Company: IMRX
Filing Date: 2025-05-05
Form Type: 10-Q
Source: 0001790340-25-000061
Chunk: 496

Company: Immuneering Corp
Filing Date: 2025-05-05
Form: 10-Q
Item: Part I, Item 2
Chunk 496
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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 those harboring RAS or RAF 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 combination arms. 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 trial in the second quarter of 2025.

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