Company: IMRX
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001790340-25-000104
Chunk: 343

Company: Immuneering Corp
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 1
Chunk 343
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 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 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