On June 17, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, reported positive data from its ongoing Phase 2a clinical trial evaluating atebimetinib (IMM-1-104), an oral, once-daily novel MEK inhibitor, in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (Press release, Immuneering, JUN 17, 2025, View Source [SID1234653948]).

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"These exceptional data demonstrate the potential of atebimetinib plus mGnP to dramatically extend the lives of patients with advanced pancreatic cancer," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. "94% overall survival at 6 months is remarkable in first-line pancreatic cancer patients. Atebimetinib was designed to deliver exceptional durability and tolerability to a broad range of patients with different cancers, and it is deeply gratifying to see evidence of that playing out first in one of the most aggressive and deadly types of cancer. Our ultimate goal is to help cancer patients outlive their disease, and today’s announcement represents an important milestone on that journey."

Durability and Tolerability of Atebimetinib + mGnP Demonstrated in Phase 2a Data

94% overall survival (OS) was observed at 6 months in first-line (1L) pancreatic cancer patients treated with atebimetinib + mGnP at the 320 mg once-daily dose of atebimetinib (N=34). The benchmark 6-month OS for the standard of care treatment in this population (full dose and schedule GnP) is 67%.1 The median OS was not yet reached at the data cutoff date.
72% progression-free survival (PFS) was observed at 6 months in first-line (1L) pancreatic cancer patients treated with atebimetinib + mGnP at the 320 mg dose level (N=34). The benchmark 6-month PFS for the standard of care treatment in this population (full dose and schedule GnP) is 44%.1 The median PFS was not yet reached at the data cutoff date.
An overall response rate (ORR) of 39% and a disease control rate (DCR) of 81% were observed in response evaluable patients at both the 240 and 320 mg dose levels of atebimetinib + mGnP (N=36), including many patients with deepening, durable regressions and multiple examples of individual lesions rendered undetectable.
Atebimetinib continued to demonstrate a markedly favorable tolerability profile in combination with mGnP. No Grade 3+ events were observed in a majority of the adverse event categories commonly observed with standard of care chemotherapy in first line pancreatic cancer.
Based on these data, the Company has increased target enrollment in the 1L pancreatic cancer atebimetinib + mGnP combination arm to approximately 50 patients.
All results are reported using a data cutoff date of May 26, 2025.

"The encouraging clinical data reported thus far for atebimetinib (IMM-1-104) represent a potential new and significantly more durable treatment option for pancreatic cancer patients, for whom limited therapeutic options are currently available," said Vincent Chung, M.D., F.A.C.P., Professor, Department of Medical Oncology and Therapeutics Research at City of Hope, and principal investigator of the Phase 2a clinical trial. "I have treated pancreatic cancer patients with atebimetinib who have experienced exceptional durability. Current standard of care therapies in pancreatic cancer can be associated with limited durability and severe side effects, leading to poor patient outcomes. We have not seen significant improvement in standard of care for decades, and there is an urgent need for more durable and better tolerated new treatments that help patients live longer."

"These data clearly establish atebimetinib’s potential as a more durable and better tolerated MEK inhibitor positioned to help patients both live longer and live better, with exciting potential opportunities in pancreatic cancer and a variety of other cancers," said Igor Matushansky, M.D. Ph.D., Chief Medical Officer of Immuneering. "We look forward to advancing atebimetinib to a pivotal trial as rapidly as possible."

Dr. Chung is a paid advisory board member of Immuneering.

Near-Term Milestone Expectations

Building on these new Phase 2a clinical data, Immuneering is planning for several additional milestones related to atebimetinib, including:

Regulatory feedback on pivotal study plans in 4Q 2025
Data from additional patients in Phase 2a trial in 4Q 2025
Initiation of pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026
Initiation of additional atebimetinib clinical trial combination arms in 2026
Conference Call

Immuneering will host a conference call and live webcast at 8:00 a.m. ET / 5:00 a.m. PT on June 17, 2025, to discuss the data and provide a business update. Individuals interested in listening to the live conference call may do so by dialing (800) 715-9871 for U.S callers and (646) 307-1963 for other locations and reference conference ID 5641694, or from the webcast link in the "investors" section of the company’s website at www.immuneering.com. A webcast replay will be available in the investor relations section on the company’s website for 90 days following the completion of the call.