Company: IMRX
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001790340-25-000104
Chunk: 380

Company: Immuneering Corp
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 8
Chunk 380
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 while sparing healthy cells. Our inclusive approach differentiates us from chronically targeted precision therapies, which are generally limited by toxicity, resistance and/or application to specific mutations only.

We are currently evaluating our lead product candidate, atebimetinib (also referred to as IMM-1-104), in a Phase 1/2a clinical trial in patients with advanced or metastatic solid tumors. Atebimetinib is being developed as a once-daily oral deep cyclic inhibitor of the MAPK signaling pathway, specifically at the level of mitogen-activated protein kinase kinase ("MEK"). Atebimetinib is designed to improve tolerability and expand indications beyond currently registered MEK inhibitors to include RAS-driven tumors such as most pancreatic cancers.

DCI is a novel mechanism that aims to deprive tumor cells of the sustained proliferative signaling required for rapid growth, while sparing healthy cells through a cadenced, normalized level of signaling. This mechanism was engineered using our proprietary informatics-based discovery platform. The development of our pipeline is translationally guided by our proprietary, human-aligned 3D tumor modeling platform that we combine with bioinformatics-driven patient profiling, which we believe has the potential to increase the probability of success in clinical development versus 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 atebimetinib and, in November 2022, we commenced dosing in our Phase 1/2a clinical trial of atebimetinib for the potential treatment of patients with advanced or metastatic solid tumors. The Phase 2a portion includes evaluating atebimetinib in multiple dose expansion and combination arms. We began dosing the Phase 2a cohorts in March 2024.

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 atebimetinib in combination with Libtayo in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer. 

In June 2025, we announced positive interim data from our ongoing Phase 2a clinical trial arm evaluating atebimetinib in combination with modified Gemcitabine/nab-Paclitaxel ("mGnP") in first-line pancreatic cancer patients (the "mGnP