Company: IMNN
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022120
Chunk: 28

Company: Imunon, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 8
Chunk 28
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 biomarker and genomic analysis.

Patients
are being randomized 1:1 in a two-arm trial. In October 2023, the first patient began treatment at University of Texas MD Anderson Cancer
Center in the Phase I/II Clinical Trial Evaluating IMNN-001 in Combination with Bevacizumab in Advanced Ovarian Cancer. The trial’s
primary endpoint is detection of minimal residual disease (MRD) by second look laparoscopy (SLL), and the secondary endpoint is PFS.
SLL data are expected within one year following the completion of enrollment and final PFS data are expected approximately three years
following the completion of enrollment. This trial will also include a wealth of translational endpoints aimed at understanding the clonal
evolution and immunogenomic features of the MRD phase of ovarian cancer that is currently undetectable by imaging or tumor markers.

A review of the MRD study accomplishments as of September 19, 2025 was conducted and it was determined that study
goals contributing to the IMNN-001 development plan and Break Through Cancer study objectives can be accomplished in a trial of
30 patients. A decision was made to complete enrollment of the trial once the ITT population has reached 30 patients.

As
of September 30, 2025, the ITT population was at seventeen patients in the study at the University of
Texas MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center. John Hopkins Medicine Sidney Kimmel Cancer Care Center
and Stephenson Cancer Center at University of Oklahoma are open to recruitment.

As of November 3, 2025, the ITT population was at twenty patients.

PLACCINE
DNA VACCINE MODALITY: IMNN-101

In
January 2021, the Company announced the filing of a provisional U.S. patent application for a novel DNA-based, investigational vaccine
for preventing or treating infections from a broad range of infectious agents including the coronavirus disease using its PLACCINE DNA
vaccine modality (“PLACCINE”). The provisional patent covers a family of novel composition of multi-cistronic vectors and
polymeric nanoparticles that comprise the PLACCINE DNA vaccine platform technology for preventing or treating infectious agents that
have the potential for global pandemics, including the SARS-CoV-2 virus and its variations, using the Company’s TheraPlas platform
technology.

Imunon’s
PLACCINE DNA vaccine modality is characterized by a single mono-cistronic or multi-c