September 18th Event in New York City to Include a Review of the Opportunity for Investigational Therapy IMNN-001 (IL-12) to Treat Advanced Ovarian Cancer and Clinical Development Timeline LAWRENCEVILLE, N.J., Sept. 09, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, will hold its first Ovarian Cancer R&D Day on September 18, 2024 at the Harvard Club (35 West 44th Street) in New York City. The event will feature pr ...

R&D Discussion in New York City to Review IL-12's Potential to Treat Ovarian Cancer IMUNON LHA Investor Relations David Gaiero Kim Sutton Golodetz 978-376-6352 212-838-3777 dgaiero@imunon.com kgolodetz@lhai.com Program Features Ovarian Cancer Thought Leaders, OVATION 2 Study Investigators, and Oncology Experts LAWRENCEVILLE, N.J., Aug. 28, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, invites investors to mark th ...

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]

Phase 2 OVATION 2 Study of IMNN-001 administered with standard-of-care chemotherapy as first-line treatment demonstrates a hazard ratio of 0.74 in overall survival (OS) in the intent-totreat patient population compared with the standard-of-care control arm OS was extended by 15.7 months in patients receiving three or more doses of IMNN-001 in the 17- dose protocol Patients also receiving maintenance PARP inhibitor therapy demonstrated an OS hazard ratio of 0.41 in the IMNN-001 trial arm with median OS not y ...

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]

OVATION 2 is evaluating the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant chemotherapy (NACT) in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by thr ...

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]