Core Viewpoint - IMUNON, Inc. is set to host a conference call on August 14, 2024, to discuss its Q2 2024 financial results and provide updates on its clinical development programs, particularly focusing on IMNN-001 for ovarian cancer and its PlaCCine modality for next-generation vaccines [1]. Group 1: Company Overview - IMUNON is a clinical-stage biotechnology company that develops DNA-mediated immunotherapy and next-generation vaccines, utilizing non-viral DNA technology [4]. - The company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy currently in Phase 2 development for advanced ovarian cancer, designed to produce cancer-fighting molecules at the tumor site [5]. Group 2: Clinical Development Programs - IMNN-001 targets first-line, locally advanced-stage ovarian cancer and aims to instruct the body to generate durable levels of IL-12 and interferon gamma at the tumor site [5]. - The PlaCCine modality is a proprietary DNA plasmid technology aimed at delivering viral antigens to elicit strong immunological responses for vaccine development [1][4]. Group 3: Conference Call Details - The conference call will take place at 11:00 a.m. ET on August 14, 2024, with participation options available via toll-free and international dialing [2]. - An archived replay of the call will be accessible until August 28, 2024, with specific access codes provided for listeners [3].

LAWRENCEVILLE, N.J., Aug. 07, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immunotherapy and nextgeneration vaccines, announces that the Company will host a conference call at 11:00 a.m. ET on Wednesday, August 14, 2024 to discuss financial results for the second quarter ended June 30, 2024 and provide an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 ...

Core Insights - IMUNON, Inc. announced positive topline results from the Phase 2 OVATION 2 Study of IMNN-001, demonstrating a significant improvement in overall survival (OS) for patients with advanced ovarian cancer compared to standard-of-care treatment [1][3][8] - The study showed a hazard ratio of 0.74 in the intent-to-treat population, indicating a 35% improvement in survival, with a median OS increase of 11.1 months [7][19] - IMUNON plans to initiate a registrational study in Q1 2025 and is preparing for an End-of-Phase 2 meeting with the U.S. FDA [1][10] Study Design and Results - The OVATION 2 Study was a randomized trial evaluating the safety and efficacy of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy in patients newly diagnosed with advanced epithelial ovarian cancer [2][12] - A total of 112 patients were enrolled and randomized 1:1 to receive either IMNN-001 plus standard-of-care chemotherapy or standard-of-care alone [2] - The primary endpoint of progression-free survival (PFS) showed a three-month improvement for the IMNN-001 treatment arm, with a hazard ratio of 0.79, indicating a 27% improvement in delaying progression [17] Clinical Significance - The results indicate that the addition of IMNN-001 could extend median OS from 29 months with standard treatment to 40 months, which is considered clinically meaningful [3][19] - Among patients receiving three or more doses of IMNN-001, there was a further increase in median OS by 15.7 months, with a hazard ratio of 0.64, representing a 56% improvement in survival [7][9] - For patients treated with a PARP inhibitor, the hazard ratio decreased to 0.41, with median OS not yet reached in the IMNN-001 arm compared to 37.1 months in the control arm [7][19] Future Directions - IMUNON aims to advance IMNN-001 into a Phase 3 pivotal study as soon as possible, with plans to present full study results at an upcoming medical conference [8][10] - The company is focused on addressing the unmet medical needs of over 300,000 women diagnosed with advanced ovarian cancer annually [8][12]

Core Insights - IMUNON, Inc. announced positive topline results from the Phase 2 OVATION 2 Study of IMNN-001, demonstrating significant improvements in overall survival (OS) and progression-free survival (PFS) for patients with advanced ovarian cancer [1][4] Study Results - The Phase 2 OVATION 2 Study showed a hazard ratio of 0.74 for OS in the intent-to-treat (ITT) population, indicating a 35% improvement in survival compared to standard-of-care [2][3] - Patients receiving three or more doses of IMNN-001 experienced a median OS increase of 15.7 months, with a hazard ratio of 0.64, representing a 56% improvement in survival [2] - For nearly 40% of participants treated with a PARP inhibitor, the hazard ratio further decreased to 0.41, with median OS not yet reached in the IMNN-001 arm compared to 37.1 months in the control arm [2] Progression-Free Survival - The primary endpoint of the trial, PFS, showed a three-month improvement compared to standard-of-care, with a hazard ratio of 0.79, indicating a 27% improvement in delaying disease progression [3] Future Plans - IMUNON plans to initiate a registrational study in Q1 2025 and will hold an End-of-Phase 2 meeting with the U.S. FDA to discuss the protocol for a Phase 3 study [1][6] Company Background - IMUNON is a clinical-stage biotechnology company focused on innovative treatments utilizing non-viral DNA technology, with IMNN-001 being a key product in development for advanced ovarian cancer [12][13]

Core Viewpoint - IMUNON, Inc. is set to announce topline results from the Phase 2 OVATION 2 Study of its DNA-mediated immunotherapy, IMNN-001, for advanced ovarian cancer on July 30, 2024, at 8:00 a.m. Eastern time, followed by a conference call at 8:30 a.m. Eastern time to discuss the results [1]. Group 1: 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, differentiating itself from conventional therapies [4]. - The company is advancing its non-viral DNA technology, with its first modality, TheraPlas®, designed for coding cytokines and therapeutic proteins for solid tumors, and a second modality, PlaCCine®, for delivering DNA-coded viral antigens [4]. Group 2: Clinical Programs - The lead clinical program, IMNN-001, is a DNA-based immunotherapy currently in Phase 2 development for localized treatment of advanced ovarian cancer, which instructs the body to produce cancer-fighting molecules at the tumor site [5]. - IMUNON has also initiated a first-in-human study for its COVID-19 booster vaccine, IMNN-101, and aims to leverage its technological advancements to better serve patients with challenging conditions [5].

Core Insights - IMUNON, Inc. is set to announce topline results from the Phase 2 OVATION 2 Study for its DNA-mediated immunotherapy, IMNN-001, targeting advanced ovarian cancer on July 30, 2024, at 8:00 a.m. Eastern time [3] - The company will host a conference call at 8:30 a.m. Eastern time to discuss the results and answer questions from the investment community [3][4] 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 [5] - The company is advancing its non-viral DNA technology, with its first modality, TheraPlas®, designed for coding cytokines and therapeutic proteins for solid tumors [5] - The second modality, PlaCCine®, is aimed at delivering DNA-coded viral antigens to provoke strong immunological responses [5] Clinical Programs - The lead clinical program, IMNN-001, is a DNA-based immunotherapy in Phase 2 development for localized treatment of advanced ovarian cancer, which instructs the body to produce cancer-fighting molecules at the tumor site [6] - IMUNON has also initiated a first-in-human study for its COVID-19 booster vaccine, IMNN-101, indicating the company's commitment to advancing its technological capabilities in plasmid DNA [6]

Core Insights - IMUNON is advancing its Phase 2 OVATION 2 Study to evaluate the safety and efficacy of IMNN-001 in combination with neoadjuvant chemotherapy for patients with advanced ovarian cancer [9][6] - The study aims to inform the design of a future Phase 3 trial, focusing on primary efficacy endpoints such as Progression Free Survival (PFS) and Overall Survival (OS) [13][17] Company Overview - IMUNON is a clinical-stage biotechnology company developing non-viral DNA-mediated immunotherapy, with a focus on innovative treatments that leverage the body's natural immune responses [3][9] - The company's lead program, IMNN-001, is a DNA-based immunotherapy designed to produce interleukin-12 and interferon gamma at the tumor site, targeting advanced ovarian cancer [15][9] Study Details - The OVATION 2 Study involved 110 patients, with treatment designed to shrink tumors before surgical removal, followed by additional chemotherapy [1][9] - Patients were randomized to receive either NACT plus IMNN-001 or standard-of-care NACT, with the IMNN-001 group receiving up to 17 doses of 100 mg/m² [1][9] Clinical Context - Epithelial ovarian cancer is a significant health concern, with approximately 22,000 new cases annually in the U.S., and a high recurrence rate of 75% in advanced stages [7][9] - The five-year survival rates for patients diagnosed with Stage III/IV disease are notably low, at 41% and 20% respectively, highlighting the need for improved therapies [7][9] Future Expectations - IMUNON anticipates reporting topline results, including hazard ratios, by the end of July 2024, following the completion of data analysis by independent statisticians [9][17] - The company aims to leverage the findings from the OVATION 2 Study to enhance the therapeutic potential of its plasmid DNA technology for challenging conditions [15][9]

Core Insights - IMUNON has achieved a significant milestone by reaching data lock for the OVATION 2 Study, which evaluates the safety and efficacy of IMNN-001 in patients with advanced ovarian cancer [2][6] - The study aims to provide insights for the design of a future Phase 3 trial, focusing on primary efficacy endpoints such as Progression Free Survival (PFS) and Overall Survival (OS) [7][8] Group 1: Study Overview - The OVATION 2 Study is assessing the intraperitoneal administration of IMNN-001 in combination with neoadjuvant chemotherapy for patients newly diagnosed with advanced epithelial ovarian cancer [1][6] - A total of 110 patients were fully enrolled in the study by September 2022, with a randomization of 1:1 for treatment comparison [1][6] - The study has reached a median treatment observation duration of 16 months, as required by the protocol [6] Group 2: Treatment Details - IMNN-001 is administered alongside neoadjuvant chemotherapy, with patients receiving up to 17 doses of 100 mg/m² [1][6] - The treatment strategy is designed to shrink tumors for optimal surgical removal, followed by additional cycles of adjuvant chemotherapy [1][6] Group 3: Expected Outcomes - IMUNON anticipates reporting topline results, including hazard ratios, by the end of July 2024 [6] - The primary efficacy analysis will be based on the Intent to Treat (ITT) population, with secondary endpoints including OS, Objective Response Rate, and Chemotherapy Response Score [7] Group 4: Company Background - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using non-viral DNA technology [10][11] - The lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, designed to induce the production of cancer-fighting molecules at the tumor site [11]

Core Insights - IMUNON, Inc. has initiated the Phase 1 clinical trial for its IMNN-101 vaccine, utilizing the proprietary PlaCCine platform aimed at providing a seasonal COVID-19 vaccine [1][2][3] - The trial will evaluate the safety, tolerability, and immune response of IMNN-101 against the SARS-CoV-2 Omicron XBB1.5 variant, with topline data expected by the end of 2024 [2][3] - The company aims to demonstrate that its PlaCCine technology offers superior durability of immune protection compared to existing mRNA vaccines [4][7] Company Overview - IMUNON is a clinical-stage biotechnology company focused on non-viral DNA-mediated immunotherapy, with a portfolio that includes the TheraPlas® and PlaCCine® modalities [4][5] - The lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer currently in Phase 2 development [5] - The company is leveraging its innovative technologies to address challenging medical conditions and enhance patient outcomes [4][5] Clinical Trial Details - The Phase 1 study will enroll 24 participants, testing three escalating doses of IMNN-101, with eight participants per dose [3] - Primary objectives include assessing safety and tolerability, while secondary objectives focus on evaluating neutralizing antibody responses and their durability [3] - Preclinical data suggests that the immune protection from IMNN-101 may exceed that of published mRNA vaccine data, with immunogenicity and stability at workable temperatures enhancing commercial viability [7]

Core Viewpoint - IMUNON, Inc. announces the acceptance of an abstract for a Phase 2 study involving IMNN-001, bevacizumab, and neoadjuvant chemotherapy in advanced epithelial ovarian cancer patients, to be presented at the ASCO annual meeting [1][2]. Group 1: Study Details - The abstract titled "A phase II study evaluating the effect of IMNN-001 on second-look laparoscopy when administered in combination with bevacizumab and neoadjuvant chemotherapy in patients newly diagnosed with advanced epithelial ovarian cancer" will be presented on June 3rd [2]. - The study is actively recruiting patients in the U.S. and is led by Dr. Amir A Jazaeri from The University of Texas MD Anderson Cancer Center [2][3]. Group 2: Funding and Clinical Significance - The study is substantially funded by Break Through Cancer, with MD Anderson as the leading clinical site, highlighting its importance in IMUNON's IL-12 gene therapy development for ovarian cancer [3]. - Dr. Sebastien Hazard, IMUNON's chief medical officer, emphasized the observed synergies in pre-clinical experiments with the combination of IMNN-001 and bevacizumab [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 effective responses to various diseases [4]. - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, currently in Phase 2 development [5]. - IMUNON is also entering a first-in-human study of its COVID-19 booster vaccine, IMNN-101, showcasing its commitment to advancing plasmid DNA technology [5].