Company: IMRX
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001790340-25-000104
Chunk: 506

Company: Immuneering Corp
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 2
Chunk 506
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 mGnP was observed to be generally well tolerated. As of the Cutoff Date, Grade ≥ 3 treatment-emergent adverse events ("TEAEs") observed in 10% or greater of patients in the 320 mg ITT Population were limited to Anemia (six patients or 18%) and Neutropenia (five patients or 15%), and no Grade 5 TEAEs were observed in this subset of the patient population.

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We expect regulatory feedback on our registrational trial plans for atebimetinib in combination with mGnP in first-line pancreatic cancer patients in the fourth quarter of 2025, as well as to provide updated OS and PFS data from the Phase 2a portion of the Phase 1/2a atebimetinib trial in the third quarter of 2025. Pending regulatory feedback, we plan to initiate a registrational, randomized controlled trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026. We also plan to initiate additional atebimetinib clinical trial combination arms in 2026. 

Our second product candidate IMM-6-415 aims to achieve broad activity with an accelerated twice-daily oral dosing cadence, also through deep cyclic inhibition of MEK. In December 2023, the FDA cleared our IND application for IMM-6-415 and, in March 2024, we commenced dosing in a Phase 1/2a clinical trial of IMM-6-415 for the potential treatment of patients with advanced solid tumors harboring RAF or RAS mutations. The Phase 1/2a clinical trial was designed to assess the safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMM-6-415. The Phase 1 portion of the clinical trial included dose escalation and dose exploration for IMM-6-415, using a mTPI-2 statistical design to establish an optimized RP2D in solid tumor patients with evidence of any RAF or RAS mutation.

In January 2025, we announced initial interim PK, PD and safety data from the Phase 1 portion of the IMM-6-415 Phase 1/2a clinical trial. In February 2025, we paused further patient enrollment in the IMM-6-415 Phase 1/2a clinical trial in order to evaluate the data from patients being treated at the 120 mg dose level and determine next steps for the program. In April