- Company plans to evaluate atebimetinib in combination with chemotherapy in a Phase 2 clinical trial in patients with anaplastic thyroid cancer (ATC), a highly aggressive cancer with significant unmet need commonly driven by BRAF or RAS mutations -
- IND submission planned by year-end 2026, with first patient dosing targeted for mid-2027; study is designed to be potentially registrational -
- Preclinical data supporting the rationale for atebimetinib + chemotherapy in ATC to be presented at the 38th EORTC-NCI-AACR Symposium on November 18, 2026 –
- Aligns with Immuneering’s strategy to provide a broad population of cancer patients with important new treatment options –
- Company to hold investor webcast today at 8:30am EST, to discuss both of today’s news announcements; including its clinical development plans in anaplastic thyroid cancer and the collaboration to evaluate CLDN18.2 programs in combination with atebimetinib for pancreatic cancer -
NEW YORK, Nov. 12, 2026 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, today announced plans to initiate a Phase 2 clinical trial evaluating atebimetinib in combination with chemotherapy in patients with anaplastic thyroid cancer (ATC), a highly aggressive form of thyroid cancer with significant unmet need, commonly driven by BRAF or RAS mutations.
Immuneering plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the program by the end of 2026. Subject to regulatory clearance, Immuneering currently expects to dose the first patient in the study in mid-2027, with topline results potentially available 12-18 months after dosing begins. The preliminary study plan is to enroll approximately 60 patients with ATC who progressed on standard of care, including an all-comers cohort and a BRAF V600E cohort. The study is designed to be potentially registrational, pending discussion with regulators.
ATC is one of the fastest growing and most aggressive forms of cancer. While it accounts for a small percentage of all thyroid cancers, its rapid progression and poor prognosis result in a disproportionately high share of thyroid cancer-related deaths. It is commonly driven by the MAPK pathway. BRAF mutations are the most frequently occurring alterations, and the majority of patients have tumors driven by either BRAF mutations or RAS mutations. New treatment options capable of delivering durable tumor control while maintaining tolerability are urgently needed.
“Anaplastic thyroid cancer remains one of the most challenging malignancies we encounter, with tumors that can progress extraordinarily quickly and limited treatment options for many patients,” said Alan Ho, M.D., Ph.D., Chief of the Head and Neck Oncology Service at Memorial Sloan Kettering Cancer Center. “Despite important advances for certain molecularly defined subsets of patients, there remains a substantial need for new therapeutic approaches that can provide durable disease control for a broader population of patients with ATC.”
“Atebimetinib has the potential to help patients with many different types of cancer, and to be synergistic in many different combinations,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. “The exciting results we have observed to date with atebimetinib in combination with chemotherapy in pancreatic cancer has reinforced our conviction in this approach. With MAPK pathway activation a defining feature of anaplastic thyroid cancer, and BRAF and RAS mutations among its key drivers, deep cyclic inhibition of MAPK signaling with atebimetinib represents an innovative, promising therapeutic approach in combination with chemotherapy for addressing the significant unmet need in anaplastic thyroid cancer. We are grateful to the esteemed group of world-class thyroid cancer experts who have helped design this study and encouraged us to pursue it with a high degree of optimism, and together we are moving full speed ahead.”
The scientific rationale supporting the planned clinical program will be highlighted in a preclinical poster at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, taking place November 18-20, 2026, in Barcelona, Spain.
Poster Presentation Details:
Title: Atebimetinib, a deep cyclic inhibitor of MEK, combined with chemotherapy: preclinical rationale for treatment of anaplastic thyroid cancer (ATC).
Abstract Number: 144
Poster Number: PB-144
Presenter: Praveen Nair
Date: Wednesday, November 18, 2026
Following presentation, the poster is expected to be available on the publications section of Immuneering’s website.
Conference Call
Immuneering will host a conference call and live webcast at 8:30 a.m. EST on November 12, 2026, to discuss today’s news announcements. 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 6087332, 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.
About Anaplastic Thyroid Cancer
Anaplastic thyroid cancer, or ATC, is a rare and highly aggressive form of thyroid cancer characterized by rapid tumor growth and invasion into surrounding tissues. According to the National Cancer Institute, ATC accounts for approximately 1% to 2% of thyroid cancer cases and affects approximately one to two people per million each year in the United States. Unlike most other forms of thyroid cancer, ATC can progress extremely rapidly and frequently presents with locally advanced or metastatic disease. Standard of care chemotherapy remains a primary treatment option for ATC, however these cytotoxic agents can induce MAPK reactivation, potentially limiting response durability. Although advances in targeted therapies have improved outcomes for some patients with specific molecular alterations, there remains a substantial unmet need for new treatment approaches capable of providing durable disease control across a broader population of patients with ATC.
About Atebimetinib
Atebimetinib is the first in a new category of oral drug candidates, Deep Cyclic Inhibitors (DCIs), designed to improve overall survival by three mechanisms: shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize performance status and combinability. Each of these mechanisms has been well established to improve survival in published studies. DCIs challenge the conventional model of sustained or continuous inhibition in oncology. Whereas most therapies are designed for sustained inhibition, driving cancer to adapt and develop resistance so tumors shrink quickly but temporarily, DCIs are designed to pulse faster than tumors can adapt, so tumors shrink slowly but durably. Moreover, DCIs aim to restore full transient signaling to healthy cells, with the goal of leading to fewer adverse events. Atebimetinib targets MEK, a key control point in the MAPK pathway (RAS-RAF-MEK-ERK), which is pathologically activated in a majority of cancers, including approximately 97% of pancreatic cancers. Targeting MEK blocks a broader range of MAPK pathway alterations because it is further downstream, creating the potential for more durable benefit.
About Immuneering Corporation
Immuneering is a late-stage clinical oncology company dedicated to keeping cancer patients alive and helping them thrive, with an initial focus on patients with RAS, RAF, and other MAPK-driven cancers. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors, designed to improve overall survival by three mechanisms: shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize performance status and combinability. Immuneering’s lead product candidate, atebimetinib, is an oral, once-daily Deep Cyclic Inhibitor of MEK, designed to improve survival across many cancer indications. The Company is conducting a global randomized pivotal trial, MAPKeeper 301, evaluating atebimetinib in combination with chemotherapy in first-line pancreatic cancer patients. The Company’s development pipeline also includes additional combination opportunities and preclinical stage programs. For more information, please visit www.immuneering.com.
Forward-Looking Statements
This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: the treatment potential of atebimetinib, alone or in combination with other agents to treat a wide range of cancers, including in combination with chemotherapy in ATC; the ability of atebimetinib to be synergistic in many different combinations; the significant unmet need in ATC; the Phase 2 study design for ATC, the timing of submission of the IND and regulatory clearance, dosing of patients and availability of topline results for such study; the potential of the Phase 2 study in ATC to be registrational; and that preclinical data demonstrating efficacy in ATC models may translate into human clinical trial data.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we are a late-stage clinical oncology company with a limited operating history and have not completed any registrational clinical trials; we have incurred significant losses, are not currently profitable and may never become profitable; limitations on our cash runway and potential increases in expenditures; our need for additional funding; our unproven approach to therapeutic intervention; our ability to address regulatory questions and changing regulatory standards, and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including the uncertainty of whether positive preclinical or early clinical efficacy and safety results are confirmed in later-stage trials, potential delays in activation of trial sites or enrollment of trial participants, or failure to obtain regulatory clearance or approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports.
These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended September 30, 2026, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Investor Contact:
Laurence Watts
New Street Investor Relations
laurence@newstreetir.com
Media Contact:
David Caouette
dcaouette@immuneering.com
