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]

Core Insights - IMUNON, Inc. is advancing its pivotal Phase 3 trial, OVATION 3, for its investigational therapy IMNN-001, targeting newly diagnosed advanced ovarian cancer [1][4] - New translational data from the Phase 2 OVATION 2 Study will be presented at the AACR Special Conference, highlighting the potential of IMNN-001 [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 [5] - The company is developing its non-viral DNA technology, with its first modality, TheraPlas, aimed at gene-based delivery of cytokines for solid tumors [5] Product Details - IMNN-001 is based on IMUNON's proprietary TheraPlas technology, utilizing an IL-12 DNA plasmid vector in a nanoparticle delivery system to enhance anti-cancer immunity [2] - 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][6] Clinical Trial Insights - The OVATION 3 study is currently enrolling patients at four sites, with plans for up to 46 additional sites [4] - Preliminary results from the OVATION 2 Study indicated a median 13-month increase in OS and a median 3-month increase in PFS for patients treated with IMNN-001 compared to standard care [6] - The use of PARP inhibitors in maintenance therapy further improved outcomes, with patients in the IMNN-001 treatment arm surpassing 5 years since randomization [6]

Core Points - IMUNON, Inc. is a clinical-stage biotechnology company focused on DNA-mediated immunotherapy, currently in Phase 3 development [1][3] - The company will present a pre-recorded session at the H.C. Wainwright 27th Annual Global Investment Conference, with availability starting September 5, 2025 [2] - IMUNON's lead clinical program, IMNN-001, targets advanced ovarian cancer and has completed multiple clinical trials, including a Phase 2 trial [4] Company Overview - IMUNON is developing innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases, differentiating from conventional therapies [3] - The company employs non-viral DNA technology, with two main modalities: TheraPlas for gene-based delivery of therapeutic proteins and PlaCCine for gene delivery of viral antigens [3] Clinical Programs - IMNN-001 is a DNA-based immunotherapy designed for localized treatment of advanced ovarian cancer, instructing the body to produce cancer-fighting molecules at the tumor site [4] - The company has also completed dosing in a first-in-human study for its COVID-19 booster vaccine, IMNN-101 [4] - IMUNON aims to advance its technological capabilities in plasmid DNA to address challenging medical conditions [4]

Core Insights - IMUNON, Inc. has regained compliance with Nasdaq's minimum bid price requirement, ensuring uninterrupted trading on The Nasdaq Capital Market [1][2] - The company recently issued a 15% stock dividend to shareholders, reflecting confidence in its clinical pipeline and commitment to investors [2] - IMUNON's lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, with positive results from the Phase 2 OVATION 2 trial [2][4] 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 [3] - The company is developing non-viral DNA technology, with its first modality, TheraPlas, aimed at gene-based delivery of therapeutic proteins for solid tumors [3] - The second modality, PlaCCine, is designed for gene delivery of viral antigens to elicit strong immunological responses [3] Clinical Development - IMNN-001 instructs the body to produce cancer-fighting molecules at the tumor site and has completed multiple clinical trials, including the Phase 2 OVATION 2 trial [4] - IMUNON has also completed dosing in a first-in-human study of its COVID-19 booster vaccine, IMNN-101 [4] - The company aims to advance its technological capabilities in plasmid DNA to better address difficult-to-treat conditions [4]

Core Insights - IMUNON, Inc. reported financial results for Q2 2025 and highlighted advancements in its Phase 3 clinical trial for IMNN-001, a DNA-mediated immunotherapy for advanced ovarian cancer, along with a 15% stock dividend for shareholders [1][2] Clinical Development - The pivotal Phase 3 OVATION 3 trial for IMNN-001 has commenced, with the first patient treated on July 25, 2025, following robust Phase 2 data showing significant overall survival benefits [2] - The trial design includes two interim analyses and is powered at 95% to detect meaningful overall survival improvements in the intent-to-treat population, with a 99% power in the HRD-positive subgroup [2] - A flexible enrollment strategy will start with a 250-patient HRD-positive subgroup, potentially expanding to a 500-patient all-comers trial, reducing costs by approximately 40% [2] Financial Position - IMUNON has strengthened its balance sheet with over $3 million raised through warrant exercises and ATM sales, while introducing a one-time 15% stock dividend to enhance shareholder value [2] - The company is actively pursuing non-dilutive partnerships to fund the OVATION 3 trial and has achieved compliance with Nasdaq's Shareholder Equity Rule [2] Manufacturing and Operations - IMUNON maintains a reliable in-house manufacturing process for key components of IMNN-001, achieving significant cost reductions compared to outsourcing [2] - Targeted cash conservation measures have been implemented to align resources with the regulatory approval and commercial launch of IMNN-001 [2] Medical Community Engagement - Data from the OVATION 2 study has generated significant interest, leading to unsolicited inquiries from global principal investigators to join the Phase 3 study, indicating strong validation of IMNN-001's potential [2] Background on IMNN-001 - IMNN-001 is designed using IMUNON's TheraPlas® platform and aims to induce potent anticancer immunity through the local secretion of IL-12 [5][8] - The drug has shown positive safety and efficacy results in previous clinical trials, including the recently completed Phase 2 OVATION 2 study [5][8] Market Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases annually in the U.S., and a high risk of recurrence, highlighting the need for effective therapies [6]