Company: IMRX
Filing Date: 2025-01-07
Form Type: 8-K
Source: 0001790340-25-000012
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Company: Immuneering Corp
Filing Date: 2025-01-07
Form: 8-K
Item: Item 8.01
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Item 8.01 Other Events.

Recent Developments

On January 7, 2025, Immuneering Corporation (the "Company", "we", "us" and "our") announced updated and initial interim response and safety data from three Phase 2a arms of the Company's ongoing Phase 1/2a clinical trial of IMM-1-104 in patients with advanced RAS-mutant solid tumors, and also announced initial interim pharmacokinetic (“ PK”), pharmacodynamic (“ PD”) and safety data from the Phase 1 portion of the Company's ongoing Phase 1/2a clinical trial of IMM-6-415 in patients with advanced solid tumors harboring RAF or RAS mutations.

Updated Interim Data from Ongoing Phase 2a Arm Evaluating IMM-1-104 with Modified Gemcitabine/nab-Paclitaxel (mGnP) in First-Line Pancreatic Cancer Patients

The Company announced that, as of December 5, 2024, of the seven evaluable patients in the ongoing Phase 2a arm evaluating IMM-1-104 with mGnP in first-line pancreatic cancer, one patient achieved a complete response, two patients achieved a partial response, three patients achieved stable disease, and one patient showed progressive disease, collectively representing an interim 86% (6/7) disease control rate (DCR) and an interim 43% (3/7) overall response rate (ORR), in each case as measured by RECIST. The three patients that achieved stable disease, and one of the patients that achieved a partial response, remained on treatment. The Company also announced that, as of December 5, 2024, IMM-1-104 in combination with mGnP was observed to be generally well tolerated. As of December 5, 2024, treatment-emergent adverse events (TEAEs) observed in ten-percent (10%) or greater of evaluable patients dosed with IMM-1-104 at 240mg (n=6) or 320mg (n=15) were mostly Grade 1 or Grade 2 events, with some Grade 3 events observed including for: Anemia (3 patients or 14%), Diarrhea (1 patient or 5%) and Neutrophil Count Decrease (2 patients or 10%); no Grade 4 or Grade 5 TEAEs were observed in this subset of the patient population.

Initial Interim Data from Ongoing Phase