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424B3 - Imunon, Inc. (0000749647) (Filer)
Dr. Faller joins IMUNON with more than 30 years of industry, academic and laboratory experience, with specialized expertise in oncology and immunology LAWRENCEVILLE, N.J., Feb. 10, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the appointment of Douglas V. Faller, M.D., Ph.D., as chief medical officer, effective February 18, 2025. In this role, Dr. Faller will lead the company's clinical strategy including advancing its lead program IMNN-001 for the treatment of newly diagnosed advanced ovarian cancer, which is on track to enter a Phase 3 pivotal trial in the first quarter of 202
Assumes leadership role as Company anticipates multiple near-term clinical milestones Brings extensive leadership and experience in drug development and business strategy LAWRENCEVILLE, N.J., May 08, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, today announced the appointment of Stacy R. Lindborg, Ph.D. as President and Chief Executive Officer, effective May 13, 2024. Dr. Lindborg has served on IMUNON's board of directors since 2021. Dr. Lindborg assumes the leadership of IMUNON at a pivotal time. Topline results from the Phase 2 OVATION 2 Stud
Accomplished pharmaceutical and biotechnology executive to lead IMUNON's clinical programs in ovarian cancer and infectious diseases LAWRENCEVILLE, N.J., Dec. 11, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces the appointment of Sebastien Hazard, M.D. as Chief Medical Officer, effective December 11, 2023. Dr. Hazard brings to IMUNON a strong background in building and leading clinical development organizations, most recently at Bicycle Therapeutics. He will report to IMUNON's President and Chief Executive Officer, Dr. Corinne Le
Renowned Daner-Farber Cancer Institute researcher will advise on the development of IMUNON's FixPlas™ and Indiplas™ modalities in immuno-oncology. LAWRENCEVILLE, N.J., Oct. 06, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces the appointment of Patrick Ott, M.D., Ph.D. to the Company's scientific advisory board. Dr. Ott is the Clinical Director of the Melanoma Disease Center and the Director, Clinical Sciences, of the Center for Immuno-Oncology at the Dana-Farber Cancer Institute. He joins current scientific advisory board members Dan H. Bar
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Highly promising survival data from OVATION 2 Study of treatment of newly diagnosed advanced ovarian cancer to be presented Initiation of Phase 3 trial sites underway for pivotal study of IMNN-001 following alignment on protocol with FDA LAWRENCEVILLE, N.J., April 21, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, 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)
First and only immunotherapy to show meaningful overall survival benefit in a Phase 2 trial in patients with advanced ovarian cancer Initiation of trial sites underway for ground-breaking Phase 3 pivotal trial of DNA-mediated IL-12 therapeutic Company to hold conference call on Tuesday, March 25, 2025, at 2:00 p.m. ET LAWRENCEVILLE, N.J., March 24, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today 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
IMNN-001 remains the first immunotherapy to achieve a meaningful overall survival benefit in advanced ovarian cancer Patient enrollment in Phase 3 pivotal trial of IMNN-001 scheduled to begin in Q1 2025 Company to hold conference call today at 11:00 a.m. ET LAWRENCEVILLE, N.J., Feb. 27, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today reported financial results for the year ended December 31, 2024 and highlighted recent business updates including progress in advancing the IMNN-001 development program toward initiation of a Phase 3 clinical trial in advanced ovarian cancer. "2024 was a piv
Results of IMNN-101 Proof-of-Concept study demonstrate persistent immunogenicity in trial participants and further validate PlaCCine® technology IMNN-101 induced 2- to 4-fold increase in neutralizing antibody (NAb) titers from baseline through Week 4 IMNN-101 continues to show an acceptable safety profile LAWRENCEVILLE, N.J., Feb. 26, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapy and evaluating an adaptation of the platform's potential as a next-generation vaccine, today announced new safety and immunogenicity data from ongoing analyses of results from the Company's first Phase 1 proof-of-concept
LAWRENCEVILLE, N.J., Feb. 20, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, announces that the Company will report full year 2024 financial results before the opening of the U.S. financial markets on Thursday, February 27, 2025. The Company will host a conference call that same day beginning at 11:00 a.m. ET to discuss the results and provide a general business update. To participate in the call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON 2024 Earnings Call. A live webcast of the call will also be available here. The call will
Data reinforce dose-dependent mechanism with IMNN-001 100mg/m2 dose associated with 20% increase in IL-12 levels compared to 79mg/m2 dose Results from OVATION 2 Study continue to validate TheraPlas® technology, demonstrating DNA-mediated production of key anti-cancer immune cytokines following treatment IMNN-001 continues to show favorable safety profile, with no reports of serious immune-related adverse events LAWRENCEVILLE, N.J., Feb. 19, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company entering a pivotal Phase 3 trial of its DNA-mediated immunotherapy, today announced new translational data from ongoing analyses of results from the Company's Phase 2 OVATI
Dr. Faller joins IMUNON with more than 30 years of industry, academic and laboratory experience, with specialized expertise in oncology and immunology LAWRENCEVILLE, N.J., Feb. 10, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the appointment of Douglas V. Faller, M.D., Ph.D., as chief medical officer, effective February 18, 2025. In this role, Dr. Faller will lead the company's clinical strategy including advancing its lead program IMNN-001 for the treatment of newly diagnosed advanced ovarian cancer, which is on track to enter a Phase 3 pivotal trial in the first quarter of 202
Company aligned with FDA on CMC strategy and requirements in preparation of Phase 3 pivotal trial of IMNN-001 Vertical integration of major components assures a high-quality, commercially viable future manufacturing capability On track to initiate Phase 3 pivotal trial of IMNN-001 in first quarter of 2025 LAWRENCEVILLE, N.J., Dec. 19, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the positive outcome of a Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA) regarding production of IMNN-001 for the treatment of women with n
Based on more than six months of additional monitoring, data show continued improvement in overall survival (OS) in intent-to-treat (ITT) population of women newly diagnosed with advanced ovarian cancer Median OS increased from 11 to 13 months in IMNN-001 treatment group based on latest data analysis No change in IMNN-001 favorable safety profile including no reports of serious immune-related adverse events IMUNON remains on track to initiate Phase 3 pivotal trial of IMNN-001 in Q1 2025 LAWRENCEVILLE, N.J., Dec. 10, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced additional clin
FDA Project Team supports the company's proposed Phase 3 trial strategy, including overall trial design, target patient population, treatment schedule, and primary endpoint Final Protocol submission on track for December, supporting initiation of Phase 3 registrational trial in Q1 2025 LAWRENCEVILLE, N.J., Nov. 25, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the outcome of its recent End-of-Phase 2 in-person meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of its investigational interleukin-12 (IL-12) immunotherapy IMNN-001 for the treatment
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First and only immunotherapy to show meaningful overall survival benefit in a Phase 2 trial in patients with advanced ovarian cancer Initiation of trial sites underway for ground-breaking Phase 3 pivotal trial of DNA-mediated IL-12 therapeutic Company to hold conference call on Tuesday, March 25, 2025, at 2:00 p.m. ET LAWRENCEVILLE, N.J., March 24, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today 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
IMNN-001 remains the first immunotherapy to achieve a meaningful overall survival benefit in advanced ovarian cancer Patient enrollment in Phase 3 pivotal trial of IMNN-001 scheduled to begin in Q1 2025 Company to hold conference call today at 11:00 a.m. ET LAWRENCEVILLE, N.J., Feb. 27, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today reported financial results for the year ended December 31, 2024 and highlighted recent business updates including progress in advancing the IMNN-001 development program toward initiation of a Phase 3 clinical trial in advanced ovarian cancer. "2024 was a piv
LAWRENCEVILLE, N.J., Feb. 20, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, announces that the Company will report full year 2024 financial results before the opening of the U.S. financial markets on Thursday, February 27, 2025. The Company will host a conference call that same day beginning at 11:00 a.m. ET to discuss the results and provide a general business update. To participate in the call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON 2024 Earnings Call. A live webcast of the call will also be available here. The call will
LAWRENCEVILLE, N.J., Oct. 31, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immunotherapy and next-generation vaccines, announces that the Company will host a conference call at 11:00 a.m. ET on Thursday, November 7, 2024 to discuss financial results for the third quarter ended September 30, 2024 and provide an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy for the treatment of first-line, locally advanced-stage ovarian cancer, and on its PlaCCine modality, a proprietary DNA plasmid and a synthetic DNA delivery technology for the expression of pat
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 next-generation 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 clinical development for the treatment of first-line, locally advanced-stage ovarian cancer, and on its PlaCCine modality, a proprietary DNA plasmid and a synthetic DNA delivery technolo
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-to-treat patient population compared with the standard-of-care control armOS 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 yet reached at the time of data lockRobust and durable benefit of IMNN-001 observed in OS supported by a three-month improvement in the primary endpoint of progression-free survival (PFS)IMU
Results to be announced at 8:00 a.m. Eastern time, conference call to begin at 8:30 a.m. Eastern time LAWRENCEVILLE, N.J., July 29, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, will issue a news release announcing topline results from the Phase 2 OVATION 2 Study with IMNN-001 in patients with advanced ovarian cancer tomorrow, July 30, at approximately 8:00 a.m. Eastern time, and will host an investment community conference call to discuss the results and answer questions at 8:30 a.m. Eastern time. IMNN-001 is the Company's interleukin-12 (IL-12) immunotherapy based on its TheraPlas™ technology.
Conference Call Begins Today at 11:00 a.m. Eastern Time LAWRENCEVILLE, N.J., May 13, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immuno-oncology therapies and next-generation vaccines, today reported financial results for the three months ended March 31, 2024. The Company also provided an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for first-line treatment of locally advanced ovarian cancer, and on its PlaCCine modality, a proprietary mono- or multi-cistronic DNA plasmid and a synthetic DNA delivery techno
LAWRENCEVILLE, N.J., May 06, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immunotherapy and next-generation vaccines, announces that the Company will host a conference call at 11:00 a.m. ET on Monday, May 13, 2024 to discuss financial results for the first quarter ended March 31, 2024 and provide an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of first-line, locally advanced-stage ovarian cancer, and on its PlaCCine modality, a proprietary mono- or multi-cistronic DNA plasmid and a synthetic DNA
Conference Call Begins Today at 10:00 a.m. Eastern Time LAWRENCEVILLE, N.J., March 28, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immuno-oncology therapies and next-generation vaccines, today reported financial results for the year ended December 31, 2023. The Company also provided an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of first-line, locally advanced-stage ovarian cancer, and on its PlaCCine modality, a proprietary mono- or multi-cistronic DNA plasmid and a synthetic DNA deliver