Immuneering is advancing a robust clinical pipeline beginning with atebimetinib, our oral, once-daily Deep Cyclic Inhibitor of MEK. Our programs include ongoing clinical trials in pancreatic cancer, lung cancer, and other solid tumors, evaluating atebimetinib as both combination therapy and monotherapy.
| Program | Discovery | IND-enabling | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|---|---|
| Pancreatic Cancer | |||||
Atebimetinib + mGnP, 1L |
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Immuneering’s global Phase 3 trial (MAPKeeper 301) will evaluate atebimetinib, its lead Deep Cyclic Inhibitor, in combination with modified gemcitabine and nab-paclitaxel (mGnP), compared to standard of care GnP alone, in first-line metastatic pancreatic ductal adenocarcinoma. The company expects to begin enrollment in mid-2026. | |||||
Atebimetinib + mGnP, 1L |
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Immuneering’s Phase 2 trial is evaluating atebimetinib, its lead Deep Cyclic Inhibitor, in combination with modified gemcitabine and nab-paclitaxel (mGnP), in first-line metastatic pancreatic ductal adenocarcinoma. | |||||
Atebimetinib + mFOLFIRINOX, 1L |
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Immuneering is evaluating atebimetinib, its lead Deep Cyclic Inhibitor, in combination with mFOLFIRINOX (modified FOLFIRINOX chemotherapy) in a Phase 2 clinical trial to evaluate how Deep Cyclic Inhibition supports enhanced durability of response and improved tolerability for patients with first-line pancreatic cancer. | |||||
| Lung Cancer | |||||
Atebimetinib + PD-1 +/- chemo, 1L (Regeneron Clinical Supply Agreement) |
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Immuneering has entered into a clinical supply agreement with Regeneron Pharmaceuticals to evaluate atebimetinib, Immuneering’s lead Deep Cyclic Inhibitor, in combination with Regeneron’s Libtayo (cemiplimab), an FDA-approved PD-1 checkpoint inhibitor, with or without chemo, based on tumor PD-L1 status, in a Phase 2 clinical trial in patients with 1L metastatic RAS-mutant non-small cell lung cancer. Immuneering expects to dose the first patient in the second half of 2026. | |||||
| Other Solid Tumors | |||||
Envometinib (IMM-6-415) |
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Completed in April 2025, this first-in-human, ascending dose study characterized the safety, tolerability, optimal dose and preliminary anti-tumor activity of Envometinib (IMM-6-415) in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic mutations. Envometinib is a Phase 2-ready asset available for partnering. | |||||
| Multiple Deep Cyclic Inhibitor Discovery Programs | |||||
| Pancreatic Cancer | ||||
Atebimetinib + mGnP, 1L Immuneering’s global Phase 3 trial (MAPKeeper 301) will evaluate atebimetinib, its lead Deep Cyclic Inhibitor, in combination with modified gemcitabine and nab-paclitaxel (mGnP), compared to standard of care GnP alone, in first-line metastatic pancreatic ductal adenocarcinoma. The company expects to begin enrollment in mid-2026. | ||||
| Discovery | IND-enabling | Phase 1 | Phase 2 | Phase 3 |
Atebimetinib + mGnP, 1L Immuneering’s Phase 2 trial is evaluating atebimetinib, its lead Deep Cyclic Inhibitor, in combination with modified gemcitabine and nab-paclitaxel (mGnP), in first-line metastatic pancreatic ductal adenocarcinoma. | ||||
| Discovery | IND-enabling | Phase 1 | Phase 2 | Phase 3 |
Atebimetinib + mFOLFIRINOX, 1L Immuneering is evaluating atebimetinib, its lead Deep Cyclic Inhibitor, in combination with mFOLFIRINOX (modified FOLFIRINOX chemotherapy) in a Phase 2 clinical trial to evaluate how Deep Cyclic Inhibition supports enhanced durability of response and improved tolerability for patients with first-line pancreatic cancer. | ||||
| Discovery | IND-enabling | Phase 1 | Phase 2 | Phase 3 |
| Lung Cancer | ||||
Atebimetinib + PD-1 +/- chemo, 1L (Regeneron Clinical Supply Agreement) Immuneering has entered into a clinical supply agreement with Regeneron Pharmaceuticals to evaluate atebimetinib, Immuneering’s lead Deep Cyclic Inhibitor, in combination with Regeneron’s Libtayo (cemiplimab), an FDA-approved PD-1 checkpoint inhibitor, with or without chemo, based on tumor PD-L1 status, in a Phase 2 clinical trial in patients with 1L metastatic RAS-mutant non-small cell lung cancer. Immuneering expects to dose the first patient in the second half of 2026.
| ||||
| Discovery | IND-enabling | Phase 1 | Phase 2 | Phase 3 |
| Other Solid Tumors | ||||
Envometinib (IMM-6-415) Completed in April 2025, this first-in-human, ascending dose study characterized the safety, tolerability, optimal dose and preliminary anti-tumor activity of Envometinib (IMM-6-415) in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic mutations. Envometinib is a Phase 2-ready asset available for partnering. | ||||
| Discovery | IND-enabling | Phase 1 | Phase 2 | Phase 3 |
Multiple Deep Cyclic Inhibitor Discovery Programs | ||||
| Discovery | IND-enabling | Phase 1 | Phase 2 | Phase 3 |