IMNN-101
- Generic Name
- IMNN-101
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.
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.
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.
Drug Development Updates
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