Welcome to our dedicated page for Imunon news (Ticker: IMNN), a resource for investors and traders seeking the latest updates and insights on Imunon stock.
Immunon Inc (IMNN) is a clinical-stage biotechnology pioneer developing DNA-based immunotherapies through its proprietary non-viral platform. This page serves as the definitive source for verified company updates, including clinical trial progress, regulatory milestones, and research breakthroughs.
Investors and researchers will find timely updates on key programs like the IMNN-001 ovarian cancer therapy (Phase II completed) and IMNN-101 COVID-19 booster candidate. Our curated news feed covers essential developments including partnership announcements, intellectual property updates, and peer-reviewed study publications.
Content is organized to highlight material events across three core areas: Clinical Trial Advancements, Regulatory Pathway Updates, and Technology Platform Innovations. Each update is vetted for relevance to stakeholders monitoring the company's progress in immuno-oncology and infectious disease applications.
Bookmark this page for structured access to Immunon's official communications, including SEC filings analysis and conference presentation summaries. Check regularly for developments in DNA-based therapeutic approaches that aim to redefine cancer treatment and vaccine development paradigms.
IMUNON (NASDAQ: IMNN) has appointed Douglas V. Faller, M.D., Ph.D., as Chief Medical Officer, effective February 18, 2025. Dr. Faller brings over 30 years of industry, academic, and laboratory experience, specializing in oncology and immunology. He will lead the company's clinical strategy, including advancing IMNN-001 for newly diagnosed advanced ovarian cancer into a Phase 3 pivotal trial in Q1 2025.
Dr. Faller previously served as Chief Medical Officer at Skyhawk Therapeutics and Oryzon Genomics, and held executive positions at Takeda. The Phase 2 OVATION 2 Study has shown promising results, demonstrating clinically meaningful improvements in overall survival and progression-free survival in women treated with IL-12 immunotherapy plus chemotherapy.
As part of his appointment, Dr. Faller will receive inducement stock options to purchase 100,000 shares of common stock, vesting over four years.
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.
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