Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 108

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 108
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, with 15
patients in the Phase I portion and up to 95 patients in Phase II. The sample size is consistent with a Phase II trial designed to inform
the design of a Phase III trial comparing IMNN-001 with neoadjuvant + adjuvant chemotherapy versus neoadjuvant + adjuvant chemotherapy
alone. As a Phase II study, the OVATION 2 Study was not powered for statistical significance. The primary endpoint is PFS and the primary
analysis would be conducted after at least 80 events had been observed or after all patients had been followed for at least 16 months,
whichever was later. Additional endpoints included objective response rate, chemotherapy response score, and surgical response.

16

On
March 23, 2020, the Company announced that the European Medicines Agency (the “EMA”) Committee for Orphan Medicinal Products
(“COMP”) had recommended that IMNN-001 be designated as an orphan medicinal product for the treatment of ovarian cancer.
IMNN-001 previously received orphan designation from the FDA.

In
February 2021, 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.