Immuneering Plans Phase 2 Trial of Atebimetinib Plus Chemotherapy in Anaplastic Thyroid Cancer: About 60 Patients, First Dosing Targeted Mid-2027
Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company based in New York, announced on November 12 that it plans to initiate a Phase 2 clinical trial evaluating its oral drug atebimetinib in combination with chemotherapy in patients with anaplastic thyroid cancer (ATC), a rare and highly aggressive form of thyroid cancer commonly driven by BRAF or RAS mutations and with significant unmet need.
The company 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, it expects to dose the first patient in mid-2027, with topline results potentially available 12 to 18 months after dosing begins. The preliminary 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.
Preclinical data supporting the rationale will be presented as a poster at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, taking place November 18-20, 2026, in Barcelona, Spain (Abstract 144, Poster PB-144, presenter Praveen Nair).
Alan Ho, M.D., Ph.D., Chief of the Head and Neck Oncology Service at Memorial Sloan Kettering Cancer Center, said anaplastic thyroid cancer remains one of the most challenging malignancies, with tumors that can progress extraordinarily quickly and limited treatment options for many patients. Immuneering co-founder and CEO Ben Zeskind, Ph.D., said results seen to date with atebimetinib in combination with chemotherapy in pancreatic cancer reinforced the company's conviction in the approach.
Atebimetinib is a once-daily oral deep cyclic inhibitor of MEK, a key control point in the MAPK pathway, and the company is conducting the global pivotal MAPKeeper 301 trial of the drug with chemotherapy in first-line pancreatic cancer. The planned ATC trial has not yet begun enrolling, and the drug's safety and efficacy for this indication have not been established. (Source: Immuneering)
Source: Immuneering
Published by GSM · USA (original Chinese edition)
Photo: 图：纪念斯隆凯特琳癌症中心位于纽约 First Avenue 的入口夜景；该中心头颈肿瘤科主任 Alan Ho 为本试验设计专家之一。Wikimedia Commons，CC BY-SA 4.0。 / Image: The Memorial Sloan Kettering Cancer Center entrance at night on First Avenue in New York; its head and neck oncology chief Alan Ho is among the experts who helped design the planned trial. Via Wikimedia Commons, CC BY-SA 4.0.
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