Imunon
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1982-01-01
- Employees
- 33
- Market Cap
- $16.7M
- Website
- http://imunon.com
Novel IL-12 Delivery System Shows Promise for Advanced Ovarian Cancer Treatment
• 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 DNA Plasmid Vaccine Shows Promising Safety and Immune Response in Clinical Trial
• 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.
IMUNON's DNA Vaccine Shows Promising Immune Response Against COVID-19 in Phase 1 Trial
• 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.
FDA Grants Breakthrough Therapy Status to Radiprodil for GRIN-Related Seizure Treatment
• GRIN Therapeutics' radiprodil receives FDA Breakthrough Therapy designation for treating seizures in patients with GRIN-related neurodevelopmental disorder, showing 86% median reduction in seizure frequency during Phase 1b trials.
• The investigational drug demonstrated significant efficacy in Phase 1b Honeycomb study, with 71% of patients achieving over 50% reduction in countable motor seizures and most patients showing behavioral improvements.
• The company plans to initiate Phase 3 pivotal trials in mid-2025, backed by a $200M capital commitment from Blackstone Life Sciences, to evaluate radiprodil's impact on seizures and behavioral outcomes.
Nanovaccines and mRNA Technology Spearhead New Era in Cancer Immunotherapy
• Nanovaccines leverage nanotechnology to enhance the delivery of cancer antigens to immune cells, potentially overcoming the limitations of traditional cancer vaccines.
• Clinical trials are underway to evaluate the safety and efficacy of nanovaccines, with early results showing promising immune responses and manageable side effects.
• mRNA-4157 (V940), a melanoma vaccine developed by Moderna and Merck, has demonstrated promising trial results and may receive FDA approval in 2025.
• Personalized mRNA vaccines, such as those being developed by BioNTech in collaboration with the NHS, are entering clinical trials targeting various cancers.
Imunon's IMNN-001 Shows Promise in Ovarian Cancer, Phase 3 Trial Planned
• 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 Shows Promise in Advanced Ovarian Cancer Treatment
• 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 Shows Promise in Advanced Ovarian Cancer Treatment
• 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.
Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025
• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.
• EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration.
• Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option.
• Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.
IMUNON's IMNN-001 Receives FDA Agreement on Manufacturing for Phase 3 Ovarian Cancer Trial
• IMUNON has secured FDA alignment on its Chemistry, Manufacturing, and Controls (CMC) strategy for IMNN-001, an immunotherapy targeting advanced ovarian cancer.
• The FDA has accepted IMUNON's potency assay for measuring interferon-gamma (IFN-γ) levels, crucial for both Phase 3 trials and potential commercial use.
• IMUNON's in-house manufacturing facility in Huntsville, Alabama, will produce IMNN-001, ensuring cost-efficient production and quality control.
• The company remains on track to initiate the 500-patient Phase 3 pivotal trial of IMNN-001 in the first quarter of 2025.
IMUNON's IMNN-001 Demonstrates Significant Survival Benefit in Ovarian Cancer Phase 2 Trial
• IMUNON's IMNN-001 Phase 2 OVATION 2 study showed an 11.1-month increase in median overall survival compared to standard care for ovarian cancer patients.
• The study represents a 35% improvement in survival rates with IMNN-001, highlighting its potential in treating advanced ovarian cancer.
• IMUNON will hold an in-person 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 designed to produce IL-12 protein, enhancing anti-cancer immunity through T-lymphocyte and natural killer cell proliferation.
IMUNON's IMNN-001 Shows Promise in Advanced Ovarian Cancer Treatment
• IMUNON will host an Ovarian Cancer R&D Day on September 18, 2024, featuring updates on IMNN-001, an investigational therapy for ovarian cancer.
• Phase 2 OVATION 2 study data showed IMNN-001 treatment was associated with an 11.1-month increase in median overall survival in advanced ovarian cancer patients.
• The R&D Day will include presentations from experts discussing the clinical significance of OVATION 2 results and the potential role of IMNN-001 in treatment.
• IMUNON executives will outline the next steps for IMNN-001's development program, including plans for a Phase 3 registration study.
IMUNON's IMNN-001 Enrolls Patients in Phase 1/2 Trial for Advanced Ovarian Cancer
• IMUNON's IMNN-001, combined with bevacizumab, is being evaluated in a Phase 1/2 clinical trial for advanced ovarian cancer patients undergoing frontline neoadjuvant therapy.
• The trial randomizes patients to receive either standard chemotherapy plus bevacizumab or the same regimen with the addition of IMNN-001, assessing minimal residual disease.
• The primary endpoint is the detection of minimal residual disease via second-look laparoscopy, with progression-free survival as a secondary endpoint.
• Initial data from the trial are expected within one year of enrollment completion, with final progression-free survival data anticipated approximately three years after.
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