Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 50

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 2
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 the Company announced that it had received Fast Track designation from the FDA for IMNN-001 and also provided an update
on the OVATION 2 Study. 

In
September 2022, the Company announced that its Phase I/II OVATION 2 Study with IMNN-001 in advanced ovarian cancer had completed enrollment
with 113 patients. In September 2023, the Company announced interim PFS and OS data with IMNN-001 in its Phase I/II OVATION 2 Study.
Interim clinical data from the ITT population showed efficacy trends in PFS. Preliminary OS data followed a similar trend, showing an approximate 9-month
improvement in the treatment arm over the control arm.

Subgroup
analyses showed patients treated with a PARP inhibitor (“PARPi”) as maintenance therapy had longer PFS and OS if they were
also treated with IMNN-001 compared with patients treated with NACT only. This was not a pre-specified subgroup when the protocol was
initiated as PARP inhibitors were approved after the OVATION 2 Study was initiated. However given the change in the standard of care,
this subgroup was pre-specified in the statistical analysis plan prior to the study read out.

    ●
    The
    median PFS in the PARPi + NACT group and the PARPi + NACT + IMNN-001 group was 15.7 months and 23.7 months, respectively.

    ●
    The
    median OS in the PARPi + NACT group was 45.6 months and has not yet been reached in the PARPi + NACT + IMNN-001 group.

Imunon
also continues to see benefits in other secondary endpoints including an approximately 20% higher R0 tumor resection score and a doubling
of the CRS 3 chemotherapy response score to approximately 30% in the treatment arm versus 14% in the control arm. Chemotherapy response
score is considered a good prognostic indicator in ovarian cancer. The DSMB determined that safety analyses continue to show good tolerability
of IMNN-001 in this setting.

In
June 2024, the Company announced database lock for the OVATION 2 Study. At that time, median OS and PFS had been reached, and all patients
in the open-label study had achieved treatment observation duration of 16 months, as required by protocol to evaluate efficacy. On July
11, 2024, a scientific advisory board with