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Imunon, Inc. (symbol: IMNN) is a biopharmaceutical company focused on the research and development of targeted therapies to address unmet medical needs in oncology. With the recent acquisition of EGEN, Inc., Imunon has transformed into a fully integrated company boasting a comprehensive, multi-phase clinical pipeline. The company specializes in nucleic acid-based immunotherapies and other anti-cancer DNA/RNA therapies. Their platform technologies are designed to leverage the body's natural mechanisms, aiming to generate safe, effective, and durable responses across a wide range of human diseases.
Imunon is committed to innovation and excellence in the field of biotechnology, seamlessly integrating research from the laboratory to clinical applications. By harnessing the building blocks of life, the company strives to work in harmony with the body's immune system to develop groundbreaking treatments.
The company's current projects include a variety of clinical trials that seek to validate the efficacy and safety of their therapies. These efforts are supported by a team of experts with extensive experience in drug development. Imunon's financial health is robust, enabling continuous research and the potential for future growth. Additionally, the company values strategic partnerships that bolster its capabilities and extend its reach in the biotech industry.
For investors and stakeholders, Imunon, Inc. represents a promising opportunity in the field of biopharmaceuticals, with a strong focus on innovative cancer treatments and a commitment to addressing significant healthcare challenges.
IMUNON (NASDAQ: IMNN) announced a successful Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the FDA regarding IMNN-001, their DNA-mediated immunotherapy for advanced ovarian cancer. The FDA aligned with IMUNON's manufacturing strategy and requirements for their upcoming 500-patient Phase 3 pivotal trial, scheduled to begin in Q1 2025.
Key outcomes include FDA's acceptance of the company's potency assay measuring interferon-gamma (IFN-γ) for both Phase 3 and commercial use, and agreement on the strategy to establish comparability between IMUNON's in-house manufacturing and previous CDMO-produced components. The company's Huntsville, Alabama facility will handle the manufacturing process, ensuring cost-efficient production for both clinical trials and potential commercialization.
IMUNON (NASDAQ: IMNN) reported improved overall survival (OS) data from its Phase 2 OVATION 2 Study of IMNN-001 for advanced ovarian cancer treatment. After seven additional months of monitoring, the hazard ratio improved from 0.74 to 0.69, with median OS increasing from 11.1 to 13 months in the IMNN-001 plus standard-of-care (SoC) treatment group compared to SoC alone.
The study, involving 112 newly diagnosed advanced ovarian cancer patients, showed that over one-third of participants survived beyond 36 months, with 62% from the IMNN-001 treatment arm. The treatment maintained its favorable safety profile with no serious immune-related adverse events. IMUNON plans to initiate a Phase 3 pivotal trial in Q1 2025.
IMUNON (NASDAQ: IMNN) announced successful results from its End-of-Phase 2 meeting with the FDA for IMNN-001, its DNA-mediated immunotherapy for advanced ovarian cancer. The FDA supported the company's proposed Phase 3 trial strategy, including trial design, patient population, and endpoints. The 500-patient Phase 3 trial is scheduled to begin in Q1 2025. The company's Phase 2 OVATION 2 Study showed approximately one-year (35%) improvement in overall survival when IMNN-001 was combined with standard chemotherapy compared to chemotherapy alone. The treatment demonstrated good tolerability with no serious immune-related adverse events.
IMUNON announced positive Phase 2 OVATION 2 trial results for IMNN-001 in advanced ovarian cancer. The study of 112 patients showed that IMNN-001 plus standard chemotherapy improved overall survival by 35% (40.5 vs 29.4 months) and progression-free survival by 25% (14.9 vs 11.9 months) compared to chemotherapy alone. The treatment demonstrated better surgical outcomes with a 64.6% response rate versus 52.1% for standard care. IMNN-001 was well-tolerated with no serious immune-related adverse events. The company plans to initiate a Phase 3 pivotal trial in Q1 2025 following FDA discussions.
IMUNON reported Q3 2024 financial results and provided updates on its clinical developments. The company highlighted compelling topline results from the OVATION 2 Study with IMNN-001 in advanced ovarian cancer, showing an 11.1-month overall survival improvement compared to standard care. The company plans to begin a 500-patient pivotal Phase 3 study in Q1 2025. Financial results showed $10.3 million in cash and investments as of September 30, 2024, with Q3 net loss of $4.9 million ($0.34 per share). Research and development expenses increased to $3.3 million from $2.0 million in Q3 2023.
IMUNON (NASDAQ: IMNN) has scheduled its Third Quarter 2024 Financial Results conference call for Thursday, November 7, 2024, at 11:00 a.m. ET. The company will discuss Q3 2024 financial performance and provide updates on two key programs: IMNN-001, a DNA-based IL-12 immunotherapy for first-line ovarian cancer treatment, and PlaCCine, their DNA plasmid technology for next-generation vaccine development. The call will be accessible via phone and webcast, with replay available until November 21, 2024.
IMUNON announced the acceptance of late-breaking data presentation from Phase 2 OVATION 2 Study of IMNN-001 at SITC's 39th Annual Meeting. The study showed an 11.1-month increase in median overall survival among patients treated with IMNN-001 compared to standard care, representing a 35% improvement in survival. The company will hold an in-person End-of-Phase 2 meeting with the FDA to discuss the design of a Phase 3 pivotal study, expected to begin in Q1 2025. IMNN-001 is a DNA-mediated immunotherapy using TheraPlas® platform technology, designed to produce and secrete IL-12 protein for strong anti-cancer immunity.
IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company developing DNA-mediated immunotherapy, has announced the approval of inducement stock options by its Compensation Committee. The grants include:
1. Options to purchase 60,000 shares of common stock for one individual hired in Q4 2024.
2. Options to purchase 50,000 shares of common stock for Susan Eylward, hired as General Counsel and Secretary effective October 7, 2024.
These grants, made on October 7, 2024, comply with Nasdaq Listing Rule 5635(c)(4). The options have a 10-year term and a four-year vesting schedule, with 25% vesting on the first anniversary and the remainder vesting annually until fully vested on the fourth anniversary, subject to continued employment.
IMUNON (NASDAQ: IMNN) announced its first Ovarian Cancer R&D Day on September 18, 2024, in New York City. The event will focus on IMNN-001, their investigational DNA-mediated immunotherapy for advanced ovarian cancer. Key presentations will cover:
1. Positive topline data from the Phase 2 OVATION 2 Study, showing an 11.1-month increase in median overall survival.
2. Insights from clinical investigators, immunology experts, and biostatisticians.
3. The role of IL-12 in cancer treatment.
4. Ongoing Phase 1/2 study of IMNN-001 with bevacizumab.
5. Plans for a Phase 3 registration study.
The event aims to highlight IMNN-001's potential to change the treatment paradigm for newly diagnosed ovarian cancer patients.
IMUNON (NASDAQ: IMNN) is hosting an R&D Day on September 18th at the Harvard Club in New York City from 10:00 a.m. to 1:00 p.m. Eastern time. The event follows the announcement of top-line data from their randomized Phase II Ovation 2 Study, which showed an 11.1-month increase in median overall survival for advanced ovarian cancer patients, representing a 35% improvement in survival.
The program will feature ovarian cancer experts, principal investigators from the OVATION 2 Study, and discussions on IMNN-001's potential role in treating advanced ovarian cancer. Management will also discuss next steps for their immunotherapy and prospects for extending patient survival. While in-person attendance is encouraged, a virtual option will be available. Program details and RSVP information will be provided soon.
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