phase 3 trial and the path to approval will be discussed, along with enrollment momentum and clinical milestones [7]

Core Points - IMUNON, Inc. is a clinical-stage biotechnology company focused on DNA-mediated immunotherapy, currently in Phase 3 development with its lead product, IMNN-001, for advanced ovarian cancer [1][5] - The company will host a conference call on November 13, 2025, to discuss its third-quarter financial results and provide updates on its clinical development programs [1][2] Company Overview - IMUNON is advancing innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases, differentiating itself from conventional therapies [4] - The company is developing non-viral DNA technology, with two main modalities: TheraPlas for gene-based delivery of cytokines in solid tumors, and PlaCCine for gene delivery of viral antigens [4] Clinical Development - IMNN-001 is designed for localized treatment of advanced ovarian cancer and has completed multiple clinical trials, including a Phase 2 trial (OVATION 2) and is currently in a Phase 3 trial (OVATION 3) [5] - The therapy instructs the body to produce cancer-fighting molecules like interleukin-12 and interferon gamma at the tumor site [5] - The company has also completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101) [5]

Core Insights - IMUNON, Inc. is hosting an R&D Day for investors on November 10, 2025, in New York City to provide updates on its Phase 3 study of IMNN-001, a DNA-mediated immunotherapy for advanced ovarian cancer [1][2] Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases [5] - The company is developing non-viral DNA technology, with its lead clinical program, IMNN-001, aimed at localized treatment of advanced ovarian cancer [6] Clinical Trials and Research - IMNN-001 has completed multiple clinical trials, including a Phase 2 trial (OVATION 2) and is currently in a Phase 3 trial (OVATION 3) [6] - The upcoming investor event will feature presentations from thought leaders and principal investigators discussing new data on IMNN-001 and its potential impact on ovarian cancer treatment [2][7] Event Details - The event will include a live Q&A session and networking opportunities with speakers and IMUNON management, enhancing engagement with investors [2][4]

Core Insights - IMUNON, Inc. has been invited to present its ongoing Phase 3 OVATION 3 clinical trial of IMNN-001 at the IGCS and ESMO Congress 2025, highlighting the therapy's potential in treating advanced ovarian cancer [1][3] Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using its proprietary TheraPlas technology platform, which enables gene-based delivery of therapeutic proteins [10][11] - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, having completed multiple clinical trials including a Phase 2 trial [11] Clinical Trial Details - The OVATION 3 study is a pivotal Phase 3 trial evaluating the safety and efficacy of IMNN-001 in combination with standard chemotherapy for newly diagnosed advanced ovarian cancer patients [4][5] - The trial has shown promising results from the Phase 2 OVATION 2 study, with a median overall survival (OS) increase of 13 months and a median progression-free survival (PFS) increase of 3 months compared to standard care [5][7] - The study design includes two planned interim analyses and aims for at least 95% statistical power on the primary endpoint of overall survival [5] Treatment Mechanism - IMNN-001 utilizes an interleukin-12 (IL-12) DNA plasmid vector in a nanoparticle delivery system, promoting local production of IL-12 in the tumor microenvironment, which is crucial for inducing anticancer immunity [2][8] - The therapy has demonstrated a significant therapeutic effect, with a hazard ratio (HR) of 0.70 for OS and 0.79 for PFS compared to standard care [5] Market Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases annually in the U.S., and a high recurrence rate post-treatment [9] - There is a critical need for therapies that improve overall survival and reduce recurrence rates in patients diagnosed with advanced stages of the disease [9]

Core Insights - IMUNON, Inc. is advancing its IMNN-001 program, currently in the OVATION 3 pivotal Phase 3 trial for advanced ovarian cancer, with new data from the Phase 2 OVATION 2 trial to be presented at the SITC Annual Meeting [1][3] Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments that utilize the body's natural mechanisms for effective responses against various diseases [10][11] - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, having completed multiple clinical trials including the Phase 2 OVATION 2 and currently conducting the Phase 3 OVATION 3 trial [11] IMNN-001 Therapy Details - IMNN-001 is based on IMUNON's TheraPlas® technology, utilizing an IL-12 DNA plasmid vector in a nanoparticle delivery system to induce strong anti-cancer immunity [2][8] - The therapy has shown clinically effective responses in advanced ovarian cancer, improving both progression-free survival (PFS) and overall survival (OS) when combined with standard chemotherapy [2][4] Clinical Trial Insights - The OVATION 3 trial is designed with at least 95% statistical power for the primary endpoint of overall survival, including two planned interim analyses for potential accelerated FDA submission [5][6] - The OVATION 2 study demonstrated a median OS increase of 13 months and a median PFS increase of 3 months for the IMNN-001 treatment arm compared to standard care [5][7] Presentation and Data Sharing - Positive translational data from the OVATION 2 study was previously presented at the AACR Special Conference, highlighting the safety profile and efficacy of IMNN-001 [3][4] - The upcoming SITC presentation will focus on how IMNN-001 can convert the tumor microenvironment from "cold" to "hot," enhancing immune response in newly diagnosed epithelial ovarian cancer [3]

Core Insights - IMUNON, Inc. will host an R&D Day for investors on November 10, 2025, in New York City to provide updates on its pivotal Phase 3 study of IMNN-001, a DNA-mediated immunotherapy for advanced ovarian cancer [1][2] Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases, differentiating itself from conventional therapies [4] - The company is developing non-viral DNA technology, with its first modality, TheraPlas, aimed at gene-based delivery of cytokines for solid tumors, and the second modality, PlaCCine, for gene delivery of viral antigens [4] Clinical Programs - The lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, currently in Phase 3 clinical trial (OVATION 3) after completing a Phase 2 trial (OVATION 2) [5] - IMNN-001 instructs the body to produce cancer-fighting molecules at the tumor site, aiming to provide safe and durable treatment outcomes [5] Event Details - The investor event will feature presentations from ovarian cancer experts, principal investigators from the OVATION 3 study, and statistical experts, discussing new data on IMNN-001 and its potential impact on ovarian cancer treatment [2][3] - A live Q&A session and networking opportunities will follow the formal presentations, allowing attendees to engage with speakers and IMUNON management [2] Featured Presentations - Presentations will include topics such as the potential of IMNN-001 to transform the microtumor environment, safety and tolerability insights, and statistical properties of the Phase 3 trial design [6]

Core Insights - IMUNON, Inc. is advancing its investigational DNA plasmid vaccine, IMNN-101, based on its proprietary PlaCCine technology platform, with upcoming presentations at major vaccine conferences [1][2][3] Group 1: Clinical Developments - IMUNON announced positive six-month data from the Phase 1 trial of IMNN-101, showing proof of concept for the PlaCCine technology, with better durability of protection compared to mRNA vaccines after a single dose targeting the SARS-CoV-2 Omicron XBB1.5 spike antigen variant [2] - IMNN-101 induced up to a 3-fold median increase in serum neutralizing antibody titers from baseline at six months, with stronger immune responses observed in higher dose cohorts [2] - The vaccine was reported to be safe and well tolerated, with no serious adverse effects noted [2] Group 2: Strategic Partnerships - To accelerate the development and commercialization of the PlaCCine platform, IMUNON is actively seeking strategic partnerships with leading pharmaceutical and biotechnology companies [3] - These collaborations aim to leverage PlaCCine's advantages, including enhanced durability, temperature stability, and scalable manufacturing, to address unmet needs in vaccines for infectious diseases and cancer [3] Group 3: Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments that utilize the body's natural mechanisms for safe and effective responses across various diseases [4] - The company is developing non-viral DNA technology, with its first modality, TheraPlas, aimed at gene-based delivery of cytokines for solid tumors, and the second modality, PlaCCine, for gene delivery of viral antigens [4] - IMUNON's lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, currently in Phase 3 clinical trials [5]

Core Insights - IMUNON, Inc. is advancing its pivotal Phase 3 OVATION 3 trial for IMNN-001, a DNA-mediated immunotherapy targeting newly diagnosed advanced ovarian cancer, with a poster presentation accepted at the ESMO Congress 2025 [1][2][5] Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments utilizing non-viral DNA technology, specifically the TheraPlas® platform for gene-based delivery of cytokines [11][12] Product Details - IMNN-001 is an IL-12 DNA plasmid vector designed to induce strong anti-cancer immunity by promoting T-lymphocyte and natural killer cell proliferation while inhibiting tumor-mediated immune suppression [2][9] - The therapy has shown promising results in the Phase 2 OVATION 2 study, demonstrating a median overall survival increase of 13 months and a median progression-free survival increase of 3 months compared to standard care [6][8] Clinical Trial Information - The OVATION 3 trial is designed with at least 95% statistical power for the primary endpoint of overall survival, with plans for two interim analyses to potentially expedite FDA submission [7] - Currently, four clinical sites are active for patient enrollment, with up to 46 additional sites being considered [3][7] ESMO Conference Presentation - The abstract for the OVATION 3 trial will be presented by Dr. Premal H. Thaker at the ESMO Congress 2025, highlighting the safety and efficacy of IMNN-001 in combination with standard chemotherapy [3][4]

Core Insights - The OVATION 2 Study results reinforce the efficacy of IMNN-001, a DNA-mediated immunotherapy for advanced ovarian cancer, demonstrating significant anti-cancer immune cytokine production post-treatment [1][3] - The ongoing Phase 3 trial, OVATION 3, aims to expand patient recruitment with four sites activated and plans for further site expansion [1][4] Study Details - The Phase 2 OVATION 2 Study involved 112 participants receiving IMNN-001 (100 mg/m administered intraperitoneally weekly) alongside standard neoadjuvant and adjuvant chemotherapy [2][8] - Translational data showed a positive shift in the tumor microenvironment (TME), with increased immune stimulatory T cell ratios and decreased immunosuppressive cells in the majority of participants post-treatment [6][8] Efficacy and Safety - IMNN-001 treatment resulted in a median overall survival (OS) increase of 13 months (HR 0.70) and a median progression-free survival (PFS) increase of 3 months (HR 0.79) compared to standard care [5][11] - The treatment demonstrated a favorable safety profile, with limited to no systemic toxicities reported [3][6] Future Directions - The OVATION 3 Study is currently enrolling patients at four sites, with up to 46 additional sites being considered for activation to accelerate enrollment [7][4] - The positive results from the OVATION 2 Study have led to invitations for presentations at major oncology conferences and publications in peer-reviewed journals [7]