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IMUNON Reports Updated Phase 2 Data Showing Continued Improvement in Median Overall Survival with IMNN-001 in Women with Newly Diagnosed Advanced Ovarian Cancer
Globenewswire· 2026-03-25 12:05
Core Insights - IMUNON, Inc. reported a significant increase in median overall survival (OS) for women treated with IMNN-001 in the OVATION 2 trial, rising from 11.1 months to 14.7 months after final data analysis [1][2] - The combination of IMNN-001 with standard of care chemotherapy and PARP inhibitors resulted in a median OS increase of 24.2 months [2] - Enrollment in the Phase 3 pivotal trial for IMNN-001 is progressing ahead of schedule, reflecting strong interest from the medical community [1] Clinical Trial Results - The OVATION 2 trial involved 112 patients with newly diagnosed advanced ovarian cancer, evaluating IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy [1][4] - The updated data shows a median OS of 45.1 months for the IMNN-001 treatment arm compared to 30.4 months for standard of care, indicating a continuous improvement in OS [2] - The trial demonstrated that IMNN-001 maintains a favorable safety and tolerability profile, reinforcing its potential as a significant advancement in ovarian cancer treatment [3] Future Developments - The Phase 3 OVATION 3 trial is designed to assess OS as the primary endpoint, with plans for two interim analyses to potentially expedite the submission of a Biologics License Application (BLA) to the FDA [3] - IMUNON aims to enroll approximately 80 patients within the next year, targeting a total of 500 participants across multiple clinical sites [3] Technology and Mechanism - IMNN-001 utilizes IMUNON's proprietary TheraPlas platform, which is a non-viral DNA delivery system designed to enhance the immune response against cancer by promoting local secretion of interleukin-12 (IL-12) [6][9] - IL-12 is known for its role in inducing strong anticancer immunity through T-lymphocyte and natural killer cell proliferation [6] Market Context - Epithelial ovarian cancer remains a significant health challenge, with approximately 20,000 new cases annually in the U.S., and a high recurrence rate post-treatment [7] - The need for innovative therapies is critical, as current standard treatments have not seen meaningful advancements in the last 30 years [3]
IMUNON Public Webcast Highlights Resilience and Innovation in Pursuit of the First Approved Immunotherapy for Ovarian Cancer
Globenewswire· 2025-11-10 18:30
Core Insights - IMUNON, Inc. is in Phase 3 development of its DNA-mediated immunotherapy, IMNN-001, targeting advanced ovarian cancer, showcasing significant potential as highlighted in a recent public webcast featuring key opinion leaders and clinical data [1][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, differentiating itself from conventional therapies [3] - The company is advancing its non-viral DNA technology through two main modalities: TheraPlas for gene-based delivery of cytokines in solid tumors, and PlaCCine for gene delivery of viral antigens [3] Clinical Programs - The lead clinical program, IMNN-001, is a DNA-based immunotherapy for localized treatment of advanced ovarian cancer, having completed multiple trials including a Phase 2 trial (OVATION 2) and currently conducting a Phase 3 trial (OVATION 3) [4] - IMNN-001 functions by instructing the body to produce cancer-fighting molecules at the tumor site, including interleukin-12 and interferon gamma [4] - The company has also completed dosing in a first-in-human study of its COVID-19 booster vaccine, IMNN-101, and aims to advance its technological capabilities through partnerships [4]
IMUNON to Hold Third Quarter 2025 Financial Results and Business Update Conference Call on Thursday, November 13, 2025
Globenewswire· 2025-11-06 13:05
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]
IMUNON to Participate in the H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-09-02 12:05
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]
IMUNON Announces Stock Dividend Boosting Shareholder Value
Globenewswire· 2025-07-28 12:05
Core Viewpoint - IMUNON, Inc. announced a 15% stock dividend, reflecting the company's confidence in its Phase 3 clinical study and long-term growth potential, while also demonstrating dedication to its shareholders [1][3]. Group 1: Stock Dividend Details - The stock dividend program will distribute approximately 448,000 additional shares of IMUNON common stock for each share held, payable to holders of record as of August 7, 2025, with distribution expected on August 21, 2025 [2]. - Stockholders will not need to take any action to receive the dividend, as additional shares will be credited to their accounts [2]. Group 2: Company Strategy and Clinical Programs - The stock dividend is a way for the company to share its recent clinical progress and optimism with shareholders, emphasizing its commitment to creating value while advancing its innovative pipeline of therapies [3]. - IMUNON is focused on developing transformative treatments, including its lead program IMNN-001 for advanced ovarian cancer, which has shown promising Phase 2 clinical data and is currently in a Phase 3 pivotal trial [3][5]. Group 3: Company Overview - IMUNON is a clinical-stage biotechnology company that develops innovative treatments utilizing non-viral DNA technology, with a focus on solid tumors and immunological responses [4]. - The lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, instructing the body to produce cancer-fighting molecules at the tumor site [5].
IMUNON Announces Reverse Stock Split
Globenewswire· 2025-07-23 12:00
Core Viewpoint - IMUNON, Inc. is implementing a reverse stock split at a ratio of 1-for-15 to meet Nasdaq's minimum bid price requirement for continued listing, effective July 25, 2025 [1][2]. Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using non-viral DNA technology for various human diseases [5]. - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, which has completed multiple clinical trials [6]. Reverse Stock Split Details - The reverse stock split will reduce the number of outstanding shares from approximately 31.8 million to about 2.1 million shares, with no fractional shares issued [3]. - Stockholders will not need to take action for the exchange of their shares if held in brokerage accounts [4].
IMUNON Granted Continued Listing Extension by Nasdaq to Complete Compliance Plan
Globenewswire· 2025-07-15 12:05
Core Points - IMUNON, Inc. has received approval from the Nasdaq Hearing Panel for an exception to complete its compliance plan, allowing the company to maintain its Nasdaq listing [1][2] - The Nasdaq Hearing Panel noted that IMUNON has achieved compliance with the Equity Rule through recent fundraising activities and will implement a compliance plan to meet minimum shareholder equity and bid price requirements [2][3] - The Panel approved a tailored exception for IMUNON to regain compliance within a designated timeframe, rather than the full 180 days initially requested [3] 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 lead clinical program, IMNN-001, being a DNA-based immunotherapy for advanced ovarian cancer [6] - IMNN-001 has completed multiple clinical trials, including a Phase 2 trial, and the company has also conducted a first-in-human study for its COVID-19 booster vaccine, IMNN-101 [6]
IMUNON Submits Plan in Consultation with the Exchange to Ensure Compliance with Nasdaq’s Listing Requirement, Anticipates Additional Compliance Period
Globenewswire· 2025-06-30 12:00
Core Viewpoint - IMUNON, Inc. is actively working to regain compliance with Nasdaq's listing requirements, focusing on its lead clinical program, IMNN-001, a DNA-based immunotherapy for advanced ovarian cancer [1][2]. Group 1: Compliance and Financial Status - The company has submitted a plan to Nasdaq to regain compliance with minimum bid price and stockholders' equity requirements [1]. - As of May 31, 2025, the company's stockholders' equity exceeds $3.0 million, surpassing Nasdaq's listing threshold [2]. Group 2: Clinical Development - IMUNON is in Phase 3 development of its lead clinical program, IMNN-001, which targets advanced ovarian cancer [2][4]. - The company has initiated its Phase 3 trial (OVATION 3) in the U.S. and Canada following positive results from the Phase 2 trial (OVATION 2) [2]. - IMNN-001 aims to instruct the body to produce cancer-fighting molecules at the tumor site [4]. Group 3: Technology Platforms - IMUNON is developing two main technology platforms: TheraPlas for gene-based delivery of cytokines and PlaCCine for gene delivery of viral antigens [3]. - The company is also advancing a COVID-19 booster vaccine (IMNN-101) through clinical trials [4].
IMUNON to Present at the Zacks SCR Life Sciences Virtual Investor Forum on June 12th
Globenewswire· 2025-06-05 12:00
Core Points - IMUNON, Inc. is a clinical-stage biotechnology company focused on DNA-mediated immunotherapy, currently in Phase 3 development [1][4] - The company will present at the Zacks SCR Life Sciences Virtual Investor Forum on June 12, 2025, at 11:30 a.m. ET [1] - IMUNON'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 [5] 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 [4] - The company is advancing its non-viral DNA technology through two main modalities: TheraPlas for gene-based delivery of cytokines and PlaCCine for gene delivery of viral antigens [4] Clinical Programs - IMNN-001 instructs the body to produce cancer-fighting molecules at the tumor site, specifically interleukin-12 and interferon gamma [5] - The company has also completed dosing in a first-in-human study of its COVID-19 booster vaccine, IMNN-101 [5] - IMUNON aims to leverage its technologies to address difficult-to-treat conditions, either directly or through partnerships [5]
IMUNON Closes Up To $9.75 Million Private Placement Priced At-The-Market Under Nasdaq Rules
Globenewswire· 2025-05-28 21:16
Core Viewpoint - IMUNON, Inc. has successfully closed a private placement, raising approximately $3.25 million, with potential additional proceeds of up to $6.5 million from short-term warrants [1][3]. Group 1: Financial Details - The company sold 7,222,223 shares of common stock at a price of $0.45 per share, along with short-term warrants to purchase up to 14,444,446 additional shares [1]. - The total gross proceeds from the private placement are approximately $3.25 million before deducting fees and expenses [3]. - If fully exercised, the short-term warrants could provide an additional $6.5 million in gross proceeds [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for working capital and general corporate purposes [3]. Group 3: Regulatory and Offering Details - The securities were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933 and Regulation D, and have not been registered under the Act [4]. - The offering was made only to accredited investors, and the company has agreed to file registration statements with the SEC for resale of the shares [4]. Group 4: Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using non-viral DNA technology [6]. - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, which has completed multiple clinical trials [7]. - IMUNON is also advancing a COVID-19 booster vaccine (IMNN-101) and aims to leverage its technologies to address difficult-to-treat conditions [7].