Company: IMRX
Filing Date: 2025-03-20
Form Type: 10-K
Source: 0001790340-25-000042
Chunk: 88

Company: Immuneering Corp
Filing Date: 2025-03-20
Form: 10-K
Item: Item 7
Chunk 88
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 traditional drug development approaches. Our pipeline also includes a discovery program targeting RAS, an undisclosed target, and other small molecule drug discovery programs.

In September 2022, the FDA cleared our IND application for IMM-1-104 and, in November 2022, we commenced dosing in our Phase 1/2a clinical trial of IMM-1-104 for the potential treatment of patients with advanced solid tumors including 

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those harboring RAS mutations. The Phase 2a portion includes evaluating IMM-1-104 in multiple dose expansion and combination arms. We began dosing the Phase 2a cohorts in March 2024.

In January 2025, we announced positive interim response and safety data from three Phase 2a pancreatic cancer arms of the IMM-1-104 clinical trial, as well as our plans to initiate 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. Additional data from the Phase 2a portion of the trial is expected in the second quarter of 2025.

In December 2023, the FDA cleared our IND application for IMM-6-415 and, in March 2024, we commenced dosing in our 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 is 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 includes 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. The Phase 2a portion includes evaluating IMM-6-415 in multiple dose expansion arms.

In January 2025, we announced initial interim PK, PD and safety data from the Phase 1 portion of the ongoing 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