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Thursday, March 28, 2024

Imunon results, business update

 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immuno-oncology therapies and next-generation vaccines, today reported financial results for the year ended December 31, 2023. The Company also provided an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of first-line, locally advanced-stage ovarian cancer, and on its PlaCCine modality, a proprietary mono- or multi-cistronic DNA plasmid and a synthetic DNA delivery technology for the expression of pathogen antigens in preclinical studies for the development of next-generation vaccines.

Highlights of 2023 and recent weeks include the following:

  • Reported interim progression-free survival (PFS) and overall survival (OS) data with IMNN-001 in the Phase 2 OVATION 2 Study in patients with advanced ovarian cancer. Interim data from the intent-to-treat (ITT) population showed an approximate 30% delay in disease progression or death in the treatment arm compared with the control arm, and preliminary OS data showed an approximate nine-month improvement in the treatment arm over the control arm.
  • Enrolled four patients in a Phase 1/2 clinical trial evaluating IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer at the University of Texas MD Anderson Cancer Center, and recently added Memorial Sloan Kettering Cancer Center as a clinical site for this study.
  • Announced results from a non-human primate study confirming PlaCCine as a viable modality for the development of the next generation of prophylactic vaccines.
  • Reported pre-clinical data demonstrating PlaCCine vaccines elicit robust and more durable T cell responses than commercial mRNA vaccines in animal models, signaling that PlaCCine vaccines may provide greater protection against reinfection, hospitalization or death.
  • Submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the first quarter of 2024 for a Phase 1/2 proof-of-concept clinical trial with a seasonal COVID-19 booster vaccine.
  • Launched a new current Good Manufacturing Practices production facility to efficiently support R&D with significantly lower costs for infectious disease vaccines, and DNA-based immuno-oncology therapies.

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