Company: IMRX
Filing Date: 2025-03-20
Form Type: 10-K
Source: 0001790340-25-000042
Chunk: 24

Company: Immuneering Corp
Filing Date: 2025-03-20
Form: 10-K
Item: Item 1
Chunk 24
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 ongoing Phase 2a arm evaluating IMM-1-104 monotherapy in second-line pancreatic cancer, eleven patients achieved disease control, including one patient that achieved a partial response with a sixty-seven percent (67%) target lesion reduction, in each case as measured by RECIST. The patient that achieved the forementioned partial response, and eight of the patients that achieved stable disease, remained on treatment. We also announced that, as of December 5, 2024, IMM-1-104 monotherapy was observed to be very well tolerated. As of December 5, 2024, treatment-related adverse events ("TRAEs") observed in ten-percent (10%) or greater of evaluable patients dosed with IMM-1-104 at 320mg (n=21) were mostly Grade 1 events, with some Grade 2 events observed including for: Rash (1 patient or 5%), Diarrhea (2 patients or 10%), Fatigue (1 patient or 5%) and Blurred Vision (1 patient or 5%); no Grade 3, Grade 4 or Grade 5 TRAEs were observed in this subset of the patient population.

Also in January 2025, we announced our plans to initiate in 2025 additional Phase 2a arms of IMM-1-104 in combination with a BRAF inhibitor for melanoma, in combination with a KRAS G12C inhibitor in non-small cell lung cancer, and in combination with checkpoint inhibitors for both melanoma and non-small cell lung cancer.

In February 2025, we announced entry into a clinical supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo® (cemiplimab), which intends to support the evaluation of IMM-1-104 in combination with Libtayo in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer.

We expect additional data from the Phase 2a portion of the IMM-1-104 trial in the second quarter of 2025.

Our Second Clinical Stage Program: IMM-6-415 

Our second program is focused on developing innovative allosteric MEK inhibitors that drive deep cyclic inhibition of the MAPK pathway, designed with unique drug-like properties including a shorter plasma half-life for an accelerated pharmacokinetic cadence dosed twice-daily in humans. Our product candidate for this program is designated as IMM-6-415, and is designed to target MEK in a way that disrupts the MAP