Company: IMRX
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001790340-25-000104
Chunk: 381

Company: Immuneering Corp
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 8
Chunk 381
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 Arm"). As of a data cutoff date of May 26, 2025 (the "Cutoff Date"), 94% overall survival ("OS") and 72% progression free survival ("PFS") were observed at six months in the intent-to-treat population of 34 patients dosed at the 320 mg once-daily dose level of atebimetinib in combination with mGnP (the "320 mg ITT Population"). As of the Cutoff Date, neither the median OS nor the median PFS of the 320 mg ITT Population had been reached and the median follow-up time was six months. Of the 36 response evaluable patients in the mGnP Arm dosed at the 240 mg or 320 mg once-daily dose level of atebimetinib in combination with mGnP, we observed an interim 81% (29/36) disease control rate ("DCR") and an interim 39% (14/36) overall response rate ("ORR"), in each case as measured by the Response Evaluation Criteria in Solid Tumors ("RECIST") method.

Further, we announced that as of the Cutoff Date, atebimetinib in combination with 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 ME