Clinical Trials
15
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1982
Active, not recruiting
1
6.7%
Completed
7
46.7%
Recruiting
2
13.3%
Terminated
1
6.7%
Unknown
2
13.3%
Withdrawn
2
13.3%
No approval data available
- IMUNON, Inc. completed a $7 million registered direct offering with a healthcare-focused institutional investor to fund its Phase 3 DNA-mediated immunotherapy development. - The offering includes 1,939,114 shares of common stock and warrants priced at $3.61 per unit, with warrants exercisable at $3.482 per share for five years. - The biotechnology company focuses on innovative treatments that harness the body's natural mechanisms to generate safe, effective and durable responses across human diseases.
- IMUNON's Phase 3 OVATION 3 study evaluating IMNN-001 in combination with standard chemotherapy for newly diagnosed advanced ovarian cancer continues to advance enrollment toward future BLA filing. - Previous Phase 2 OVATION 2 data demonstrated a 13-month extension in median overall survival with IMNN-001, showing a hazard ratio of 0.70 in the intent-to-treat population. - New minimal residual disease (MRD) study data reveals IMNN-001's mechanism of action, showing IL-12 production by macrophages and tumor microenvironment remodeling that transforms "cold" tumors into "hot" ones. - The therapy targets ovarian cancer, a disease affecting 20,000 women annually in the U.S. and 300,000 worldwide, with high recurrence rates and low five-year survival.
- IMUNON's IMNN-101 DNA vaccine demonstrated better durability of protection compared to mRNA vaccines after a single dose targeting SARS-CoV-2 Omicron XBB1.5 in Phase 1 trial results. - The vaccine induced up to a 3-fold median increase in serum neutralizing antibody titers at six months, with stronger responses observed in higher dose cohorts (2.0 mg and 1.0 mg). - The company is actively seeking strategic partnerships to advance its PlaCCine technology platform, which offers enhanced durability, temperature stability, and scalable manufacturing advantages. - IMUNON will present proof-of-concept data at two major vaccine conferences in October and November 2025 to showcase the technology's potential.
- IMUNON received approval from the Nasdaq Hearing Panel for a listing extension after demonstrating compliance with equity requirements through recent fundraising activities. - The company's lead program IMNN-001, a DNA-based immunotherapy for advanced ovarian cancer, has progressed to Phase 3 trials following unprecedented Phase 2 results. - IMUNON's stockholders' equity exceeded $3.0 million as of May 31, 2025, surpassing Nasdaq's listing threshold requirements. - The company is developing two DNA technology platforms: TheraPlas® for cytokine delivery in solid tumors and PlaCCine® for viral antigen delivery.
- Researchers are developing innovative non-viral delivery systems for IL-12 immunotherapy, targeting the tumor microenvironment while minimizing systemic toxicity in ovarian cancer treatment. - IMUNON's TheraPlas platform utilizes DNA plasmid vectors in nanoparticles to deliver IL-12 locally to tumors, potentially offering a breakthrough in treating advanced ovarian cancer. - Despite being a powerful anti-cancer cytokine discovered in 1989, IL-12's therapeutic potential has been limited by systemic side effects, prompting the development of targeted delivery approaches.
- Imunon's novel DNA plasmid vaccine demonstrated a favorable safety profile with no serious adverse events reported in the clinical trial. - The vaccine generated robust immune responses in study participants, marking a significant advancement in DNA-based vaccine technology. - Results support further development of the platform technology for potential applications in multiple therapeutic areas.
- IMNN-101, a novel DNA-based COVID-19 vaccine, demonstrated a 2-4 fold increase in neutralizing antibody titers through Week 4 in Phase 1 trial participants. - The PlaCCine® technology-based vaccine showed cross-reactivity against multiple COVID-19 variants and maintained stability at workable temperatures for up to one year. - The trial involving 24 healthy volunteers confirmed IMNN-101's safety profile with no serious adverse effects, positioning it as a potential alternative to current mRNA vaccines.
- Imunon's IMNN-001, combined with chemotherapy, demonstrated an 11.1-month improvement in overall survival in patients with advanced ovarian cancer in the OVATION-2 trial. - The planned Phase 3 trial aims to replicate these findings and potentially bring a new treatment option to market for ovarian cancer patients. - IMNN-001 utilizes a DNA plasmid vector to deliver IL-12 locally within the tumor microenvironment, stimulating an anti-cancer immune response. - The treatment has shown a manageable safety profile, with increased gastrointestinal adverse effects mitigated by pain management protocols.
- IMUNON's IMNN-001, combined with standard chemotherapy, demonstrated a 35% improvement in overall survival for advanced ovarian cancer patients compared to chemotherapy alone. - The Phase 2 OVATION 2 study also revealed a 25% improvement in progression-free survival with the IMNN-001 treatment, suggesting a potential advancement in managing the disease. - IMNN-001 was generally well-tolerated, with no reports of severe immune-related adverse events, supporting its safety profile in combination with chemotherapy. - IMUNON plans to initiate a Phase 3 pivotal trial of IMNN-001 in Q1 2025, aiming to confirm these promising results and potentially bring a new treatment option to patients.
• IMUNON's IMNN-001 demonstrated an 11.1-month overall survival improvement in advanced ovarian cancer patients compared to standard of care, marking a significant clinical advancement. • The OVATION 2 study highlighted a 35% survival improvement in the intent-to-treat population, with even greater benefits observed in patients also treated with PARP inhibitors. • IMUNON is preparing for an End-of-Phase 2 meeting with the FDA and plans to initiate a 500-patient pivotal Phase 3 study in early 2025. • New clinical data from the OVATION 2 Study of IMNN-001 was presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting.
